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Latest CPD Courses
109394| Charis Management Systems| ISO 9001:2015: What Senior Management Need to Know [IRCA CPD C18178}|

The 2015 version of ISO 9001 was released in September 2015. One of the key changes in the standard included a greater emphasis on Leadership and Management

OverviewThe 2015 version of ISO 9001 was released in September 2015. One of the key changes in the standard included a greater emphasis on Leadership and Management Commitment and also the removal of the stated requirement for a nominated management representative. What do these new requirements mean for managers, senior managers and directors of businesses, both small and large? How can the senior management of a company demonstrate that they meet these requirements in practice and imbibe the leadership requirements in the daily culture of our organisation? In a single half-day, this course provides all the tools time poor senior managers need to comply with the leadership requirements of ISO 9001:2015. Aim of the CourseThis course aims to provide delegates with experience of managing ISO 9001 certified companies with an understanding of what is required of them under the 9001:2015 dispensation. And to provide them the knowledge required to identify and manage the critical requirements/parameters laid out by the standard as the direct responsibilities of leadership/management Objectives of CourseDelegates will, at the end of the course be able to

  • Understand the responsibilities and specific requirements for leadership and management in ISO9001
  • Identify various ways of meeting the stated requirements within the context of a range of organisations
  • Gain the knowledge and tools required to effectively lead the organisation’s management system to achieve organization’s own objectives

 Course Duration½ day 3.5 hour intensive - 9:00am- 12:30pmAssessmentThere is NO formal written examination on this course. However to be successful on the course delegates must

  • Complete/attend all elements of the course.
  • Demonstrate achievement of the learning and enabling objectives

PrerequisiteExperience of managing an ISO 9001 certified organisation or organisation seeking certification to ISO 9001 Detailed Course OutcomesDelegates will as a minimum, come out of the course able to do the following

  • Set and review policy and objectives to achieve organisational goals and ISO 9001 requirements.
  • Provide leadership for the integration of QMS requirements to organisation’s own processes
  • Understand and communicate the purpose and potential benefits of ISO 9001 to all stakeholders, not just the owners/shareholders
  • Specifying intended results of the QMS and leading and managing the achievement of such Understand process approach and risk-based thinking
  • Achieving effective promotion, communication and awareness of the QMS throughout the organisation including directing and supporting others.
  • Be clear on how to be accountable for the QMS
  • Conduct an effective management review of the QMS

 

109393| VetPD - Veterinary Professional Development| Equine Medical Ultrasound & Diagnostic Techniques for Equine Practitioners - A 2-Day Practical Course|

Speakers/Instructors: Andy Durham, Bruce McGorum and Ben Sykes

This 2-day practical course is suitable for veterinarians from mixed and equine practice who are keen to update their knowledge and especially their practical skills on most diagnostic techniques currently used in equine medicine: Abdominal, thoracic and ocular ultrasound (incl. ultrasound-guided pleural aspiration techniques), peritoneal taps, cardiac auscultation & its interpretation, respiratory tract endoscopy (incl. BAL, TW & guttural pouch lavage techniques etc.), pleural drainage, different biopsy techniques, emergency tracheotomy, subpalpebral lavage placement and local anaesthetic techniques used for headshaking cases etc..

The experienced and world-renowned specialists in equine medicine Prof. Andy Durham (Liphook, England), Prof. Bruce McGorum (Edinburgh, Scotland) and Dr. Ben Sykes (Upper Orara, Australia) will supervise the 7 hours of practical and case-based sessions where the attendees will have plenty of opportunity to put theory into practice on live horses and cadaver specimens in true small groups (2-4 attendees per ultrasound machine).

 

Register before 11 July 2016 to qualify for the early booking discount!

For further details, program and registration: http://www.vetpd.com/courses-detail.php?event=293

109392| VetPD - Veterinary Professional Development| Equine Medical Ultrasound & Diagnostic Techniques for Practitioners - A 2-Day Practical Course|

Speakers/Instructors: Andy Durham and Bruce McGorum

This 2-day practical course is suitable for veterinarians from mixed and equine practice who are keen to update their knowledge and especially their practical skills on most diagnostic techniques currently used in equine medicine:  Abdominal, thoracic and ocular ultrasound (incl. ultrasound-guided pleural aspiration techniques), peritoneal taps, cardiac auscultation & its interpretation, respiratory tract endoscopy (incl. BAL, TW & guttural pouch lavage techniques etc.), pleural drainage, different biopsy techniques, emergency tracheotomy, subpalpebral lavage placement and local anaesthetic techniques used for headshaking cases etc.. 

The experienced and world-renowned specialists in equine medicine Prof. Andy Durham (Liphook, England) and Prof. Bruce McGorum (Edinburgh, Scotland) will supervise the 5 ½ hours of practical and case-based sessions where the attendees will have plenty of opportunity to put theory into practice on live horses and cadaver specimens in true small groups (2-4 attendees per ultrasound machine).

Register before 11 July 2016 to qualify for the early booking discount.

109365| Faculty of Health and Medical Sciences, University of Copenhagen| Quality by Design (QbD) in Pharmaceutical Development|

Quality by Design (QbD) is at the very heart of modern pharmaceutical development. The implementation of QbD principles provides a cost-efficient approach to delivering high quality medicines for patients. Regulatory authorities, both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), are placing great emphasis on the QbD component as a part of regulatory filing. QbD has become a crucial element in a stream-lined drug development process.

This course will provide insight into the key principles of QbD covering quality risk management, formal experimental design and process analytical technology (PAT). Leading QbD experts ­ from industry, the regulatory side and the academic world ­will introduce the current knowledge on QbD and provide participants with ideas about, how this knowledge can be implemented in their companies. The course includes practical demonstrations.

""It has been a fantastic course – the best I have attended in years! All persons that gave lectures were very enthusiastic and dedicated to their work – this was so GREAT and motivating- thanks."

Birgit Sølvkær Jensen, Scientific Adviser, Leo Pharma.

Course content

The course will provide a thorough introduction to the underlying principles and tools required for QbD-based pharmaceutical development and manufacturing:

  • Basic risk analysis techniques.
  • Constructing the quality target product profile (QTPP).
  • Identification of critical quality attributes (CQAs) and critical process parameters (CPPs).
  • Design of Experiments (DoE): Basic screening designs
    and expanded designs.
  • Process Analytical Technologies (PAT): Basic principles of chemometrics, examples of process measurements both with examples of small molecules and biopharmaceuticals.
  • Risk-based regulatory framework.

Course dates

5 days, 15 – 19 August 2016, 9:00 – 16:30 at the University of Copenhagen, Frederiksberg Campus, Bülowsvej 17, DK-1870 Frederiksberg, Denmark.

""The course was very well organised and gave an excellent mix of activities throughout each day. All guest lecturers were excellent."

Susan Fetherston, Development Engineer, QPharma AB.

Course fee:DKK 19,000. Fee includes teaching, course materials, and all meals during course and examination.

Participants

The course is intended as continuing professional development (CPD) for professionals in the pharmaceutical industry, particularly in production, regulatory affairs and quality functions. The course will offer an excellent introduction for those less familiar with QbD
and provide those with more experience with QbD, new ideas on how to further implement the company’s QbD programme. The course is preapproved as an elective in the Master of Industrial Drug Development (MIND) programme and the Master of Pharmaceutical Regulatory Affairs (MPRA) programme. It has been developed in co-operation with the Steering Committee of the EUFEPS QbD and PAT Sciences Network (EUFEPS, European Federation for Pharmaceutical Sciences).

Participants must:

  • Hold a relevant bachelor degree or equivalent
  • Have a minimum of 2 years of relevant job experience
  • Have proficiency in English
109363| Faculty of Health and Medical Sciences, University of Copenhagen| Pharmacology|

Why should you enroll in this course?

MIND Pharmacology offers a broad education in all pharmacological disciplines used for drug candidate selection. Through lectures and workshops within in vitro pharmacology, in vivo disease animal models, pharmacokinetics and ADMET, the course offers participants to work with real challenges of ‘drug candidate pharmacological behavior’ in the drug development process. The broad nature of the course enables participants to understand a large variety of central goals and challenges in drug discovery and development and to optimize work across specialist areas in his or her own organization. The course offers high level pharmacological science as well as hands-on experience with pharmacokinetic and pharmacodynamic study design, data analysis and data interpretation.

The course will teach the basic concepts of general pharmacology. Emphasis is on pharmacokinetics with hands-on calculations. It runs over two days and is computer aided. There is focus on experimental in vitro and in vivo tools and on animal experimental models for various diseases including modern experimental techniques.

The course covers the following areas:

  • General pharmacology (pharmacodynamics)
  • Pharmacokinetics (basic concepts, extra vascular dosing using a one-compartment model, IV administration using 1- and 2 compartment models, elimination: metabolism and excretion, hands-on calculation in an Excel spreadsheet)
  • Exploratory pharmacology (measurement of pharmacological effect, safety pharmacology)
  • In vitro pharmacology, concepts and methodology (ADME; biomarkers; metabolism; transporters)
  • In vivo pharmacology, methodology (animal models for cardiovascular diseases, obesity, bone and joint diseases and pain; behavioural animal models.)

"What I like about this course is that it is not only theory, mathematical formulas and dose response curves, but there is also focus on how we can use this in our daily work

Madaleine Dahlbäck, Senior Scientist, Novo Nordisk

What do you gain?

  • Obtain basic and integrated understanding of pharmacology methodology in drug discovery and development disciplines
  • Understand and conduct state-of the art calculations and data interpretations within pharmacokinetics and especially within pharmacodynamics
  • Broad understanding of all aspects of ADMET based drug candidate selections
  • Understand basic validation of animal models for in vivo pharmacological drug candidate selection
  • Understand and validate methods applied for in vitro pharmacological drug candidate selection
  • Obtain a large overview of current state-of-the art pharmacology models
  • Professional communication skills within pharmacological terminology

"The course is of the highest quality, especially the last two days have been intense with competent lecturers who have extensive knowledge of their area while they at the same time are able to convey their knowledge in an exciting and relevant way

Casper Tind Hansen, CEO, Pcovery

MIND Pharmacology contains lectures and discussions throughout all aspects of applied pharmacology in drug discovery and developments processes. Experienced specialists from Leo Pharma, Novo Nordisk, Lundbeck and Copenhagen University presents basic and applied pharmacology illustrated with state-of-the art examples. Whereas topics include in vitro and in vivo pharmacological drug candidate selection and ADMET drug candidate selection criteria, a special focus will be given to pharmacokinetic modeling, calculation and data interpretation. You will have good opportunities to network during discussion, workshops, and breaks.

Dates: 2-5/5 + 8/5 2017

Price:

  • DKK 10,750 for EU/EEA citizens  
  • DKK 12,543 for non-EU/EEA citizens
109361| Faculty of Health and Medical Sciences, University of Copenhagen| Market Access for Pharmaceutical Products – trends and challenges|

Market Access for Pharmaceutical Products – trends and challenges

In the competitive world of pharmaceutical sales, developing a market access strategy and communicating the value of the brands to the ‘payers’ is at the top of the agenda. In recent years, the field of pricing and reimbursement of pharmaceuticals has become more complex and challenging.

Although everyone seems to be talking about market access, very few are able to define it. Who are the new key stakeholders, exactly? Is it no longer the prescribers that decide which drug a patient should use? Is market access only about containing costs for the public budgets or are the benefits for patients and society as well?

 

What you will learn

After the course, you will have strengthened your capacity to understand and deal with crucial market access issues. You will have learned about key trends in market access and how market access decisions are made and how the decision frameworks affect requirements for evidence for new health care interventions. You will have acquired:

  • A basic market access vocabulary.
  • Insight into the toolbox of the market access methodologies.
  • An understanding of market access and its relation to the entire pharmaceutical organization. Insight into the key challenges of obtaining market access.
  • Knowledge of the key stakeholders and their influence on the drug reimbursement and prescription process.
  • An understanding of the requirements and different perspectives of payers from key markets and how they are changing.

Course content

This course will provide insight into the key principles and a practical understanding of ‘market access’ as it relates to the pharmaceutical industry. The course starts with an overview of the key stakeholders and current trends in the global market access of pharmaceuticals followed by a review of the hot topics, challenges and relevant issues through a combination of lectures, discussions, group work, and case studies.

"Interesting topic, well covered by the diverse teachers.

Hans Schambye,  CEO, Galecto Biotech AB

Course dates

5 days, 22 – 26 August 2016, 9:00 – 16:30 at the University of Copenhagen, Frederiksberg Campus, Bülowsvej 17, DK-1870 Frederiksberg, Denmark.

Price: DKK 19,000. The fee includes teaching, course materials, and all meals during the course and examination.

Participants

The course is for professionals working in the field of pharmaceuticals. It is intended as continuing professional development for professionals in the pharmaceutical industry, particularly in regulatory affairs, medical affairs and sales and marketing, including decision-makers and administrators in the public and private sectors. The course offers an excellent introduction for those less familiar with market access and will provide a deeper understanding for those with experience within administration and marketing. Please note, however, that the course is not an advanced course for market access specialists.

109360| Faculty of Health and Medical Sciences, University of Copenhagen| Drug Regulatory Affairs in Drug Development|

Why should you enroll in this course?

All aspects within the pharmaceutical development process of medicinal products are subject to various degree of regulation. The pharmaceutical law frame, guidelines, Health Authorities' attitudes and requirements have a significant influence on the drug development process and its success rate. Knowing how to focus the development process in regards to regulatory affairs and co-operate with the regulatory affairs professionals can be vital for the success of a medicinal product and the survival of a pharmaceutical company.

This course is designed to give you the necessary basic background to understand and incorporate drug regulatory affairs in the drug development process.
The contents will cover the role and responsibility for the drug regulatory affairs professionals – how they are involved in the development process, how to co-operate with this function, the pharmaceutical law frame in EU, US and outside EU/US, the application and approval procedures, regulatory strategic issue, how to build up an application for a marketing authorization, variations, incentives, pharmacovigilance, and how to approach the issues of Quality, Safety and Efficacy from a regulatory point of view.

What do you gain?

Upon completion of the course you will have an extensive overview and understanding of the drug regulatory affairs in drug development and be able to:

  • Understand the role of regulatory affairs in the drug development process, particularly in respect of requirements to quality, safety and efficacy
  • Understand the law frame and guidelines within regulatory affairs
  • Discuss the law frame and guidelines within regulatory affairs
  • Understand, interpret and follow regulatory guidelines
  • Apply knowledge of regulatory affairs in your daily work
  • Recognize the different types of applications and application procedures available in the EU, US and outside EU/US

The faculty of the course includes a series of experts both from regulatory affairs departments in industry and from the regulatory authorities. In this way the students will receive detailed information from people with hands-on experience in regulatory affairs in their daily work.

The course participants include people from different companies and institutions and with a variety of professional roles. This facilitates the lively discussions during the lectures and even during the breaks.

Date: 31/10-4/11 2016

Price:

  • DKK 10,750 for EU/EEA citizens
  • DKK 12,543 for non-EU/EEA citizens
109359| Faculty of Health and Medical Sciences, University of Copenhagen| Drug Formulation and Delivery|

Why should you enroll in this course?

The best drug cannot help the patient if it is not formulated into a medicine in an optimal way.  The drug needs to be delivered in the right dose, at the right time, to the right target in the body. This course will introduce the participant to the principles of drug formulation and delivery. If you want to know more about different dosage forms, different routes of administration and the physicochemical and physiological principles underlying modern drug delivery, this course is for you.

The ultimate aim of drug formulation is to deliver the active pharmaceutical ingredient (API) through biological membranes to the right target in the right concentration during a defined time interval. Optimal performance of the drug formulation can be achieved by considering the physicochemical properties of API and excipients, along with both the pharmacological properties and processability of a given formulation. Understanding the most relevant factors affecting the drug product performance enables the development of an optimal pharmaceutical product.

The course will consist of 12 lectures covering different concepts related to designing a dosage form and delivering the active pharmaceutical ingredient to the right target. Lectures will cover the importance of biological and metabolic barriers related to delivery, role of preformulation/processing, and finally, the design of formulation –specific lectures will be on solid dosage forms, semisolids, inhalation products, and macromolecular delivery systems.

What do you gain?

  • Upon completion of this course you will think of the delivery of drugs in a pharmaceutical way.
  • You will have learned how the dosage form can be tailored to the needs of the patient and disease to be treated.
  • You will be able to decide what administrative route, and delivery systems might be optimal for a given drug.
  • You will have learned about the physicochemical and physiological principles that are forming the basis of a rational development of modern dosage forms.

We have assembled a unique team of both industrial and academic speakers, who are experts in specific dosage forms, formulation principles and the underpinning sciences. The mixture between academia and industry speakers gives you a well-rounded perspective on both the theoretic background and the application of modern drug delivery.

Date: 28/11-2/12 2016

Price:

  • DKK 17,200 for EU/EEA citizens
  • DKK 20,068 for non-EU/EEA citizens
109358| Faculty of Health and Medical Sciences, University of Copenhagen| Deal-making in the Pharmaceutical Industry|

Why should you enroll in this course?

Pharmaceutical industry, biotech and Contract Research Organizations often exchange pharmaceutical services, pharmaceutical inventions or potential drug candidates. Such pharmaceutical business to business deals are often complex and require critical assessment of scientific validity, process, quality, IPR and valuation. The course offers a comprehensive overview of pharmaceutical deal making processes on different levels of complexity, including pharmaceutical due diligence. The course will engage you in deal making cases from different perspectives; Pharma, Contract Research Organizations and Biotech.

Deal-making in the Pharmaceutical Industry is aimed at current and future leaders of pharmaceutical deal-making processes and specialists involved in any part of the deal-making process from donor to receiver of pharmaceutical B2B. By attending this course you will be supported in optimizing your specialist inputs and improve your collaborations, through interactions and discussions with leading experts in this field.

The course contains lectures and case-based workshops focusing on major aspects of leading and executing the pharmaceutical deal-making process.  

What do you gain?

Through the course you will obtain a basic and integrated understanding of deal-making in the Pharmaceutical Industry, its value chain and responsibilities for sponsor as well as receiver within the following themes:

  • Overview of deal types: marketing agreements, Licensing agreement/Product acquisition, Joint venture (CRO2Pharma, Biotech2Pharma, Pharma2Pharma, Pharma2CRO, pharma/academia).
  • Integration of information, communication, specialist and process knowledge in order to manage and contribute to complex pharmaceutical deal making processes
  • Identify key challenges in pharmaceutical deal making processes and to take responsibility for solving these, in cooperation with other specialists.

Experienced leaders and specialists from the pharmaceutical industry (e.g. Leo Pharma, Novo Nordisk, Lundbeck), biotech (e.g Serodus ASA, Astion, Gubra, Zealand Pharma) and CROs (e.g. Gubra, Scantox, Aptuit) will share processes, experiences and major learning about successful and challenging deal making  processes.

You will have good opportunities to network during discussion workshops and breaks.

Dates:  28/11-2/12 2016.

Price:

  • 12,900 DKK for EU/EAA citizens
  • 15,051 DKK for non-EU/EAA citizens
109356| Faculty of Health and Medical Sciences, University of Copenhagen| Chemical Process Development and Production of API|

Why should you enroll in this course?

The development of a safe and efficient manufacturing process of an active pharmaceutical ingredient (API) or bulk drug substance is a substantial undertaking. A successful endeavour requires solving problems within synthetic organic, bioorganic, physical organic, analytical and environmental chemistry, engineering, and economics. An understanding of chemical development and the particular challenges during each phase is the primary focus of this course. A combination of theory and practice using fresh examples from industry and the literature will create the foundation for solid decision-making skills and an understanding of the trade terminology.

If you wish to learn how you efficiently produce a new medicine this is the course for you. You may have occasional or more regular contact with producers or departments working with process development, or even wish to enter the field yourself, and therefore would like to know more about how this work is performed. Attending this course will give you a good insight in the processes, regulations and options for the production of both small molecule and biopharmaceutical drugs.

What do you gain?

  • Upon completion of this course you will be familiar with the terms, principles and methods used in developing a chemical process from discovery to routine manufacturing.
  • You will be able to discuss different aspects and solutions to problems in a broad range covering scale-up, organization, planning, process monitoring, validation, life cycle management, registration, resource consumption, environmental and safety issues.
  • You will be able to closely interact with specialists and work as project leader where process development is a part of the project.
  • You will have learned how to identify and explain common risks and problems in process development.
  • You will be able to compute and critically apply various process metrics.

We have assembled a unique team of industrial speakers, who are experts in process development and production of pharmaceutical ingredients. The course will cover both the theoretic background and give an industrial perspective on modern drug production and regulations.

Dates: 14-18 November 2016

Price:

  • DKK 12,900 for EU/EEA citizens
  • DKK 15,051 for non-EU/EEA citizens
109355| Faculty of Health and Medical Sciences, University of Copenhagen| Biopharmaceuticals Drug Development|

Biopharmaceuticals Drug Development

The complexity of drug development, in particular pharmaceutical development and safety assessment, still poses large challenges in the overall development of novel biopharmaceuticals. This course provides an interdisciplinary introduction to the newest advances in our ability to develop effective biopharmaceuticals.

Recent advances in genetics, biotechnology, and knowledge of protein function in the biology of diseases have provided an explosion of novel opportunities for development of biopharmaceuticals. At first sight, development of biopharmaceuticals appears straightforward since the biology of endogenous compounds, such as proteins or peptides, and clinical proof of concept and safety profile often are given beforehand (e.g. insulin, growth hormone, coagulation factors). But although discovery and development of novel biopharmaceuticals may be void of typical small molecule pitfalls, the delivery and formulation challenges are complex and call for a high degree of interdisciplinary approaches.

A short introduction to the course (opens a new window)

Course content

The course uses a high degree of case-based learning with cases based on real-life examples. It is a major aim of the course to provide an overview of the field to facilitate the ability to work in or lead project teams related to biopharmaceutical drug development. The course will focus on characteristics and complexities specific to the development of biopharmaceuticals. The focus will be on project initiation, discovery phase, including pharmacology and protein engineering. Particular emphasis will be given to pharmaceutical development and safety assessment of biopharmaceuticals. Regulatory aspects will be taught as well.

The days are split into two sessions: In the mornings, there will be lectures held by experts (industry, academia and authorities), who will introduce basic concepts and specific issues related to  biopharmaceuticals within their fields of expertise. In the afternoons, you will work on specific cases in small groups.

Participants

The course is aimed for professionals in the pharmaceutical industry who need an interdisciplinary overview of the specific requirements for development of biopharmaceuticals.

Participants should:

  • Hold a relevant bachelor degree or equivalent
  • Have a minimum of 2 years of relevant job experience within drug development
  • Be proficient in English

Course dates

5 days, 15 – 19 August 2016, 9:00 – 16:30 at the University of Copenhagen, Frederiksberg Campus, Bülowsvej 17, DK-1870 Frederiksberg, Denmark.

Course fee

EUR 2,600/DKK 19,000. Fee includes teaching, course materials, all meals during the course and examination.

109352| Faculty of Health and Medical Sciences, University of Copenhagen| Quality - Active Substance and Medicinal Product|

 Content

This course provides the students with a comprehensive overview of the quality related requirements and critical issues of the quality part of a registration dossier of a medicinal product with interfaces to product development and post approval maintenance. The various subjects range from chemical synthesis of active substances and development of medicinal products including QbD to global quality trends.
After completion of this course the student should be able to understand the basic principles of how to design, develop and document active substances and medicinal products i.e. how data are generated and how the work is regulated by guidelines and quality standards. Additionally, the student should be capable of analyzing and evaluating the development processes, reports, specifications, methods and data – all seen from a regulatory point of view.

Upon completion of the course you will be able to:


Knowledge

  •  Explain and discuss regulatory quality requirements and documentation in regards to medicinal product development.
  •  Explain and identify the basic principles of regulatory quality requirements and documentation and how this work is regulated through guidelines and standards.
  •  Explain and discuss how quality build into daily activities may improve performance and may result in faster submissions and approval

Skills

  •  Apply and analyse the development processes, reports, specifications, methods and data to ensure coherency and transparency of the quality dossier and compliance with required guidelines and quality standards
  •  Act in the chemistry, manufacturing and control (CMC) interface
  •  Analyse and discuss the CMC documentation in relation to the clinical phases

Competencies

  •  Make quality plans and take decisions with regard to pharmaceutical development

Dates:

  • 7-9/11 2016

Price:

  • DKK 19.975 for EU/EEA citizens
109351| Faculty of Health and Medical Sciences, University of Copenhagen| Regulatory Affairs in the USA|

Content

The course provides an in-depth overview of the US FDA organization, history, legal standing and roles and responsibilities in the new drug and biologics approval, registration, and marketing process.
Requirements and recommendations for interaction with the FDA are presented for each step in the drug and biologics submission process, including meeting requests, briefing materials and documentation, and dispute resolution. Technical and regulatory requirements for nonclinical, clinical, and chemistry and manufacturing portions of IND, NDA, BLA, and ANDA submissions are described, and the impact of key FDA Guidance documents explained.
Specific similarities and differences between the FDA and EMA are presented, especially major differences in technical requirements and regulatory authority, so that students understand the US FDA in the context of world-wide regulatory submissions. 

After completing the course the student is expected to be able to:

Knowledge

  • Understand the structure of the FDA and the legal basis for the FDA’s role in US drug regulation
  • Understand the requirements and deadlines for written and oral communication with the FDA from the pre-IND through post-approval stages of drug and biologics submissions
  • Understand the specific regulatory requirements (cGLP, cGCP, cGMP) for data that are submitted to the FDA
  • Understand how to use websites, especially FDA.gov, to research and retrieve important Guidance documents, legal action notices, and clinical trials information.
  • Understand key differences between FDA and EMA regulatory processes and requirements

Skills

  • Participate and lead teams in understanding and meeting FDA requirements for the study and registration of new drugs and biologics in the US
  • Prepare written meeting requests, draft questions, assemble background packages, and document interactions with the FDA
  • Advise teams on the impact of current and draft Guidance notices from the FDA, new US laws, and international (ICH) regulations on the study and registration of new drugs and biologics

Competencies

  • Explain the structure of FDA and areas of legal responsibility
  • Identify and apply correct timelines for written and verbal FDA interactions
  • Identify where and how key information can be found
  • Recognize key differences between FDA and EMA requirements

Dates:

  • 7-9/6 2017

Price:

  • DKK 19.975 for EU/EEA citizens
109350| Faculty of Health and Medical Sciences, University of Copenhagen| Regulatory Affairs in the EU|

Content

This course addresses the current and practical aspects of getting medicines approved in the EU. The student will obtain knowledge of the EU pharmaceutical legislation, the content of a marketing authorisation application (MAA), EU approval procedures, scientific advice from CHMP and national authorities, paediatric investigation plan, and orphan products, and Risk Management Plans.
After completion the student will be able to navigate in the approval procedures and
requirements for medicines in the EU, seek scientific advice from authorities and suggest and discuss reasonable pathways for obtaining approval for medicines (i.e. what is required of an MAA) in the EU.


After completing of the course the student is expected to be able to:

Knowledge

  •  Explain and discuss the EU regulatory framework and the various types of marketing authorisation applications (MAAs) for new medicinal products, generic and similar biological medicinal products, line extensions, variation applications and renewals
  •  Explain and discuss the Centralised Procedure (CP) and the Mutual Recognition Procedure /
  • Decentralised Procedure (MRP/DCP)
  •  Explain and discuss the needed content for a clinical trial application
  •  Explain and discuss the procedures for obtaining scientific advice
  •  Explain and discuss the orphan medicinal product designation
  •  Explain and discuss content and timing of the paediatric investigation plans
  •  Explain and discuss the content of risk management plans

Skills

  •  Analyse and consider the requirements for a MAA
  •  Identify, analyse and consider regulatory opportunities and consequences related to different types of products and submissions e.g. orphan medical products
  •  Comply with the EU requirement for paediatric investigation plans and risk management plans
  •  Analyse the overall strategic choices for the regulatory procedure used during development, application and maintenance of the medical product

Competencies

  •  Make strategic plans for applying for an MA and provide/obtain the needed documentation.

Dates:

  • 6-8/9 2016

Price:

  • DKK 19.975 for EU/EEA citizens
109348| Faculty of Health and Medical Sciences, University of Copenhagen| Global Medicines Legislation and Guidelines|

Content

The aim of the course is to illustrate and discuss the reasons for the highly detailed regulation that the development of medicines is subjected to, and how scientific knowledge (i.e. regulatoryscience) can be used to develop this legislation. The student will obtain knowledge on medicines authorities and global collaboration e.g. EMA, FDA, WHO and ICH, on the general law systems and legal framework for the medicines authorities as well as become able to account for the arguments for and against patenting, data protection and supplementary protection certificate (SPC) regulations. In addition, the differences between e.g. EU, US, Japan and BRIC countries in pharmaceutical legislation will be discussed, as well as a the interface between
medicines and e.g. medical devices.

Learning Outcome

After completion of the course the student will be able to:

  • Discuss regulation strategies for patenting, data exclusivity and supplementary protection certificate (SPC) regulations.
  • Analyze and discuss the background for different parts of the detailed regulation of medicines
  • Discuss the societal aspects of pharmaceutical legislation
  • Discuss how scientific knowledge (i.e. regulatory science) can be used to develop legislation of medicines.

Dates:

  • 27-28/2 + 6-7/3 2017

Price:

  • DKK 15.000
109347| Faculty of Health and Medical Sciences, University of Copenhagen| Discovery and Development of Medicines|

Why should you enroll in this course?

If you have a desire to get a comprehensive overview on how drugs are discovered and developed in the pharmaceutical industry today, you should join this course.  You will be faced with real examples from the industry and discuss problems and opportunities throughout the entire drug discovery and development process. If you are a young drug development professional or just need a brush-up course for continuing professional development (CPD) this is the course for you.

 

Participants will be able to convey an understanding of the dynamics of the drug development process, communicate and cooperate across research fields as well as identifying critical factors and bottlenecks that influence the discovery and development of medicines.

What do you gain?

On completion of the course, participants will have a comprehensive overview and understanding of drug discovery and development and a sound grasp of the fundamentals of the major implicated disciplines in order to:

  • Upon completion of this course you will understand the drug discovery and development process.
  • You will have learned how to identify correct professional terms and communicate professionally with the various specialist groups in the drug development industry.
  • You will be able to identify the important transition points and milestones for the progress that require involvement of authorities.
  • You will be able to plan a development process within the regulatory framework.

Combine state of the art industrial speakers with the best applied research, experience, and knowledge

We have assembled a unique team of industrial speakers, who are experts in the broad spectrum of activities involved in discovery and development of medicines. The course will cover both the theoretic background and give an industrial perspective on modern drug discovery and development.

Dates for next course: 4-8 January, 19-22 January and 25 January 2016

Price:

  • DKK 21,500 for EU/EEA citizens
  • DKK 25,220 for non-EU/EEA citizens
109344| Faculty of Health and Medical Sciences, University of Copenhagen| Clinical Development – Efficacy of Medicines|

Content

The student will obtain knowledge within the fields of clinical documentation needed to support global marketing authorisations. This includes:

  •  Understanding Good Clinical Practice (GCP)
  •  Documentation to be created through all phases of clinical development, from first studies in humans, exploratory studies, confirmatory studies and post marketing studies.
    Clinical study protocols, reporting study results, benefit-risk assessment, summaries of clinical data and product information ,specifically labelling of drugs, which makes up the clinical documentation submitted to health authorities for approval.
  • Regulatory strategy and interaction with health authorities to discuss the clinical development as part of the regulatory process to ensure a successful drug development.
  • The design of early studies, will discuss design of pharmacokinetic and pharmacodynamics studies. The course will discuss how early studies are conducted to best support the design of the confirmatory studies (i.e. phase III trials). The global nature of medicinal product development will be explained and used in model workshops.
  • Selection of the parameters to be investigated in clinical trials are an important part of drug development, and must be based on the objective of the trials. When these items are in place, the design can be outlined and analytical methodologies described.
  • Insight into statistical methodologies and different models for clinical trial design.

Upon completion the student will be able to provide regulatory input to clinical teams. The student will have an overall understanding of what clinical development consist of, and thereby contribute to clinical study teams, investigate the requirements for getting the studies authorised by authorities, interact with global regulators and eventually put together the clinical sections of a marketing authorisation application, create product information and vary the documentation during lifecycle of the medicinal product.

Learning Outcome

After completing the course the student is expected to be able to:

Knowledge

  • Explain and discuss the required clinical documentation for a marketing authorisation application (MAA)
  • Explain and identify the principles of clinical development from phase I to IV for both small molecules and biopharmaceuticals
  • Explain and discuss how clinical risk assessment can be handled during development

Skills

  • Create, analyse and evaluate a regulatory strategy plan for the clinical development of a new medicinal product
  • Evaluate the possibilities and consequences of the clinical development plan on the desired label

Competencies

  • Contribute to plans and proposals with regard to clinical development and documentation

Dates:

  • 7-10/3 2017

Price:

  • DKK 25.575 for EU/EEA citizens
109345| Faculty of Health and Medical Sciences, University of Copenhagen| Biopharmaceuticals - quality development and documentation|

Content

The aim of this course is to give attendees knowledge about the scientific background of
biotechnological products and the regulatory requirements to fulfil, in order to obtain approval of these types of medicinal products.

Attendees will get an understanding of the quality issues specific to biopharmaceuticals, for example; the generation of a recombinant microorganism, the expression of the product from the microorganisms and its purification, and the regulatory expectations for characterisation of a biopharmaceutical product and to release/stability specifications set for these types of products. As process changes are inevitable during development of a biological/biotechnological product this course will provide the implications of changes in the production process and elaborate the concept of comparability.

In addition to providing the students with a general understanding of specific quality issues for biopharmaceuticals, this course will focus on how to prepare regulatory CMC/Quality strategies and how to ensure compliance with regulatory requirements throughout the clinical development and post-approval processes. The discussions on CMC/Quality strategies will include both EU and FDA aspects, and the lectures will focus attention on both EU and FDA regulatory procedures for approval of biopharmaceuticals. Further, the course will guide the students through the structure of CMC/Quality sections for IND/CTA and BLA/MAA in the CTD format.

After completing the course the student is expected to be able to:

Knowledge

  •  Understand the basic principles of manufacturing biopharmaceuticals - from the recombinant starting material to the final product, including product characterization and setting specifications as well as the specific quality issues of biopharmaceuticals.
  •  Understand the critical parts of CMC/Quality sections of the submission file.
  •  Understand the regulatory expectations to meet in CMC/Quality documentation throughout the different phases of clinical development for approval of these types of medicinal products and for demonstration comparability during life cycle management.

Skills

  •  Evaluate and organise information provided by CMC/Quality stakeholders during product development and post-approval.
  •  Prepare regulatory CMC/Quality strategies, consider both FDA and EU aspects throughout the clinical development.
  •  Evaluate relevant regulations and guidelines for biopharmaceuticals.

Competencies

  •  Apply best practice in product characterisation and setting of release/stability specifications of a biopharmaceutical, including comparability issues related to manufacturing changes, when preparing a CMC/Quality meeting with Authorities, and when structuring the CMC/Quality sections for IND/CTA and BLA/MAA in the CTD format.

Dates:

  • 7-9/11 2016

Price:

  • DKK 19,975 for EU/EEA citizens.
109342| Faculty of Health and Medical Sciences, University of Copenhagen| Clinical Course at a Specialized Headache Center|

Content

The course will present you for real life patients and teach you how to obtain the correct diagnosis, how to interview and inform patients, how to make an optimal management plan and how to follow up on these patients. All aspects including the role of physiotherapists, nurses, secretaries and psychologists will be covered and you will get hands on experience with injections of botolinum toxin and greater occipital nerve blockades.
The course is organized as a combination of hands on management of patients and lectures, which will be mainly cased based. The course will include homework, where you will have to prepare clinically oriented presentations. At the end you will have learned how a multidisciplinary tertiary headache centre managing complex headache patients is organized and how to put previously acquired theory into practice.

The course covers the following topics:

• participation in patient interviews,
• examinations,
• follow up-visits,
• prevention strategies
• interdisciplinary treatments as well as
• patient communication
• instructions and strategic discussions with patients and relatives
• case demonstrations
• lectures and clinical training in a pediatric headache center
• hands-on demonstration and practise of injections of botulinum toxin
• hands-on demonstration and practise of greater occipital nerve blockades

Teaching and learning methods

The teaching methods will include a combination of interactive lectures, patient interviews and presentations, hands-on-classes, group exercises, case studies, journal clubs, essay and computer-based (electronic) learning exercises (WIKIs). Using the Absalon platform or similar for upload of learning materials will allow team work for reading, interpreting and discussing selected scientific articles and cases.

Price:

  • DKK 15,000 for EU/EEA citizens
  • 22,170 for non-EU/EEA citizens
109341| Faculty of Health and Medical Sciences, University of Copenhagen| Organization of Headache Care and Clinical Practice|

Content

The course will cover the background for the present global organization of headache service. It will discuss pro- et con for the various service models and its applicability in the clinic and in various health care systems. The service for specific groups as children, the elderly and patients with severe comorbid conditions will also be covered. The strategies and existing evidence for the individual elements of a multidisciplinary headache clinic will be presented and discussed. Research methods, study planning and organization of new clinical studies and protocols for clinical trials will be presented in lectures and discussed in groups. The students will be  encouraged to present and plan new studies and will be assisted with feed back to their protocols and strategies from the other students and the lecturers.

The course covers the following topics:

  • multidisciplinary and interdisciplinary treatment,
  • the care of hospitalised headache patients,
  • outpatient treatment,
  • biofeedback,
  • psychological treatment strategies,
  • physical therapy,
  • organising and participating in clinical treatment trials,
  • research projects and strategies
  • establish research networks.

Teaching and learning methods

The teaching methods will include a combination of interactive lectures, group exercises, case studies, journal clubs, essay and computer-based (electronic) learning exercises (WIKIs). Using the Canvass platform or similar for upload of learning materials will allow team work for reading, interpreting and discussing selected scientific articles and cases.

What do you gain?

On completion of the course, the participants should be able to:

Knowledge:

  • have insight into existing interdisciplinary treatment options for both inpatients and outpatients.
  • have knowledge about the present organisation of headache treatment, research strategies and international network groups.

Skills:

  • make an optimal assessments and selection of treatment options for the individual patient, to choose a correct combination of pharmacological and non-pharmacological treatment and to select the right patients for neuromodulation treatment.
  • follow patients with severe symptoms over a longer time period and adjust treatment optimally with consideration for the resources available
  • assess and critically discuss scientific articles on multidisciplinary and non-pharmacological treatment.

Competencies:

  • make relevant selections and optimise the available treatment process, contribute to the future development of new treatments on a scientific basis, as well as initiate new treatment studies.
  • initiate or contribute to establishing new research networks and collaborations.

Price:

  • DKK 10,000 for EU/EEA citizens
  • DKK 15,378 for non-EU/EEA citizens
109340| Faculty of Health and Medical Sciences, University of Copenhagen| Mechanisms and Comorbidities of Headache and Facial Pain|

Content

This course will focus on complex pathophysiological mechanisms underlying headache and facial pain disorders, and the role of comorbidities in neurobiology of headache disorders.

We will cover the most important theories/hypotheses, discovery in genetics, strengths and limitations of animal and human studies, animal models of secondary headaches. The questions addressed will include: What can we learn from headache genetics? What have we learned from headache provocation studies in patients? Can we use brain imaging to discover specific biomarkers of headache disorders? What do we know about mechanisms of action of currently available drugs? What is pathophysiological rationale for using neurostimulation in the treatment of headache disorders? What are molecular mechanisms of mild head injury and medication overuse headache?

The course is organized as a combination of face-face lectures, group work, case studies, and journal clubs provided and supervised by the world leading specialists in the field. As the Master Program is planned as a part time study, a significant part of the work load is required to be carried out as home work with blended learning and the reading of literature in between the modules.  A personal mentor will be appointed to each student and there will be provided possibilities for platform based discussion fora between the students and in relation to their mentors.

The course covers the following topics:

  • Genetics of headache disorders
  • Physiology and the disease mechanisms of :
    • migraine headaches
    • tension-type headaches,
    • cluster headaches and other trigeminal autonomic headaches.
    • medication overuse headache
    • idiopathic intracranial hypo- and hypertension
    • posttraumatic headache
    • other secondary headaches
    • trigeminal neuralgia and other cranial neuralgias.
  • Comorbidity and disease interaction.
  • Experimental human and animal models for headache and facial pain. 

what do you gain?

On completion of the course, the participants should be able to:

Knowledge:

  • gain detailed insights into the existing knowledge about underlying genetic and pathophysiological mechanisms of primary and secondary headache disorders as well as facial pain.
  • acquire knowledge about the mechanisms underlying the most common comorbid conditions for headache disorders and their relevance to disease development and treatment.
  • acquire knowledge about existing in vitro and in vivo experimental headache models.

Skills:

  • learn to understand, discuss and critically assess the scientific literature in the area of genetics and disease mechanisms.
  • communicate this knowledge to patients and their families, as well as to their own colleagues, based on a well-balanced scientific background.
  • develope a basis for understanding the examination and treatment strategies through insight into disease mechanisms and comorbidity

Competencies:

  • acquire the prerequisites for participating in or initiating new scientific investigations of disease mechanisms and treatment
  • optimise the treatment process and contribute to a critical assessment of new treatment strategies on a scientific basis.

Price:

  • DKK 10,000 for EU/EEA citizens
  • DKK 15,678 for non-EU/EEA citizens
109338| Faculty of Health and Medical Sciences, University of Copenhagen| Investigations and Management of Headache and Facial Pain|

Content

The content of the course is structured to develop your understanding of the imaging methods and other laboratory tests that are used in the work-up of primary headache diagnosis or when suspecting a secondary headache condition. We will also cover laboratory tests that may be used to subcategorize primary headaches. The course will describe the treatment principles and strategies for primary headaches and trigeminal neuralgia and other cranial neuralgias. Treatment principles of medication-overuse headache, idiopathic intracranial hypertension and other important secondary headache will also be covered.  Treatment modalities that are covered include non-pharmaceutical, pharmaceutical, neurostimulation and neurosurgical procedures. Novel treatment modalities and future development will also be covered.

The course is organized as a combination of face-face lectures, group work, case studies, and journal clubs provided and supervised by the world leading specialists in the field. As the Master Program is planned as a part time study, a significant part of the work load is required to be carried out as home work with blended learning and the reading of literature in between the modules.  A personal mentor will be appointed to each student and there will be provided possibilities for platform based discussion fora between the students and in relation to their mentors.

The course covers the following topics:

  • Neuroimaging
  • Neurophysiology
  • Quantitative sensory testing (QST) and other examination modalities
  • CSF pressure
  • Treatment principles and opportunities for acute and preventive treatment of:
  • Migraine headaches
  • Tension-type headaches
  • trigeminal neuralgia and other cranial neuralgias
  • cluster headaches and other trigeminal autonomic cephalalgias
  • medication-overuse headache
  • Secondary types of headache.

What do you gain?

On completion of the course, the participants should be able to:

  • acquire knowledge and insight into existing and new examination methods, relevance for the individual patient, sources of error and opportunities.
  • gain knowledge on the highest international level about basic and clinical pharmacology, the background for medical treatment and the correct use of medicine for headache patients.
  • review the operative intervention in trigeminal neuralgia and use of neuromodulation for acute and preventive treatment for primary headache types.

Skills:

  • learn how to set an optimal and relevant programme of examination for all the primary and secondary types of headache and facial pain. Consideration will be made for various international healthcare systems and optimal use of available resources.
  • initiate and maintain optimal treatment in the acute phase as well as prevention, and learn how to assess and adjust treatment response over time.
  • assess and critically discuss scientific articles about examinations and treatment.

Competencies:

  • optimise diagnostic reports and contribute to the future development and validation of new diagnostic initiatives.
  • perform, initiate and participate in new types of treatment on a scientific basis, to initiate new types of examination
  • help and develop national and international treatment guidelines.

Price

  • DKK 10,000 for EU/EEA citizens
  • DKK 15,378 for non-EU/EEA citizens
109339| Faculty of Health and Medical Sciences, University of Copenhagen| Epidemiology and Diagnosis of Headache and Facial Pain|

Content

The content of the course has been chosen and structured to develop your understanding of the epidemiology and global burden of headache as well as diagnosis and clinical features of headache disorders. The course will provide you with an introduction to headache as a collection of complex neurological disorders that impact significantly as a patient and societal burden. Epidemiological studies will be selected for detailed methodological discussions and strengths and limitations will be emphazised.

It will also cover the background for and the organization of the ICHD-3 classification system and its use and applicability in the clinical setting. Headache in children, in the elderly and in relation to hormones and pregnancy will be covered as well as headache in the emergency room and the possible differential diagnosis and comorbidities. The complex headache patient will be discussed especially in relation to the variation of secondary headaches.

Teaching and learning methods

The First four weeks is a part-time online course with online lessons, discussions and quizzes and self-study activities. It will be followed by a week of full-time lectures, discussions, group work, and exercises in Copenhagen.
The teaching methods will include a combination of interactive lectures, group exercises, case studies, journal clubs, essay and computer-based (electronic) learning exercises (WIKIs). Using the KU Canvass platform or similar for upload of learning materials will allow team work for reading, interpreting and discussing selected scientific articles and cases.

Topics

The course covers the following topics :

- Epidemiology
- Headache classification.
- Clinical presentation.
- Primary headache types.
- Painful cranial neuropathies.
- Secondary headache types including acute headaches.
- Headache in children, the elderly and pregnant women.
- Differential diagnoses.
- Societal perspectives and social consequences of headache.
- General health implication and prevention of headache disability.

What will you gain?

On completion of the course, the participants should be able to:

Knowledge

  • gain insight into the International Classification of Headache Disorders and acquire detailed knowledge about the clinical presentation of several headache types and painful cranial neuropathies.
  • acquire knowledge about the most commonly occurring comorbid conditions associated with headache disorders and certain patient categories.
  • gain insight into headache epidemiology, the consequences of headache disorders on an individual and societal level, as well as initiatives for prevention.

Skills:

  • learn to make the optimal headache diagnoses,  to use and analyze a headache diary correctly and to assess relevant differential diagnoses for the individual patient.
  • critically assess and discuss scientific articles about epidemiology and social consequences as well as prevention strategies.

Competencies:

  • have the opportunity to optimise the diagnostic process, contribute to future revision of the classification system on a scientific basis, initiate new epidemiological studies and develop relevant prevention strategies.

Price:

  • DKK 10,000 for EU/EAA citizens
  • DKK 15,378 for non-EU/EAA citizens
109335| Multiple Locations| Pain Management: Advanced Study Day|

?This one day study course will include  assessment and diagnosis of Spinal pain and  Surgical interventions. It also include pain diagnosis and management.

 Learning Outcomes:

          After attending this study day, participant will develop:-

1. Advanced learning for diagnosis and surgical intervention of spinal pain

2. In-depth understanding of Pain

3.- Develop advanced clinical reasoning skills

4- Develop problem solving skills.

109336| Multiple Locations| Pain Management: Advanced Study Day|

?This one day study course will include  assessment and diagnosis of Spinal pain and  Surgical interventions. It also include pain diagnosis and management.

 Learning Outcomes:

          After attending this study day, participant will develop:-

1. Advanced learning for diagnosis and surgical intervention of spinal pain

2. In-depth understanding of Pain

3.- Develop advanced clinical reasoning skills

4- Develop problem solving skills.

109334| EuroSciCon Ltd| Parasitic Infection 2016|

In an academic setting, this event will focus on the current research into parasitic infection and disease. Over three days, this international summit will cover recent research and developments relating to diagnosis, treatment and drug design. Parasitic infections including malaria and neglected diseases, such as trypanosomiasis, will be discussed in detail, as well as discussion about methods of eradication.

109333| EuroSciCon Ltd| TB Summit 2016|

This annual three day event will explore new research into TB detection, treatment and vaccination as well as new developments in controlling and preventing Mycobacterium tuberculosis Infection.
With an informal academic atmosphere and international speakers, it is the perfect environment for debate and discussion.

109332| EuroSciCon Ltd| The 2016 Alzheimer's Disease Congress|

This three day international academic congress will discuss current research and treatments being developed for Alzheimer’s Disease. Topics for discussion include prediction and prevention strategies, vaccine development, drug discovery and care. With plenty of opportunity for networking and debate, this informal international meeting will bring you up to date with current research and thinking regarding Alzheimer’s Disease.

109325| Multiple Locations| Course "Why is FDA at my Facility, and What do I do During an Inspection"|

Course "Why is FDA at my Facility, and What do I do During an Inspection" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483's and Warning Letters. Emphasis is placed on the company's SOP on dealing with inspectors and knowing how to be prepared, proactive...and being able to defend and justify... and what it takes to achieve a favorable outcome. This seminar provides background and understanding of the role played by the Agency, its administrative and enforcement powers. It takes the participant step by step through the entire inspection process and describes various types of inspections.

Who will benefit:

Industries

  • FDA regulated Industries
    • Medical Device
    • Pharmaceuticals
    • Clinical
  • Dietary Supplements
    • Food
    • Nutraceutical
  • Healthcare IT
    • Technical Services
    • Validation
    • Engineering

Departments

  • Top and Middle Management
  • Quality Assurance/Management
  • Compliance Management
  • Manufacturing
  • Laboratory
  • Regulatory Affairs
  • Information Technology
  • Marketing & Sales
  • Operations
  • Research & Development

Types of facilities:

  • Manufacturing facilities
  • Contract manufacturing facilities
  • Distributors
  • Packaging, Labeling
  • API Suppliers
  • Laboratories
  • Importers
  • Documentation Management

Agenda:

Day 1 Schedule

Lecture 1:

How a firm should prepare for an FDA inspection

Lecture 2:

Ways to train employees in view of the inspection

Lecture 3:

How to ensure that required documentation is in place

Lecture 4:

How to interact with the investigator-DO's and DON'T's

Lecture 5:

What companies should do when the inspection ends

Lecture 6:

How to reply to 483's and warning letters

Lecture 7:

Legal implications of non-compliance

Lecture 8:

Post inspection actions

Day 2 Schedule

Lecture 1:

Why inspections are conducted and by what statutory authority

Lecture 2:

The emphasis on systems-based inspections...and the IOM and other crucial FDA reference documents

Lecture 3:

What is subject to FDA purview and what's off-limits

Lecture 4:

Understand and apply the do's and don'ts and comprehend that preparation is the key to success

Lecture 5:

What are the prohibited "Acts" and the enforcement categories that you need to deal with

Lecture 6:

What you need to know and do to prepare for, during and even after the inspection...and why your inspection response team is key

Lecture 7:

The company's Inspection Plan (SOP) can make or break the inspection depending on how to use it and training your personnel

Lecture 8:

How to respond to findings and facilitating the documentation and remediation process...and reaching final closure

Lecture 9:

Define clear responsibilities, roles and goals for personnel involved in SOP development

Speaker:

David R Dills

Regulatory Affairs & Compliance Consultant,

David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements. Background encompasses broad capabilities in quality systems, validation, regulatory affairs, compliance, auditing, interfacing with the regulatory agencies, addressing enforcement actions and mitigating compliance exposure for companies via remediation, compliance engineering support, post-marketing surveillance and vigilance reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP compliance; preparation for ISO 13485 registration and CE Mark; and multi-country product registrations and licensing; and working with Notified Bodies, and AR's. David manages regulatory problems (e.g. AE's, MDRs, Agency enforcement, complaints/investigations, field alerts/recalls) related to development, manufacturing, and commercialization, and recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. This is based on analyzing the benefits/risks for informed decision-making and interprets the regulatory precedents and new legislation. He strives to optimize business performance through proactive strategies to mitigate compliance exposure by providing strategic and tactical solutions that facilitate the achievement of regulatory and quality milestones. David has been previously affiliated with well-known device manufacturers and service providers, including a global CRO and has served in various quality, regulatory and compliance management and advisory capacities with increasing responsibilities. David is an industry speaker and author of technical and compliance related topics published in industry journals. Please refer to his profile provided herein for additional information about his background and areas of interest and focus.

Location: Singapore Date: July 18th & 19th, 2016 and Time: 9:00 AM to 6:00 PM

 

Venue: WILL BE ANNOUNCED SOON

Address: 18 Salisbury Road, Kowloon, Singapore

 

Price:

 

Register now and save $200. (Early Bird)

 

Price: $1,695.00 (Seminar Fee for One Delegate – Without stay)

 

Until June 20, Early Bird Price: $1,695.00 from June 21 to July 16, Regular Price: $1,895.00

Price: $2,095.00 (Seminar Fee for One Delegate - With stay)

 

Until June 20, Early Bird Price: $2,095.00 from June 21 to July 16, Regular Price: $2,295.00

Quick Contact:

NetZealous DBA as GlobalCompliancePanel

 

Phone: 1-800-447-9407

Fax: 302-288-6884

Email: support@globalcompliancepanel.com      

Website: http://www.globalcompliancepanel.com

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900547SEMINAR      

Follow on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel

 

 

 

 

 

 

 

 

109326| Multiple Locations| Course "Why is FDA at my Facility, and What do I do During an Inspection"|

Course "Why is FDA at my Facility, and What do I do During an Inspection" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483's and Warning Letters. Emphasis is placed on the company's SOP on dealing with inspectors and knowing how to be prepared, proactive...and being able to defend and justify... and what it takes to achieve a favorable outcome. This seminar provides background and understanding of the role played by the Agency, its administrative and enforcement powers. It takes the participant step by step through the entire inspection process and describes various types of inspections.

Who will benefit:

Industries

  • FDA regulated Industries
    • Medical Device
    • Pharmaceuticals
    • Clinical
  • Dietary Supplements
    • Food
    • Nutraceutical
  • Healthcare IT
    • Technical Services
    • Validation
    • Engineering

Departments

  • Top and Middle Management
  • Quality Assurance/Management
  • Compliance Management
  • Manufacturing
  • Laboratory
  • Regulatory Affairs
  • Information Technology
  • Marketing & Sales
  • Operations
  • Research & Development

Types of facilities:

  • Manufacturing facilities
  • Contract manufacturing facilities
  • Distributors
  • Packaging, Labeling
  • API Suppliers
  • Laboratories
  • Importers
  • Documentation Management

Agenda:

Day 1 Schedule

Lecture 1:

How a firm should prepare for an FDA inspection

Lecture 2:

Ways to train employees in view of the inspection

Lecture 3:

How to ensure that required documentation is in place

Lecture 4:

How to interact with the investigator-DO's and DON'T's

Lecture 5:

What companies should do when the inspection ends

Lecture 6:

How to reply to 483's and warning letters

Lecture 7:

Legal implications of non-compliance

Lecture 8:

Post inspection actions

Day 2 Schedule

Lecture 1:

Why inspections are conducted and by what statutory authority

Lecture 2:

The emphasis on systems-based inspections...and the IOM and other crucial FDA reference documents

Lecture 3:

What is subject to FDA purview and what's off-limits

Lecture 4:

Understand and apply the do's and don'ts and comprehend that preparation is the key to success

Lecture 5:

What are the prohibited "Acts" and the enforcement categories that you need to deal with

Lecture 6:

What you need to know and do to prepare for, during and even after the inspection...and why your inspection response team is key

Lecture 7:

The company's Inspection Plan (SOP) can make or break the inspection depending on how to use it and training your personnel

Lecture 8:

How to respond to findings and facilitating the documentation and remediation process...and reaching final closure

Lecture 9:

Define clear responsibilities, roles and goals for personnel involved in SOP development

Speaker:

David R Dills

Regulatory Affairs & Compliance Consultant,

David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements. Background encompasses broad capabilities in quality systems, validation, regulatory affairs, compliance, auditing, interfacing with the regulatory agencies, addressing enforcement actions and mitigating compliance exposure for companies via remediation, compliance engineering support, post-marketing surveillance and vigilance reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP compliance; preparation for ISO 13485 registration and CE Mark; and multi-country product registrations and licensing; and working with Notified Bodies, and AR's. David manages regulatory problems (e.g. AE's, MDRs, Agency enforcement, complaints/investigations, field alerts/recalls) related to development, manufacturing, and commercialization, and recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. This is based on analyzing the benefits/risks for informed decision-making and interprets the regulatory precedents and new legislation. He strives to optimize business performance through proactive strategies to mitigate compliance exposure by providing strategic and tactical solutions that facilitate the achievement of regulatory and quality milestones. David has been previously affiliated with well-known device manufacturers and service providers, including a global CRO and has served in various quality, regulatory and compliance management and advisory capacities with increasing responsibilities. David is an industry speaker and author of technical and compliance related topics published in industry journals. Please refer to his profile provided herein for additional information about his background and areas of interest and focus.

Location: Singapore Date: July 18th & 19th, 2016 and Time: 9:00 AM to 6:00 PM

 

Venue: WILL BE ANNOUNCED SOON

Address: 18 Salisbury Road, Kowloon, Singapore

 

Price:

 

Register now and save $200. (Early Bird)

 

Price: $1,695.00 (Seminar Fee for One Delegate – Without stay)

 

Until June 20, Early Bird Price: $1,695.00 from June 21 to July 16, Regular Price: $1,895.00

Price: $2,095.00 (Seminar Fee for One Delegate - With stay)

 

Until June 20, Early Bird Price: $2,095.00 from June 21 to July 16, Regular Price: $2,295.00

Quick Contact:

NetZealous DBA as GlobalCompliancePanel

 

Phone: 1-800-447-9407

Fax: 302-288-6884

Email: support@globalcompliancepanel.com      

Website: http://www.globalcompliancepanel.com

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900547SEMINAR      

Follow on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel

 

 

 

 

 

 

 

 

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