Course "New Clinical Trials Regulation of Medicinal Product Development in the EU" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Course Description:

This in-person training program on the new Clinical Trials Regulation and regulatory affairs aspects of medicinal product development in the EU will discuss:

  • All regulatory aspects to ensure a smooth development, including how to obtain orphan medicinal product status from the EMA, as well as when to ask for scientific advice.
  • How to integrate paediatric studies in the development plan and information regarding the special regulatory aspects of advanced therapy medicinal products and oncology medicinal products.
  • The current system for clinical trials applications in the EU as well as the changes under the new Clinical Trials Regulation.
  • How to avoid the current situation where a common protocol is proposed in all EU Member States that participate in a clinical trial but requests for amendments may result in country-specific changes that require subsequent amendments in other countries to maintain a common protocol.
  • How the new regulation will change the way pharmaceutical companies handle the clinical trial approval process.
  • Timelines for companies to start preparing for these changes and implementations to allow optimal preparation.

Learning Objectives:

Upon completion of this course, each participant will have a comprehensive knowledge and understanding of development regulatory affairs. Participants will have learned the following:

  • How to create a comprehensive regulatory plan
  • How to obtain orphan medicinal product status from the EMA
  • When to ask for scientific advice and how to do this
  • How and when to integrate paediatric studies in the development plan
  • What are the special regulatory aspects of advanced therapy medicinal products and oncology medicinal products
  • How the clinical trial approval process in the EU works and how this will change

Who will Benefit:

This course is specifically designed for:

  • Regulatory affairs officers and managers
  • Clinical trial associates
  • Clinical operations personnel
  • Personnel in the pharmaceutical and biotech industries who need a thorough understanding of the regulatory issues involved in the development of new medicinal products within the European Union
  • Individuals who are seeking to update their knowledge of recent regulatory changes and their impact on product development

Topic Background:

In the current situation, a common protocol is proposed in all EU Member States that participate in a clinical trial but requests for amendments may result in country-specific changes that require subsequent amendments in other countries to maintain a common protocol. The new regulation will change the way pharmaceutical companies handle the clinical trial approval process, and companies need to start preparing for these changes and practices now. It is important to know the new procedures for approval of clinical trials to avoid delays and minimize the time for approval.

Course Outline:

Day 1 (8:30 AM – 4:30 PM) Day 2 (8:30 AM – 4:30 PM)
  • 8:30 – 9:00 AM: Registration
  • 9:00 AM: Session Start Time
  1. Introductions and Agenda Review
    • Elements of development regulatory affairs
    • The regulatory plan
    • Overview of the EMA
  2. Regulatory Strategy and Regulatory Plans (Including Target SmPC)
    • Structure of the regulatory plan
    • Sources for the regulatory plan
  3. Pricing and Reimbursement
    • What is HTA?
    • HTA bodies
  4. Scientific Advice
    • Topics for scientific advice
    • Briefing document
    • National versus EMA
  5. Orphan Medicinal Products
    • What are orphan medicinal products?
    • Main incentives
    • Applying for orphan medicinal product designation
  6. Paediatric Development
    • Paediatric investigation plans
    • Waivers/deferrals
    • PUMA
  7. Advanced Therapy Medicinal Products
    • Definitions
    • Certification procedure
    • Guidelines
    • Practical exercise: Determine for various products if they fall under the ATMP definition
  1. Oncology
    • Why is development of oncology products different?
    • Preclinical considerations
    • The new clinical oncology guideline
  2. SME Status
    • Advantages of SME status
    • How to apply for SME status
  3. Practical Session: Regulatory Plan
    • Case study: New oncology product
    • Does it qualify for orphan drug designation?
    • How to propose the optimal orphan indication
    • Paediatric studies necessary?
    • Scientific advice: Topics, selection of authorities
  4. How to Apply for a Clinical Trial Authorisation in the EU
    • The clinical trial directive
    • Outline of the procedure
    • Content of the IMPD and important guidance documents
  5. Voluntary Harmonisation Procedure
    • Overview of the process
    • Advantages and disadvantages
  6. Future Changes to the Clinical Trial Authorisation Process in the EU
    • The Clinical Trial Regulation
    • Impact on the pharmaceutical and biotech industry
  7. Questions

Meet Your Instructor

Adriaan Fruijtier
Regulatory Affairs Consultant

Adriaan Fruijtier graduated as a pharmacist from the University of Utrecht, Netherlands. Until March 2004, he headed the oncology group within global regulatory affairs at Bayer AG, Wuppertal, Germany, and Bayer Corporation, West Haven, CT, USA. Between 2001 and 2003, he was director of regulatory affairs at Micromet AG, a biotech company in Munich, Germany. Prior to joining Micromet, he served as a project manager for oncology projects at the European Medicines Agency for four years in London.

He joined the European Medicines Agency from Novartis AG, Basel, Switzerland, where he was regulatory affairs project manager in the oncology group between 1996 and 1997. Before 1996, he was head of drug regulatory affairs for six years at Ciba-Geigy in the Netherlands, and has worked as manager regulatory affairs at Glaxo, also in the Netherlands.

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