Industries: Pharma / Biotech

European Union Regulatory Issues – New Product Development™

Course Director: Adriaan Fruijtier, M.Sc.

Course Description - Course runs 9:00 to 5:00 both days

This two-day course is designed to provide individuals with a detailed understanding of the important regulatory guidelines involved in the development of a new product plan within the EU. The program will also cover effective strategies for correctly applying the current regulations to ensure that rejections are avoided.

The course will provide the attendee with a thorough knowledge of the following topics:

  • How to develop a regulatory strategy
  • How to deal with pricing and reimbursement issues in your development
  • How to validate your regulatory strategy (scientific advice) and how to choose between centralized and national scientific advice
  • When does your product qualify as an orphan medicinal product and what are the advantages if it does?
  • How to deal with pediatric development plans
  • What has to be considered for Advanced Therapy Medicinal Product and oncology medicinal products

Who Should Attend

Attendance will be beneficial to personnel involved in new product development who need a thorough understanding of the issues affecting new medicinal products within the regulatory framework of the European Union.

The program will be useful to individuals who are seeking to update their knowledge of recent EMA regulatory changes and the impact these changes will have on the product development cycle.

First Day

Introductions & Agenda Review

  • What are the elements of development regulatory affairs?
  • How are these elements integrated in the regulatory plan?
  • Overview of the "Human Medicines Special Areas" Sector at the EMA

Regulatory strategy and regulatory plans (including target SmPC)

  • Structure of the regulatory plan
  • Sources for the regulatory plan
  • Key Milestones with timelines

Pricing and reimbursement

  • What is HTA?
  • HTA bodies

Scientific advice

  • Topics for scientific advice
  • Briefing document
  • National versus EMA

Orphan medicinal products

  • What are orphan medicinal products?
  • Main incentives
  • Applying for orphan medicinal product designation

Advanced Therapy Medicinal Products

  • Definitions
  • Certification procedure
  • Guidelines

Pediatric Development

  • Paediatric investigation plans
  • Waivers/deferrals
  • PUMA

Recap, Questions and Answers

Second Day


  • Why is development of oncology products different?
  • Preclinical considerations
  • The new clinical oncology guideline

SME status

  • Advantages of SME status
  • How to apply for SME status

Practical session

  • 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

Recap, Questions and Answers

  • Overview of the elements of development regulatory affairs and how they are related
  • Timing of each element

Learning Objectives

Those completing this course will have a comprehensive overview regarding all aspects of regulatory affairs as they relate to product development issues within the EU.

Participants will be able to create a comprehensive regulatory plan including how to obtain orphan medicinal product status from the EMA, as well as when to ask for scientific advice.

Additionally, the topic of how to integrate paediatric studies in the development plan will be discussed along with information regarding the special regulatory aspects of Advanced Therapy Medicinal Products and Oncology Medicinal Products.