European Union Regulatory Issues – New Product Development™

Available Locations


Course Description

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.

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.