The EU Regulatory Environment – Procedures and Applications

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 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 during life cycle management, development, application and maintenace of the medical product

• Prepare written meeting requests, draft questions, assemble background package, and documents for and be the interface in the interaction with EMA

Competencies

• Participate and lead international teams in understanding and meeting EU regulators requirements for the study and registration of new products in the EU

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

• Evaluate and propose strategic scenarious on different regulatory pathways for various EU situations

• Adivise teams on the impact of current and draft legislation and guidelines for the EMA, the european commission and international (ICH) guidelines on medicines