EU Regulatory Affairs Introductory Training Course

Detailed programme

Day 1-3: 09:00-17:00 online-seminar
The times for breaks at online-seminars are scheduled individually.

09:00

Kora Doorduyn-van der Stoep

Basic principles and terminology

• The regulatory framework: regulations, directives and guidelines
• Involved authorities
• The available marketing authorisation procedures: centralised, decentralised and national

10:15

Dr Christian M. Moers

Legal basis for marketing authorisation procedures in Europe

• Full application, bibliographic application, mixed application and informed consent
• Generic application, hybrid application and biosimilars
• Registration

11:00 Coffee break

11:15

Kora Doorduyn-van der Stoep

Mutual recognition and decentralised procedures

• Common principles
• Submission strategy
• Deadlines and clock stops

12:45 Lunch

13:45

Dr Maren von Fritschen

Centralised Procedure

• Scope and mandatory products
• Roles of the European Medicines Agency (EMA), the Committee for Medicinal Products for Human Use (CHMP) and national authorities
• The procedure in detail

15:00 Coffee break

15:15

Dr Christian M Moers

Pharmacovigilance requirements for marketing authorisation applications

16:15

Kora Doorduyn-van der Stoep

Specifics for generics

• Data exclusivity and innovation protection
• European reference product

17:00 End of Day 1

09:00

Aimad Torqui

Marketing authorisation dossier - Module 1

• Cover letter, application form, etc.
• National peculiarities

10:45

Aimad Torqui

SmPC and the package leaflet

• Key elements and structure of the SmPC and the package leaflet
• QRD templates
• Educational material

11:45

Aimad Torqui

Excursus: Specifics for Conditional Approval, PRIME, etc

12:15 Lunch

13:15

TBA

Module 4 and 5

• Compilation of preclinical and clinical data
• How to present study reports
• Common errors and authority findings

14:00

TBA

Module 2

• Common principles for overviews and summaries
• Practical examples

15:00 Coffee break

15:15

Jan-Jaap Scherpbier

CMC Module 3

• Core documents and data
• Common errors and authority findings
• Practical exercises

17:00 End of Day 2

09:00 Beginning of Day 3

09:00

Francijn Oom

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