Webcast Series: Legal Issues in Regulatory Affairs
Regulatory & legal interface to other departments

09:00 CET

Referrals - preparation and procedure

  • Referral procedure from a legal point of view - PV triggered and others
  • Duties of the pharmaceutical company
  • How to stay informed as a generics company

Contracting in regulatory affairs

  • Legal aspects of dossier purchase and licencing
  • Outsourcing regulatory affairs activities
  • Regulatory affairs aspects: change of marketing authorisation holder


FORUM Institut für Management GmbH

Sträter Lawyers
Kronprinzenstraße 20
D-53173 Bonn

Fon +49 (0) 228 93454-0
Fax +49 (0) 228 93454-54



Prof. Burkhard Sträter

Prof. Burkhard Sträter founded the law firm in 1987 and systematically concentrated on the areas of specialisation. He is an honorary professor at the University of Bonn and leads the Master of Drug Regulatory Affairs (MDRA) course,