Master's Course "Drug Regulatory Affairs"

Study Modules

Modul 05 (WS 2017 / SS 2018)

Pharmacovigilance / Maintenance of marketing authorisations

attendance approx. Seminar Paper Method of examination Credit
approx. 30 h approx. 30 h seminar paper and written examination 6

Module Supervisor

  • Prof. Dr. Barbara Sickmüller, Berlin
  • Dr. Michael Horn, Bonn

Topics

Part 1 - Pharmacovigilance
  • Pharmacovigilance planning and evaluation during the post-authorization period
  • Step Plan procedure (national / EU-wide)
  • ADR reporting procedures (national / EU-wide)
Part 2 - Maintaining marketing authorization: formal aspects
  • Application for extending marketing authorization
  • Renewal of marketing authorization as per § 31 AMG (German Drug Law)
  • Renewal of registration as per § 39 AMG
  • Application form
  • Attachments to the application form
  • Deadlines according to the German Drug Law
  • Failure to meet deadlines
  • Legal options if a deadline is missed
  • Harmonization of renewal data (common renewal date) national / EU
  • Decision by authority
  • Imposed conditions
  • Grounds for denial
  • Legal options in the case of a rejection
  • Significance of the Federal Gazette
  • EU procedures: renewal: MRP (CMS/RMS), centralized procedure
  • Traditional pharmaceutical products
  • Homeopathic products
Authorization-maintaining measures
  • Notices of variation / Variations
  • Updating the regulatory dossier
 

Study plan

Part 1 Pharmacovigilance:
Friday   02 February 2018 from 8.30 a.m. – 6.30 p.m.
Saturday   03 February 2018 from 8.00 a.m. – 4.00 p.m.
Location:    Uni-Club
Part 2 Maintaining of marketing authorization:
Friday   16 February 2018 from 8.30 a.m. – 6.30 p.m.
Saturday   17 February 2018 from 8.00 a.m. – 4.00 p.m.
Location   Uni-Club
     
    Deadline seminar paper: 03 April 2018

DocumentationOnly for members

Please login to your account.