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        Study plan (MDRA-26) Study modules (MDRA-26) Study modules (MDRA-25) Internship Master's thesis Lecturer Literature
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In your studies 'Drug Regulator Affairs'

©Frank Luerweg / Universität Bonn

Study modules 

MDRA-26 (academic year 2024/2025)

Module 5 Maintenance of Marketing Authorisations / Pharmacovigilance

Monitoring during use, advertising, product changes, amendment and renewal of authorisation

  • Overview
  • 1
  • 2
  • 3
  • 4
  • 5
  • 6
  • 7
  • 8
  • 9
  • 10
  • 11
  • 12
Teaching time Study time Type of examination Credit points
ca. 30 hours ca. 30 hours Study paper and oral examination 6
Module leader
Prof. Dr. Barbara Sickmüller, Dr. Michael Horn

Module contents

Teil 1 - Formal aspects of maintaining the authorisation

  • Application for authorisation renewal
  • Extension of the marketing authorisation according to § 31 AMG
  • Extension of the registration according to § 39 AMG
  • Application form
  • Annexes to the application
  • Deadlines according to the Medicinal Products Act
  • Missing the deadline
  • Legal options if the deadline is missed
  • Harmonisation of renewal dates (GVD) national / EU
  • Official decision
  • Conditions
  • Reasons for refusal
  • Legal options in the event of refusal
  • Importance of the Federal Gazette
  • EU procedure: Renewal: MRP (CMS/RMS), Centralised procedures
  • Traditional medicinal products
  • Homeopathic medicinal productsl

Measures to maintain marketing authorisation

  • Notification of variations
  • Maintenance and updating of authorisation dossiers


Teil 2 - Pharmacovigilance (medicinal products for human use)

  • Pharmacovigilance system of a pharmaceutical company and pharmacovigilance master file - Pharmacovigilance System Master File (PSMF)
  • Responsible person for pharmacovigilance (QPPV) / step-by-step plan officer according to AMG
  • Pharmacovigilance Risk Assessment Committee (PRAC) of the EMA
  • Recording, reporting and assessment of adverse reactions after authorisation (national / EU)
  • Product-specific risk management and creation of a risk management plan - Risk Management Plan (RMP)
  • PPeriodic reports (PSUR / PBRER), PSUR Single Assessment (PSUSA)
  • EU - reference dates and EURD – list
  • Management of signals: detection, validation, confirmation, analysis, assessment and measures
  • PV referral procedures in the EU: legal basis, triggering, process, resulting measures with decisions and their implementation
  • National step-by-step plan procedure
  • Post-Authorisation Safety Studies (PASS) / Post-Authorisation Efficacy Studies (PAES)
  • Direct Healthcare Professional Communication (DHPC) and 'Red Hand Letter'
  • Educational Material and German regulations for officially authorised training material (‘Blue Hand’)
  • Drug therapy safety
  • PV inspections/ PV audits
  • Requirements for biological medicinal products

Study plan

Part 1
Friday 07.02.2025 von 08:30 - 18:30 Uhr Online
Pharmacovigilance
Saturday 08.02.2025 von 08:00 - 16:00 Uhr Online
Pharmacovigilance
Part 2
Friday 21.02.2025 von 08:30 - 18:30 Uhr Universitätsclub Bonn e.V.
Maintenance of Marketing Authorisations
Saturday 22.02.2025 von 08:00 - 16:00 Uhr Universitätsclub Bonn e.V.
Maintenance of Marketing Authorisations
Submission of study paper Monday, 24.03.2025  

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