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
| 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
Prof. Dr. Barbara Sickmüller, Dr. Michael Horn
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
| 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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