In your studies 'Drug Regulator Affairs'
Studienmodule
MDRA-25 (WS 2023/2024 und SS 2024)
Modul 4 Generelle Aspekte des Modul 1 (CTD) und Zulassung besonderer Arzneimittelgruppen
Formale Anforderungen bei der Zulassung und Inhalte des Modul 1 CTD, Produktinformationstexte (Fachinfo, Packungsbeilage), spezielle Anforderungen zu Arzneimitteln der besonderen Therapierichtungen, Tierarzneimitteln, Blutprodukten, Impfstoffen und Arzneimitteln neuartiger Therapierichtungen (ATMP)
| Teaching time | Study time | Type of examination | Credit points |
|---|---|---|---|
| ca. 30 hours | ca. 30 hours | Study paper | 5 |
MA-Applications
with emphasis on administrative processes and content of the dossier in module 1
- E-submission basics: terminology & background
- Generic and informed consent applications
- Well established use
- Content of the dossier (modules 1, 2 and specific aspects for modules 3 and 4)
- Line extensions
- The marketing authorization application form
Product Information Management
- Clinical Trial reports according to Annex one of Directive 2001/83, Clinical Summary and Overview, relevant aspects in the assessment of clinical part of the dossier
- Assessment process, e.g. efficacy (Wirksamkeitsprüfung)
- Company Core Data Sheet
- Summary of Product Characteristics (SmPC)
- Package leaflet and consultation with target patient groups
- Labelling (Kennzeichnung)
- Labelling principles in national phases of EU procedures
Advanced Therapies
- Relevant Directives, Regulations, Guidelines
- Definition and classification: advanced therapy medicinal products, tissue products, combined products
- Authorization procedures
- Incentives
Biological anti-infectives: Vaccines (active and passive immunization)
- Definitions and particularities
- Legal basis for marketing authorisation (authorization procedures) and exemption from the obligation to obtain the marketing authorisation
- Access to investigational drugs during a public health emergency
- Specific aspects in the drug development, especially non-clinical and clinical development
- Influenza vaccines
- Live vectored vaccines
Blood products
- Specific regulatory aspects for Blood components
- Specific requirements for marketing authorization of blood products (example coagulation factors)
- Plasma Master File
- Official Batch Release
Specific aspects in marketing applications procedures for herbal and homeopathic medicinal products
(Arzneimittel der besonderen Therapierichtungen)
- Definitions
- Requirements (AMG, RL 2001/83/EC, pharmacopoeas)
- Possible MAA/registration procedures and required data on S, Q, E
- Herbal medicinal products: HMPWP, Botanical nomenclature, Extracts (labeling)
- Homeopathic medicinal products: the homeopathic principle, manufacturing rules, MAA and registration procedure
- Anthroposophical products (brief introduction)
Veterinary products
- Specifics for Veterinary Regulatory Affairs and Definitions
- Competent Authorities and Veterinary Legislation
- SmPC: VMP versus HMP
- Dossier Structure and Content
- Pharmacovigilance
| Part 1 | ||
|---|---|---|
| Friday | 12.01.2024 von 08:30 - 18:30 Uhr | Online |
| Saturday | 13.01.2024 von 08:00 - 16:00 Uhr | Online |
| Part 2 | ||
|---|---|---|
| Friday | 19.01.2024 von 08:30 - 18:30 Uhr | Paul-Ehrlich-Institut |
| Saturday | 20.01.2024 von 08:00 - 16:00 Uhr | Paul-Ehrlich-Institut |
| Submission of study paper | Monday, 15.04.2024 | |