Pharmaceutical products are heavily regulated to ensure quality, safety, and efficacy, particularly in the EU. This module focuses on medicinal products and the EU legal framework, with occasional consideration of other product groups and markets. The Regulatory Affairs section explores how regulations impact product development timelines, market-entry, and maintenance challenges using interactive case-based learning. It prepares students to communicate effectively with stakeholders such as Drug Development, Pharmacology, and Toxicology teams, as well as regulators. The Pharmacovigilance section introduces PV management, covering how to build and manage a compliant pharmacovigilance organization, including budgeting and the use of smart PV tools. The module also addresses challenges like pharmacovigilance audits and regulatory inspections faced by different types of pharmaceutical companies.
- Understand the basics and practical insights of regulatory affairs and pharmacovigilance
- Understand the key differences in drug regulation across major markets (EU and US)
- Understand the challenges of designing efficient regulatory strategies
- Understand the major PV tasks and organization of the Pharmacovigilance departments
- Understand budgeting and resource planning
- Understand the pros and cons of working with strategic partners
This course is part of the prestigious part-time Pharma MBA program, conducted in English on Fridays and Saturdays on Campus Westend. It offers a valuable opportunity to network and gain expertise without committing to a full degree program. As the number of seats is limited, we recommend to register early. If you're a GBS or Goethe University alumni, explore our attractive alumni discount options.
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Participants have the choice of completing the course with a qualified certificate or attending as a guest auditor. As an auditor, you are not required to complete assignments, take exams or earn academic credits.
| ECTS | Certificate | |
|---|---|---|
| Guest auditor | - | Certificate of Participation |
| Full participant | 5 CP | Qualified Certificate |
| Date | Session |
|---|---|
| Dates coming soon |