Regulatory Affairs
23 September / 1 October 2026 | 16:30-18:00 | online
Day 1 – Introduction: Fundamentals of Drug Regulatory Affairs
Pharmaceutical companies are not allowed to place drugs (medicinal products) on the market without a valid marketing authorisation. Rather, they must apply for a marketing authorisation and submit a dossier with structured and comprehensive information regarding quality, safety and efficacy aspects. The competent authorities conduct a benefit-risk assessment which forms the basis for their final decisions.
But why is this required and how can marketing authorisations be obtained? The introduction to fundamentals of Drug Regulatory Affairs will provide explanations to those questions, with a focus on Europe.
The following topics will be addressed in the webinar:
- What is the definition of a drug?
- Why are marketing authorisation applications required?
- How can marketing authorisations be obtained in Europe?
- How does practical work in Drug Regulatory Affairs look like?
- Outlook
Day 2 –Workshop Intro to Drug Regulation: Understanding Quality, Safety, and Efficacy
A short, hands-on workshop that shows how authorities decide whether a new medicine can be sold. Work in small groups on a fictional Paracetamol product and gather simple, easy-to-follow information on how it is made, its safety, and its effectiveness. By the end, you’ll have three clear, bite-sized summaries that illustrate how a regulatory submission is put together—without jargon.
What you’ll learn
- The basic idea behind drug approval and why data matters
- Three clear areas: manufacturing/quality, safety, and efficacy
- How to write concise, evidence-based notes that show a product is safe and effective
Trainers:
- Dr. Michael Felkel, Dermapharm AG, Grünwald
- Dr. Felix Kern, Merck KGaA, Darmstadt
International School of Pharmacology Giampaolo Velo: Common mechanisms in cardiovascular disease and cancer: focus on platelet activation and inhibition
The aim of the course is to focus on recent scientific knowledge concerning common pathophysiological, clinical, and therapeutic aspects of cancer and cardiovascular disease. Particular attention is given to mechanisms of platelet activation and the interactions between platelets and pathways of inflammatory and immune response, as well as to drugs that target platelets in both clinical and experimental treatments across diverse clinical contexts. Senior Scientists will mentor early-career researchers in these advanced topics by showcasing their recent research findings. Consistent with the International School's tradition, participants are encouraged to actively engage in discussions and to present their scientific work through posters or brief oral presentations.
For more details see: https://isphav.org/events/common-mechanisms-in-cardiovascular-disease-and-cancer-focus-on-platelet-activation-and-inhibition
The GRADE Center BioMed FIRST can support participation for up to 5 ECRs by covering the registration fee. Please contact Brigitte Held, held@grade.uni-frankfurt.de
Date and venue: October 26 – 28, 2026 | Erice, Sicily
Course direction: Pietro Minuz, Paola Patrignani, Carlo Patrono
Organizing Committee: Bernhard Brüne, Andrea Dalbeni, Cristiano Fava, Michael Holinstat, Ruth Langley, Rahul Roychoudhuri, David Sacerdoti, Dieter Steinhilber, Stefania Tacconelli
BioMed FIRST Winter School 2027
March 15-19, 2027 | Obergurgl, Austria
Planned topics:
- Lipid mediators in cancer and inflammation
- Recent development in extracellular vesicle research
- Vitamin D and its role in health and disease
- RNA-based aptamers, development and applications
- antiviral strategies
For participation, please contact Brigitte Held, held@grade.uni-frankfurt.de
