Introduction to Regulatory Affairs as a Career

Centre biomed firstzeichenfla %c3%aache 3 s

Tuesday, 7th March 2023 | in-person workshop

The workshop will give a selective overview of some key concepts of the role of regulatory affairs within drug development and drug life cycle management (LCM). The workshop will start with an awareness of the regulated world in which we live. Then focussing primarily on pharmaceuticals (medicines), the course will look at the drug development process, the function and role of regulatory affairs within drug development and LCM and the “ecosystem” of players – ie companies, service companies and medicine agencies. Key regulatory processes and vocabulary will be highlighted and examples given. The workshop will include some short interactive exercises to supplement theory. There will be a discussion of how the drug development process is evolving (“Hot Topics”) and how this impacts / will impact the regulatory affairs role in the future. The aim of the workshop is to enlighten participants on the multifaceted role of regulatory affairs and how one can transition from laboratory research into this applied field within industry and importantly, provide some Q&A to “is a career in regulatory affairs a suitable option for me?”.

Dr. Ann McCormack did her PhD in pharmacology (University of Leeds, England), and has been working in regulatory affairs for several companies since 1999, before becoming an independent contractor for 1) an established dermatology company and 2) a USA start-up that is developing protein therapies.

Drug Discovery: From target validation to clinical development

Centre biomed firstzeichenfla %c3%aache 3 s

Tuesday, 9th May, 2023 | 4:00 pm | online-lecture by PD Dr. Aimo Kannt

Probably more than in any other industry, sustainable growth and profitability of pharma companies rely on their ability to innovate and discover new treatments for diseases with unmet medical needs. This lecture will give an overview of the drug discovery process from target idea to preclinical development. It will focus on risk management in drug discovery and will outline scientific as well as organizational and strategic challenges associated with the different stages of pharma R&D.

GRADE BioMed FIRST - past workshops & lectures

Here you will find an overview of events of the GRADE Center BioMed FIRST in 2023.


10./17./24. Jan. 


  Introduction to Data Science with Python for Beginners (online)
with Jan Zacharias and Tom Schwitzkowski

12./19./26. Jan.


  Introduction to Data Science with R and the Tidyverse (online)
With Karlo Lukic and Lara Zaremba (both TechAcademy e.V)