Janet König

Janet König

Company: BfArM

Job title: Head, Unit on Anesthesiology/ Algesiology/Rheumatology/ Pulmonology/ENT

Bio:

Janet Koenig is the Head of Unit Anaesthesiology, Algesiology, Rheumatology, Pulmonology, ENT in the Division Licensing at the German Federal Institute for Drugs and Medical Devices (BfArM). Mrs. Koenig is also the German alternate member of the CHMP. She received her M.D. at University of Goettingen Germany (1998) and her Board Certificate in Surgery at University Hospital of Bonn, Germany.

Seminars:

Panel Discussion: Developing Conversations Among Regulators & Industry Experts 9:30 am

• Exploring the regulators current expectations • Evaluating common challenges faced by all industry leaders with regards to regulatory guidelines • How will regulatory guidance change in response to AI and digitalisation of dermatology drug development? • Looking ahead: Predicting the future of dermatology drug developmentRead more

day: Day One

Keynote Session by BfArM: Equivalence Assessment of Topical Products: Justification of the Current Regulatory Approach by EMA 9:00 am

• Updating the CHMP/QWP draft guideline on quality and equivalence of topical products since December 2018 • Evaluating changes in formulation, dosage form, method of administration and manufacturing processes that significantly influence efficacy and safety • Assessing why clinical therapeutic equivalence studies are necessary, but also how other models can be used and developed •…Read more

day: Day One

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