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Virtual

Jun 22, 2021 9:30 AM - Jun 22, 2021 12:30 PM

#025A: Optimizing Your Interaction With EU Regulatory Authorities: How to Prepare and Perform

Instructors

Steffen  Thirstrup, MD, PhD

Steffen Thirstrup, MD, PhD

Chief Medical Officer, European Medicines Agency, Netherlands

Dr. Steffen Thirstrup, MD, PhD, has been Chief Medical Officer at the European Medicines Agency (EMA) since June 2022. A specialist in clinical pharmacology, he has held leadership roles at the Danish Medicines Agency, served as a CHMP member at EMA, and co-chaired the European Commission’s biosimilar market access group. An adjunct professor at the University of Copenhagen, Dr. Thirstrup has authored over 40 publications and co-edited a key Danish pharmacology textbook. He divides his time between Amsterdam and Værløse, Denmark.

John  Ellis, MBA

John Ellis, MBA

Communications Coach, PharmApprove, United States

John Ellis has been communications coach at PharmApprove since 2008. He has coached upwards of thirty teams as they have prepared for FDA advisory committee meetings, as well as OE's and SAG's in Europe. In addition, he creates and delivers workshops on a range of communications skills, from presenting to Q&A to meeting mastery. He also coaches one-on-one with senior leaders in pharma. John has an MBA from Yale. He studied English literature and art history at Williams College. He began his career as an actor in Los Angeles and New York.

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