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Virtual Event

2021 年 06 月 22 日 9:30 上午 - 2021 年 06 月 22 日 12:30 下午

Horsham, PA 19044

#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

Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor at the Faculty of Health Sciences, University of Copenhagen. From 2004-9 ST worked at the Danish Medicines Agency acting as member of CHMP and additionally CAT at the European Medicines Agency. Following a short period involved in developing best practice guidelines for primary care ST rejoined the DKMA as Head of the Licensing. From 2013-22, Prof Thirstrup worked asdirector and strategic consultant for NDA Group AB. From June 2022 Prof Thistrup is the Chief Medical Officer of the European Medicines Agency.

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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