Bettina Doepner | Director, Therapeutic Area Lead EU Region Global Regulatory Affairs
CSL Behring

Bettina Doepner, Director, Therapeutic Area Lead EU Region Global Regulatory Affairs, CSL Behring

Dr Bettina Doepner is a Director Regulatory Affairs. She started her career in the pharmaceutical industry more than 20 years ago. In global as well as the European regional roles in headquarters of several pharmaceutical companies she gathered comprehensive professional experience in the areas of drug development, clinical research, and the management of regulatory procedures, as well as a strong knowledge base of relevant regulations and guidelines. Her experience includes the review of development plans and implementation of global pre- and post-approval regulatory strategies, and the negotiation thereof with Health Authorities. She is currently working at CSL Behring GmbH in Marburg/Germany as Regulatory Therapeutic Area Lead responsible for the Region EU/Switzerland.


Drug Safety World Day 1 @ 15:30

Understanding the key aspects of Benefit Risk Assessments from a regulatory perspective and how the patient is involved in the discussion

  • How benefit-risk assessments form the fundamental basis of regulatory decision making?
  • Benefit-Risk Assessment initiatives: How to move away from separate contributions of efficacy evidence and risk data to a consolidated meaningful database
  • The patient voice in Benefit-Risk Assessments: How do you include the patient in the benefit: risk assessment at an early stage in drug development?

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