Claudia Hey

Claudia has Extensive regulatory affairs expertise including early clinical development, registration, post-marketing and life-cycle management. Claudia also brings significant leadership skills in regulatory policy engagement and advocacy.
At Biotest (Dreieich, Germany) she have worked since 2008 in Corporate Regulatory Affairs. Biotest is a medium sized company specialized in innovative hematology and immunology products. Claudia had responsibility for several biologics in EU and U.S. and led numerous regulatory strategic Health Authority interactions including: Regulatory Strategies, Mutual Recognition Procedures, Variations, Conditional Approval, Clinical Trial Applications, Scientific Advice Meetings, Application for Orphan Drug Designation.
Prior to joining Biotest, she have worked for 4 years as Manager of Innovation / Regulatory Affairs / Production and Quality in the German Association of Research-Based Pharmaceutical Industry (vfa) in Berlin. She led several expert groups at vfa, such as the Regulatory Affairs committee, Manufacturing and Quality committee, Primary Packaging Materials committee, Active Pharmaceutical Ingredients committee, and Drug Safety committee. She was also instrumental in the implementation and adoption of key European pharmaceutical legislation and regulation via vfa (e.g. Pharmaceutical Legislation, Counterfeit Medicines, EU Research Programs, Medicines for Children, Scientific Advice, etc.).
She have started her career at Merck Consumer Health (Darmstadt, Germany) in 1997 in Scientific Services and Project Management. She joined the International R&D department in Merck Consumer Health Care in 1998. From 2000 to 2003 she have headed Project Management, Regulatory Affairs and Scientific Services at Merck Consumer Health Care. She hold a Doctorate in Pharmacy from the University of Frankfurt (Germany). Her research work focused on immunological control mechanisms in the airways.