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Complimentary: Regulatory and Real World Evidence Challenges of Rare Diseases and Orphan Drugs

Speakers

Patricia  Anderson MSc, RAC, FRAPS, RAC

Patricia Anderson MSc, RAC, FRAPS, RAC

Vice President, Regulatory Services, Redhill Biopharma Ltd., Canada

Ms. Anderson has covered many aspects of drug development during over 30 years in the pharmaceutical and biotechnology industry. Ms. Anderson has held several positions which have included the areas of regulatory affairs, drug development, and due diligence for licensing. She has arranged and been involved in meetings with many global agencies including the FDA, and the EMA, including a successful CHMP arbitration. In 2015 she was awarded the designation of Fellow by RAPS.

Mike  Cloutier

Mike Cloutier

President and General Manager, InterMune Canada, Inc., Canada

Karl  Gregor, PharmD, MS

Karl Gregor, PharmD, MS

Vice President, Product Value Strategy Consulting, Optum, United States

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