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Hilton Washington DC/Rockville Hotel & Executive Meeting Ctr.

2017 年 04 月 23 日 8:00 上午 - 2017 年 04 月 23 日 5:00 下午

1750 Rockville Pike, , Rockville, MD 20852 , USA

Course: Regulatory CMC Training - The Basics to Prepare for the CMC Workshop

Instructors

Lin-Jau (Christine) Wu Anderson, BSN, MSc, RAC

Lin-Jau (Christine) Wu Anderson, BSN, MSc, RAC

Senior Research Scientist, Global Regulatory, Chemistry, Manufacturing & Control, Eli Lilly and Company, US, United States

Christine Anderson is a Senior Research Scientist, Global Regulatory Affairs CMC at Eli Lilly and Company, where she is responsible for global regulatory submissions to support clinical trials and market registrations for new products. She has, in the past 20 years, supported the CMC development for more than 50 new chemical entities including small molecule compounds and drug/device combination products. Additionally, in her earlier assignments with Lilly she became an experienced corporate auditor conducting GMP inspections worldwide. Prior to joining Lilly, Christine held quality control management positions with Key Pharmaceuticals and Baxter Diagnostics, Inc. in Miami, FL, US.

Elaine  Morefield, PhD, RPh

Elaine Morefield, PhD, RPh

Vice President, Regulatory Affairs, VaxForm, LLC., United States

Dr. Elaine Morefield is the Vice President, Regulatory Affairs for Vaxform,LLC. where she provides regulatory and development consulting services to clients. She also is working for Aclaris Therapeutics Inc., as the director of Product Quality, She obtained her BS pharmacy and her PhD in industrial and physical pharmacy from Purdue University. Dr. Morefield worked in the Office of New Drug Quality Assessment at the US FDA where she was the deputy office director for review and administration. Dr. Morefield has over 30 years of product development experience with pharmaceutical companies Wyeth, Schering-Plough and DSM and has developed over 100 pharmaceutical products.

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