The 17th Annual FDA-OCRA Educational Conference: Integrated Regulatory Pathways in a Global Market on June 4, 2014

 

FDA Centers

FDA Los Angeles District Office and

Orange County Regulatory Affairs Discussion Group

Present

The 17th Annual FDA-OCRA Educational Conference

Integrated Regulatory Pathways in a Global Market

June 4-5, 2014

Join us For This year’s FDA-OCRA Educational Conference
Featuring a New Clinical Trial Track in 2014!
8:00 – 9:45 am     Considerations for Performing Global Clinical Trials
Moderator:  Ginger Clasby, VP, Clinical & RA/QA, Transcend Medical,  Inc.
Speakers:     Laurie Taddonio (Former FDA BIMO Investigator), President, LMT Consulting
Allison Oliva, RAC, Principal, Comprehensive Clinical Consulting
Bruce Van Deman, Sr Director, Global Clinical Affairs, Edwards Lifesciences, Heart Valve Therapy
9:45 – 10:00 am    Break
10:00 – 11:45 am   Latest Trends in Global Clinical Trials and Development
Moderator:      Lei Zhang, PhD, Associate Director, Clinical Development, Cytori Therapeutics
Speakers:     Norman Viner, MD, Chief, Clinical Trials Division, Centre for Evaluation of          Radiopharmaceuticals and Biotherapies (CERB), Biologics and Genetic  Therapies Directorate (BGTD), Health Canada
Razelle Kurzrock, MD, Murray Professor of Medicine, Sr. Deputy Center  Director for Clinical Science, Director Center for Personalized Therapy  & Clinical Trials Office, Vice Chief Division of Hematology & Oncology,   UC San Diego Moores Cancer Center
Sherri Hubby, (Former FDA Consumer Safety Officer) Director QA, US, Premier Research Group
11:45 am – 1:00 pm    Lunch
1:00 – 2:45 pm   Precision Medicine: A Medical Miracle or An Ethical Nightmare?
Moderator: Linda G. Strause, PhD, Principal, Strategic Research Consulting
Speakers:     Glen Freiberg, RAC, (Former FDA Investigator) Consultant, RCQ Consulting
Michele Yelmene, Head of Biotech Division, Pharmalink Consulting
Hillary Theakston, Executive Director, The Clearity Foundation
2:45 – 3:00 pm    Break
3:00 – 4:45 pm   Risk Management: Postmarketing Requirements & Strategies
Moderator: Peggy Pence, PhD, RAC, FRAPS, President/CEO, Symbion Research International
Speakers:    Michael J. Klepper, MD, President/Co-Founder, Drug Safety Navigator LLC
Morris Sherwood, Director, Regulatory Affairs/Quality Assurance, Isolite Systems, Inc.
Robert R. Reynolds, ScD, VP & Global Head, Epidemiology, Worldwide Safety Strategy, Pfizer       Adjunct Associate Professor, Department of Epidemiology, Tulane University
Register Today at https://ocra-dg.org