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FDA Compliance

Fourth Annual Risk Management and Drug Safety Summit

Nov. 1–2, 2011, in Washington D.C.

Published: Tuesday, October 18, 2011 - 10:24

(FDAnews: Falls Church, VA) -- FDAnews has announced details of its upcoming 4th Annual Risk Management and Drug Safety Summit: Building an Effective Global Risk Management and Drug Safety Program, scheduled for Nov. 1–2, 2011, in Washington D.C.

All professionals in regulatory affairs, risk management, clinical safety/pharmacovigilance, medical affairs/medical safety, research and development (R&D), commercial affairs/business development, and clinical trial directors are encouraged to attend.

With the Food and Drug Administration Amendments Act (FDAAA) of 2007 barely in the rear view mirror and the Prescription Drug User Fee Act V reauthorization rapidly approaching, drug safety, risk evaluation and mitigation strategy (REMS), and pharmacovigilance in the United States are about to undergo significant changes.

Meanwhile, the United Kingdom is forging ahead with its most significant pharmacovigilance legislation since 1995, with serious implications for applicants and holders of European Union marketing authorizations.

What will these changes mean for the pharma industry worldwide? Find out from an international roster of regulators and industry experts in Washington D.C. on Nov. 1–2, 2011.

Click here to see the full agenda.

Keynote speakers:
• Peter Pitts, co-founder, president, Center for Medicine in the Public Interest (chair)
• Edward Fotsch, M.D., CEO, PDR Network LLC (chair)
• John Lechleiter, Ph.D., CEO, Eli Lilly & Co.
• Janet Woodcock, M.D., director, Center for Drug Evaluation and Research (CDER), FDA
• Sir Alasdair Breckenridge, chairman, Medicines & Healthcare Products Regulatory Agency, UK
• Ravi Deshpande, vice president, McKesson Specialty
• John Jenkins, M.D., director, Office of New Drugs, CDER, FDA (invited)
• Ankur Makadia, PharmD, risk management plan leader, Global Clinical Safety & Pharmacovigilance, UCB
• Jane Axelrad, associate director for policy, CDER, FDA (invited)
• Deborah Autor, deputy commissioner, Globalization & Regulatory Operations, OC, FDA
• Josephine Torrente, director, Hyman, Phelps & McNamara (invited)
• Vaishali Patadia, Ph.D., director, head, Pharmacoepidemiology, Astellas Pharma (invited)
• Timothy Franson, M.D., senior vice president, health and life sciences sector, B&D Consulting; president, U.S. Pharmacopeial Board of Trustee; former vice president, global regulatory affairs, Eli Lilly & Co. research laboratories
• Meredith Manning, partner, Hogan & Hartson

Four easy ways to register:
Online: www.fdanews.com
By phone: (888) 838–5578 or (703) 538–7600
Fax: (703) 538–7676
Mail to: FDAnews, 300 N Washington St. Ste 200, Falls Church, VA, USA 22046–3431

Tuition is $2,297 per attendee.
Significant tuition discounts are available for teams of three or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount. Call (703) 538–7600 for details.

Program guarantee
You must be entirely satisfied with this learning opportunity, or FDAnews will refund your entire tuition, or extend a credit to a future FDAnews conference.


About The Author

FDAnews’s picture


FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the U.S. Food and Drug Administration (FDA). Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books, special reports, and conferences to stay in compliance with international standards and FDA’s complex and ever-changing regulations to get their products to market faster and boost profits.