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FDAnews Announces Fifth Annual Risk Management & Drug Safety Summit

Building an Effective Global Risk Management & Drug Safety Program / Dec 03-04 2012 -- Washington DC -- Presented by FDAnews /

(PresseBox) (Falls Church, VA, USA, ) FDAnews has announced details of its upcoming meeting, the 5th Annual Risk Management & Drug Safety Summit: Building an Effective Global Risk Management & Drug Safety Program, to be held Dec 03-04 2012 in Washington DC.

All regulatory affairs, R&D, executive management, risk management and medical safety managers, and any personnel tasked in this area are encouraged to attend. For details visit the summit site: []


There are now about 200 unique REMS and four classwide REMS.

PDUFA V moves REMS discussions earlier in the review process for sponsors of new molecular entity NDAs and original BLAs. With REMS discussions commencing as early as pre-NDA meetings, the agency is determining how to create a more predictable system for requiring REMS and deciding what tools a REMS should involve.

CDER (in conjunction with CBER) plans to issue new guidance to determine when a REMS is required, both pre-approval and post-approval. The guidance must be released in September 2013.

Plus, the FDA is planning to hold a series of public meetings to determine the best methods for assessing the effectiveness of REMS.

Are you in the know on these changes? Will you be ready when they hit your product?

Register Today to join a select group of drug industry executives who have, over the past four years, sought to shape the future of REMS and global drug safety.

This is your year to be among them. Register now to join with colleagues for the Fifth Annual Risk Management and Drug Safety Summit.

Invest two days. Meet new colleagues and make new contacts. Ask questions directly of industry thoughts leaders, such as Douglas Throckmorton, M.D., Deputy Director Regulatory Programs, CDER, FDA (invited), Greg Fiore, M.D., Chief Medical Officer and Acting Head of Global Pharmacovigilance, The Medicines Company and Richard Hermann, M.D., M.P.H., Safety Science Physician, AstraZeneca.

Click here to see the agenda

You will also be brought up to speed on these critical topics:

CDER's Efforts to Improve Risk Management and Drug Safety
Problems Encountered When Innovator and Generic Firms Have to Share a REMS
How to Design an Effective ETASU with Integrated Digital Elements
Suspicious Order Monitoring (SOM) Regulatory and Policy Requirements -- An Effective Investigative Program
Application of the Benefit-Risk Action Team (BRAT) Framework in Pharmaceutical R&D
Panel Discussion: Opioid REMS and What It Signals for the Future of REMS
The Powerful New Platform for Risk Management and Safety Communications: Electronic Health Records
Pharmacoepidemiology in Safety Signal Assessment

How will the 5th Annual Risk Management & Drug Safety Summit make a bottom-line difference to you? Here's what previous attendee Parul Vold, Medical Director, Global Pharmacovigilance, Lundbeck, Inc., said:

"This is the best conference on risk management that I have ever attended. It is money well spent. Even seasoned pharmacovigilance persons will learn something new and/or gain a valuable new perspective."


Peter Pitts is co-founder and president of Center for Medicine in the Public Interest. Prior to founding CMPI, Mr. Pitts was a senior fellow for healthcare studies at the Pacific Research Institute, a San Francisco-based think tank. From 2002-2004, he was the FDA's associate commissioner for external relations, serving as the agency's "chief messaging officer," where his challenge was to clearly define the FDA's brand image and to communicate the agency's main themes to its many constituencies.


Center for Medicine in the Public Interest is a nonprofit, nonpartisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, healthcare reform and comparative effectiveness.

Register Today


Executive Management
Regulatory Affairs
Risk Management Professionals
Clinical Safety/Pharmcovigilance
Medical Affairs/Medical Safety
Commercial Affairs/Business Development
Clinical Trial Directors


5th Annual Risk Management & Drug Safety Summit:
Building an Effective Global Risk Management & Drug Safety ProgramPresented by FDAnews
Mon & Tue, Dec 03-04 2012 -- Washington DC USA

TUITION: $1,967 per attendee


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


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.


Written cancellations received at least 21 calendar days prior to the start date of the event will receive a refund -- less a $200 administration fee. No cancellations will be accepted -- nor refunds issued -- within 21 calendar days from the start date of the event. A credit for the amount paid may be transferred to any future FDAnews event. Substitutions may be made at any time. No-shows will be charged the full amount. In the event that FDAnews cancels the event, FDAnews is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.


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.


FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.