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FDAnews announces Fifth Annual Risk Management & Drug Safety Summit

FALLS CHURCH, Va., Nov. 9, 2012 /PRNewswire-iReach/ --
Fifth Annual Risk Management & Drug Safety Summit:
Building an Effective Global Risk Management and Drug Safety Program
**Presented by FDAnews**
Dec. 3-4, 2012 – Washington, DC


There are now about 200 unique REMS and four classwide REMS.  And big changes are coming.

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 preapproval and postapproval. 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'll 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 Requirement — 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 Fifth Annual Risk Management and 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."

Meet Your Chair:

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.

Host Sponsor:
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

Who Should Attend

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


Fifth Annual Risk Management & Drug Safety Summit:
Building an Effective Global Risk Management and Drug Safety Program
**Presented by FDAnews**
Dec. 3-4, 2012 – Washington, DC

TUITION: $1,967 per attendee

4 Easy Ways to Register
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

Media Contact:
Jeff Grizzel FDAnews, 703-538-7668,

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