Third Annual Risk Management and Drug Safety Summit

One Registration - Washington, DC
Oct. 18-19, 2010 - Early Bird Fee


When the next classwide REMS is announced, which drug class — and what companies — will it affect? Will you be among them?

Yes, the bad news is that you could be next … The good news is that there’s a way you could be much better prepared for a REMS.

How? By joining a select group of drug industry executives who have, over the last two years, sought to shape the future of REMS and global drug safety.

Register now to join with colleagues and officials from the FDA and the UK’s MHRA for the Third Annual Risk Management and Drug Safety Summit:

Invest two days. Meet new colleagues and make new contacts. Ask questions directly to speakers like CDER Director Janet Woodcock and MHRA Chairman Sir Alasdair Breckenridge. Listen to industry experts at two powerhouse panel discussions:

REMS “Veterans” Share Their Battlefront Tales. Negotiating a REMS with the FDA is tough.
A panel of veterans who have been through the REMS approval process show you how to leverage
the right medical, regulatory, legal, compliance and commercial expertise to succeed.

Reading the Drug Safety Tea Leaves: Top Legal and Compliance Challenges That Lie
This panel of top legal and regulatory experts discusses and analyzes what the future
might hold for REMS plans and drug safety initiatives — including which product classes might
be next in line for REMS.

Register Today!

You’ll also be brought up to date on these critical topics:

  • Status report on FDAAA and how its implications are still being felt throughout the drug industry;
  • How the FDA’s Sentinel Initiative will improve postmarket surveillance and safety;
  • Examination of recent REMS and what industry can learn from them;
  • Understanding the tips, tricks and secrets to REMS approval success;
  • Will PDUFA grant the FDA greater authority for REMS;
  • Implications from the FDA’s classwide opioid REMS
  • Best practices for presenting findings in REMS assessment reports; and
  • Balancing regulators’ “population” risk/benefit view with the doctors and patients’ “individual” risk/benefit view.

How will the Third Annual Risk Management and Drug Safety Summit make a bottom-line difference to you?  Here’s what previous-year 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.”

Host Sponsors

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, health care reform and comparative effectiveness.

United BioSource Corporation is a global pharmaceutical services organization that combines deep scientific knowledge with broad execution expertise across the lifecycle continuum. UBC’s focus is on generating real-world data to support the development and commercialization of medical products for emerging and established life science companies. UBC specializes in providing new and innovative ways to study drugs and devices.