Dr Ilisa Bernstein of FDA CDER Office of Compliance To Keynote PSM Interchange

Dr.Bernstein-picture-200x300The Partnership for Safe Medicines (PSM) announced recently that Ilisa Bernstein, Pharm.D, JD, Deputy Director of the U.S. FDA Office of Compliance in the Center for Drug Evaluation and Research (CDER), will be the keynote speaker at their annual Interchange event next Thursday, October 24, 2013 at the Newseum in Washington DC.  RxTrace is a media partner for the event again this year and I plan to attend.

According to the PSM website:

“The annual Interchange brings together policymakers, pharmaceutical manufacturers, patient advocates, law enforcement, healthcare professionals, and anti-counterfeiting companies to discuss the problem and solutions to the global scourge of pharmaceutical counterfeiting.”

Dr. Bernstein has spent the better part of her career at the FDA focusing on the challenges of protecting U.S. and global patients from counterfeit and otherwise illegitimate drugs in various roles at the FDA.  She has served as Deputy Director of the FDA CDER Office of Compliance for two years.  Prior to that, Dr. Bernstein was the Director of Pharmacy Affairs at the FDA.  She is no stranger to many of us who have been working on drug serialization and tack & trace over these same years.  She is highly regarded and I look forward to her presentation.

Other speakers, moderators and panelists at the PSM Interchange 2013 include:

  • Christopher Weaver, Medicine and Science Writer for the Wall Street Journal. Mr. Weaver has broken several stories concerning the discovery of counterfeit cancer medications in the U.S. supply chain.
  • Special Agent Daniel Burke, Senior Operations Manager in Charge of Cyber-Crime Investigations for the FDA’s Office of Criminal Investigations will talk about the risks to consumers from using fake online pharmacies.
  • Roger Gural of the U.S. Department of Justice Consumer Protection Branch will tell us about counterfeit cases he has resolved, and what consumers have been exposed to by the actions of drug counterfeiters.
  • Tim K. Mackey, PhD, Assistant Professor, University of California, School of Medicine, Department of Anesthesiology and President, Partnership for Safe Medicines
  • Marv Shepherd, PhD, Director, Center for Pharmacoeconomic Studies, College of Pharmacy, University of Texas
  • Scott Williams, Director, American Cancer Society Cancer Action Network
  • William E. Arnold, CEO and Vice-Chair, Community Access National Network
  • Suzanne Willard, President-Elect, Association of Nurses in AIDS Care
  • Dr. Bryan Liang, PhD, MD, JD, Professor of Anesthesiology and Director, San Diego Center for Patient Safety, University of California, San Diego School of Medicine and Medical Director, Program on Health Policy & Law, University of California, San Diego, as well as Vice President, Partnership for Safe Medicines
  • Amelia Arnold, Pharm.D., Clinical Pharmacist, Community Pharmacies, Maine
  • Gg Levine, Policy and Communications Project Manager, National Association of Boards of Pharmacy
  • Bejon Misra, Partnership for Safe Medicines India
  • Chuck Forsaith, Corporate Director, Supply Chain Security, Purdue Pharma Technologies, Inc.
  • Assistant US Attorney Sam Louis, Deputy Chief Program Fraud Division
  • Andy Shuttleworth, Unit Chief, National IPR Coordination Center
  • Linda Marks, Senior Litigation Counsel of the Consumer Protection Branch of the U.S. Department of Justice
  • Scott Ballman, Technical Expert for IP Program – North America, World Customs Organization
  • Dr. Patrick Lukulay, Vice President of Global Health Impact Programs at USP and Director of the USAID Promoting the Quality of Medicines Program
  • John Roth, Director U.S. Food and Drug Administration Office of Criminal Investigations
  • Scott LaGanga, VP, Public Affairs – Advocacy, Pharmaceutical Research and Manufacturers of America and Director, Partnership for Safe Medicines

You can register here.  I hope to see you there.

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