Standardizing REMS What’s The Status?

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75% of drug industry stakeholders see the FDA’s intent to reform individualized REMS programs as a good thing.

But things appear a bit stalled.  Despite this delay, you can still move ahead with your own preparation for standardized REMS. Here’s how …

What can you do now to assure you’re ready to comply — and benefit from — the standardization of REMS?  Plenty.

That’s because various industry groups and associations are hard at work hammering out real-world REMS reference guides that map out what you can do today to improve your programs and anticipate what the FDA guidance is likely to include.

These include:

  • Industry Work Group (IWG): The IWG is a consortium of pharma companies — primarily opioid sponsors — working with FDA to provide feedback and input on a classwide REMS.
  • Physicians Insurers Association of America (PIAA): This trade group represents medical liability carriers and is increasingly involved in shaping REMS CME programs.
  • iHealth Alliance (iHA): This nonprofit, which includes representation from medical societies, liability carriers, sponsors, trade groups and the FDA, provides REMS- and AER-related tools to safeguard patient safety and protect provider interests and liability as healthcare moves to an electronic realm.

In just 90 minutes on Tuesday, July 19, the FDA webinar Standardizing REMS: What’s The Status? will bring you up to date on REMS standardization and the invaluable guides and templates that are available to you now.

Plus, you’ll get hands-on guidance from our knowledgeable webinar leader, Dr. Edward Fotsch, who will also cover the realities for industry related to REMS, what to expect in the future of REMS and will share new electronic strategies for engaging providers.

Plan now to attend this webinar, and you will learn:

  • How standardization affects various types of REMS
  • The process and challenges of integrating elements to assure safe use (ETASU) into your REMS
  • Updates on the FDA/IWG and the new approach to the patient-provider agreements (PPA)
  • Best practices for managing the unique aspects of REMS for long-acting opioids (LAOs)
  • Pitfalls to avoid as the REMS and CME landscape changes
  • New electronic strategies for engaging providers
  • And more

A flexible fit for your busy schedule

The Standardizing REMS webinar is convenient to attend. All that’s required is that you be in front of a screen at the appointed time, whether you’re at the office or telecommuting from your office-in-home.

Of course, Dr. Fotsch will be on hand to answer all of your questions. Simply submit your questions via email, and you’ll have answers by the time the session ends.

Everyone in your organization — from CEO, Chief Medical Officer and regulatory executives, to product managers, medical affairs executives and Chief Patient Safety Officer — will benefit from taking part in this event. Best of all, everyone can do so at a cost that won’t break the budget. You pay one single low registration fee per facility, regardless of how many participate. So spread the word.

  • CEOs and other strategic senior executives
  • Regulatory executives who are involved in the design, FDA approval or implementation of REMS
  • Senior product and marketing executives
  • Chief Medical Officers
  • Medical affairs executives
  • Chief Patient Safety Officers

Edward Fotsch, M.D., is CEO of PDR Network LLC, which includes the Physicians’ Desk Reference (PDR), the most widely used physician/prescriber resource for drug information; and the Health Care Notification Network (HCNN), which is the only FDA-compliant system that provides U.S. physicians with electronic delivery of FDA-mandated, medical specialty-specific product safety alerts. Dr. Fotsch is a member of several national health information technology (HIT) committees and panels including the HHS, HL7 PHR and JCAHO HIT Committees, the CMS PHR Evaluation Task Force, and the Markle/Connecting for Health Personal Health Technology Committee.

Register now!

Date: July 25 – Aug. 12, 2011
Location: Your office or conference room (no need to travel!)
Time: Anytime

Gather your team for maximum benefit! Your investment is for one dial-in.

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