REMS 2014

REMS 2014 - Webinar CD/Transcript

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REMS 2014: Prepare for New Clarifying Guidances and Assessment Requirements

The FDA’s complex REMS requirements are likely to change in 2014.

Are you ready for what’s coming?

Many industry watchers predict the agency will issue a new, clarifying REMS guidance in 2014.

Some of the changes might include:

  • Standardizing REMS between brand and generic drugmakers
  • Efforts to maintain some level of flexibility within shared REMS so individual companies can implement them
  • Which formats and training approaches are most effective for prescriber training and how frequently prescribers should be asked to take REMS training
  • Issues pertaining to dispenser certification and distribution of REMS drugs
  • Addressing critics’ concerns that the FDA relies on a small amount of data regarding its decisions to require a risk mitigation plan or to discontinue one already in use

So, do you still think you’re ready for what’s coming?

Would you like to be guided through the new REMS opportunities and risks awaiting you?

Order the webinar CD and transcript for a hands-on learning experience by a trusted REMS expert. Understanding and leveraging REMS is critical for anyone who oversees compliance in a number of areas, including: postmarket surveillance, labeling, clinical trial development, product liability and many more.

What if you could discover the tips and tricks that will help you make your REMS effective today and ready for possible changes 2014?

Well, you can.

REMS compliance expert Howard Dorfman conducts a tested approach to bulletproofing your REMS compliance strategy.

The FDA expects you to be able to defensibly determine whether your product demands a REMS. But your team needs to understand the ins and outs of the requirements if they are to make an intelligent decision. Mr. Dorfman will help your team better understand:

  • Negotiating with the FDA to establish appropriate measurements in assessing the “success” of any REMS
  • Establishing intra-company policies and procedures to maximize early identification of REMS progress
  • Documenting FDA actions and decisions to help establish both an effective risk minimization program – and the basis for any product liability defense if things go sour

Step by step, Mr. Dorfman walks you through the FDA’s expectations and when and how you need to meet them.

A well-written and implemented REMS can safeguard against FDA enforcement actions and serve as a protection plan against high-stakes lawsuits.

  • Regulatory affairs professionals
  • Medical affairs and pharmacovigilance executives
  • Product lifecycle managers
  • Labeling specialists
  • Risk management specialists
  • General/corporate counsel
  • Compliance officers
  • Executive management
  • Outside attorneys

Howard Dorfman is Vice President and General Counsel at Ferring Pharmaceuticals Inc., the U.S.-based subsidiary of Ferring Holding, a pharmaceutical, medical device and biotech company where he is responsible for all legal matters relating to the company’s U.S. operations. Mr. Dorfman has lectured and published widely on a wide range of pharmaceutical product liability and food and drug law regulatory issues. His articles have appeared in the Food and Drug Law Journal, the Rutgers Law Review, and the Seton Hall Law Review. He is currently an adjunct professor at Seton Hall Law School where he teaches a course on Pharmaceutical and Medical Device Promotion, Advertising and Communication.