The FDA Under a New Commissioner - Webinar CD/Transcript

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The FDA Under a New Commissioner

New leadership is coming to the FDA, and every FDA-regulated executive wants to know how it will affect them.

Likely new FDA Commissioner Scott Gottlieb is an old agency hand thrust into a new role. Will he toe the Trump line ... or show independence? Is his past a guide ... or will he strike out in new directions? Will he ease new drug and device approvals ... or toughen them? Increase inspections ... or ease off? More 483s and warning letters ... or fewer?

Whether you’re in drugs, biologics, devices or clinical trials, you need answers now.

Join us for a deep dive into the future of drug and device regulation, featuring two speakers who know the FDA inside and out:

  • Wayne Pines was the FDA’s chief media spokesman for seven years. He has authored or edited a dozen books about crisis communication and the FDA, and was named the FDA Alumnus of the Year in 2004. He is a director and former president of the Alliance for a Stronger FDA, a coalition of 200 organizations seeking more appropriated funding for FDA. Books include the FDA Advertising and Promotion Manual; A Framework for Pharmaceutical Risk Management; How to Work With the FDA; Making Your Case to the FDA: Strategic Communication Before, During and After Your Drug’s Approval; A Practical Guide to Food and Drug Law and Regulation; and Communicating in a Health Care Crisis. He now manages crisis communications for FDA-regulated clients as a senior consultant with Apco Worldwide.
  • Peter Pitts worked directly with Scott Gottlieb while at the FDA. Mr. Pitts was senior communications and policy adviser to the FDA Commissioner, and associate commissioner for external relations supervising the offices of public affairs, special health issues, executive secretariat and ombudsman and the advisory committee on oversight and management. He co-founded and is now president of the Center for Medicine in the Public Interest.

In 90 fast-paced minutes, speakers will address core questions including:

  • What is likely to change at FDA under President Trump and Commissioner Gottlieb that will affect what you do every day
  • Expert, inside insights on how your company or organization should plan for change NOW to achieve your goals for 2017 and beyond
  • The announced and unannounced priorities that the new administration will establish under Mr. Gottlieb’s direction
  • Specific, practical guidance for companies seeking to prepare for change and to determine how Mr. Gottlieb’s background and administrative and regulatory leanings will play out as Commissioner, including his stance toward patients and regulated industry
  • And much more!

This urgent Web-based event is a must for every regulatory affairs and product development executive in your organization. Start building a list now of staffers who ought to be on hand ...

Your Presenters

Wayne Pines, President, Health Care, APCO Worldwide

Peter Pitts, Co-founder and President, Center for Medicine in the Public Interest