ComplianceOnline

Commissioner Scott Gottlieb's Evolving FDA: Learn FDA's View, Mission and Its Impact on Your Company

Duration: 60 Min
Panelist
Peggy Berry
Peggy J. Berry MBA, RAC,President & CEO,Synergy Consulting (Ex-FDA Official)

Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014). She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book "Choosing the Right Regulatory Career" (RAPS, MD) and author of the 2011 book "Communication & Negotiation" (RAPS, MD).

Description:

This webinar will cover a variety of FDA issues that are important to developers of new and generic drugs, biologics and biosimilars, devices and apps as well as regulated communications and how the FDA, under Dr. Gottlieb's leadership is becoming both more predictable in its actions via more directive guidances as well as more collaborative (acting as both regulator of and partner with regulated industries).

You will learn how the FDA's view of its mission is evolving and how it will impact policies for development, review, post-market surveillance and communications.

Areas Covered:

This webinar will cover:

  1. Off label communications
  2. Patient-focused drug development
  3. Real world evidence
  4. Expedited review pathways
  5. Biosimilars
  6. Quality
  7. Pharmacovigilance
  8. FDA and pricing reform
  9. Opioids and pain management
  10. Facilitating innovation
  11. Transparency initiatives
  12. Social media policy
  13. Regulated and non-regulated healthcare apps

Who will benefit:

Below personnel working in pharma, biotech, medical device, app development, marketing and communications firms etc. will be benefited:

  1. Product managers
  2. Public policy developers
  3. Communications and marketing specialists
  4. Regulatory and legal departments
  5. C-suite advisors
  6. Investors
  7. Social media strategists
  8. App developers
  9. Healthcare consultants

Why you should register:

Dr. Gottlieb's intimate knowledge of the health industry psyche, viewed by some as his greatest flaw - is actually his most unique and important asset. He recognizes that predictability is power in pursuit of the public health and, in imagining an FDA that can (indeed must!) color outside the lines, pays heed to Bertrand Russell's maxim that, "Science may set limits to knowledge, but should not set limits to imagination."

Topic Background:

Scott Gottlieb's tenure as Food and Drug Administration commissioner has, to date, been defined by two terms not generally associated with the agency that regulates more than a third of the U.S. economy - predictability and imagination.

"Imagination" and "Regulatory Policy" are not often used in the same sentence. But, the Gottlieb FDA is changing that. He recognizes that the agency must advance their relationships with the industries it regulates. That doesn't mean fewer in-depth reviews or strident actions. What it does mean is that the FDA is doing a better job being a first-among-equals intramural partner. From patient-focused drug development to biomarker vetting, responsible off-label communications, new approaches to pain management, and the regulatory science required for validating real-world evidence, Gottlieb is steadily moving the agency away from its traditional angst in "not invented here" regulatory conversations. He's not only imagining an FDA that is both regulator of and colleague with industry; he's working to make it a reality.

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