Recognizing and Responding to "Red Flags" in Clinical Operations

Peggy J Berry

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Sponsors need to comply with various legal requirements for drug product development. These include communications with Federal and State Regulatory agencies. The post-marketing requirements include more functional areas of the company such as sales and marketing, medical affairs, and external spokespersons.

Why Should You Attend:

Attend this webinar to learn the regulatory obligations and related timing for those activities.

Includes details regarding:

  • Drug listing
  • Pediatric studies
  • Advertising submissions (US)
  • Annual Reports
  • Periodic Safety Update Reports
  • Pharmacovigilance
  • Supplements/Variations
  • Renewals (EU)
  • Commitments
  • Interaction with other Agencies

Areas Covered in the Webinar:

  • FDA Requirements
    • Regulatory
    • Pharmacovigilance
    • Manufacturing
    • Sales & Marketing
    • Medical Affairs
    • Quality
  • Requirements of other agencies
    • State
    • Federal

Who Will Benefit:

  • Associates, Specialists, Managers, Associate Directors, Directors of US Pharma Industry
Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Peggy J Berry,

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).

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