Recognizing and Responding to "Red Flags" in Clinical Operations

In this webinar, learn about the several regulatory requirements sponsors need to comply with for the development of the drug product. These requirements expand to include interaction with other regulatory agencies, both Federal and State. The post-marketing obligations encompass more functional areas of the company; including sales and marketing, medical affairs, and external spokespersons.

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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
Instructor Profile:
Peggy Berry Peggy Berry

Founder, Synergy Consulting LLC

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, she was Vice President of Regulatory Affairs at Insmed where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. She also worked as Vice President of Regulatory Affairs and Quality at Amarin and held a variety of senior level positions at Dyax, MGI Pharma, AstraZeneca and Dey Pharma. She has also held Regulatory Affairs roles within two clinical contract research organizations and has worked in review divisions at the FDA. In addition, Ms. Berry is active in the Regulatory Affairs Professionals Society. She is an editor-in-chief of Fundamentals of US Regulatory Affairs, 6th edition (RAPS, MD 2010). Editor of “Choosing the Right Regulatory Career” (RAPS, MD 2010) and author of “Communication & Negotiation” (RAPS, MD 2011).

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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