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Advertising and Promotion Regulatory Affairs Conference

This event is now offered in a new entirely virtual format.


Session 10: Track B: Promotion and What Rules Apply to Generic Drugs and Biosimilars

Session Chair(s)

Cheryl Y Roberts, JD, MS

Cheryl Y Roberts, JD, MS

  • Sr. Director Regulatory Affairs Lead
  • Mylan, United States
As generic and biosimilar drug promotion becomes more prolific, this session will cover the rules of the road for promotional review committees charged with overseeing promotional materials and media for generic drugs and biosimilars. This session will review the regulatory landscape, new guidances, do’s and don’ts, common pitfalls, and the enforcement landscape surrounding generic and biosimilar drug promotion. Attendees will gain insights into key regulatory considerations and factors that should guide their review of generic and biosimilar drug promotional materials, across a range of media.
Learning Objective :

At the conclusion of this session, the participant should be able to:

  • Discuss Rules of the Road in Generic Drugs and Biosimilars Promotion
  • Understand the Do’s and Don’ts in Biosimilars Promotion
  • Identify Common Pitfalls in Generic Drug Promotion
  • Discuss the latest FDA guidance on Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products

Speaker(s)

Marci  Schentzel, PharmD

Promoting a Biosimilar Product: Explore the Nuts and Bolts

Marci Schentzel, PharmD

  • Senior Director, Regulatory Affairs
  • Mylan, United States
Julie  Tibbets, JD

Avoiding the Pitfalls of Generic Drug Promotion

Julie Tibbets, JD

  • Partner
  • Goodwin Procter LLP, United States

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