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Session 10: Telemedicine, Intended Use, and the Art of Staying Compliant
Session Chair(s)
Darshan Kulkarni, JD, PharmD, MS
Principal Attorney
Kulkarni Law Firm, PC, United States
This interactive 75-minute session tackles the legal and compliance challenges that life sciences companies face when building pre-commercial strategies. We’ll explore where disease awareness campaigns cross the line into promotion, how ad promo teams can shape development from TPP through Phase IV, and the evolving risks tied to telemedicine, Intended Use, and blurred roles between medical and commercial teams. Through real-world case studies, participants will learn to spot red flags and apply practical safeguards before a launch goes off track.
Learning Objective : - Apply FDA, DOJ, SEC and OIG expectations to pre-commercial efforts, including Intended Use guidance and telemedicine marketing
- Evaluate how adpromo input from early development strengthens compliance and market readiness
- Recognize risk points when medical affairs and commercial teams overlap
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Practice compliance decision-making through interactive case scenarios adapted from real enforcement and legal actions
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