Medical Science Liaison Compliance Primer
MSL compliance is tricky business: navigating the gray areas of medical science liaison program compliance and activity compliance requires you not only to seek the right expert the ask your questions, but to know what questions to ask. This webinar contains a primer of the most commonly asked questions (or FAQ, frequently asked questions) in MSL compliance, posed by Dr. Jane Chin to Mr. Alan Minsk, a well known expert in the legal and regulatory landmines in MSL compliance. A critical primer for MSL directors, Compliance officers, and corporate legal counsel tasked with guiding the organization’s MSL teams through stormy compliance waters.
Track 001 [02:03] Legal and compliance issues affecting MSL programs
Track 002 [03:46] Scientific exchange v. Promotion
Track 003 [00:53] FDA Regulations relating to Off-Label Promotion v. Scientific Exchange
Track 004 [01:55] Proactive v. Reactive MSL Activities
Track 005 [07:15] Early Commercialization v. Scientific Exchange
Track 006 [02:32] Off-Label in a Peri-Label Situation
Track 007 [02:21] Off-Label issues in Medical Device
Track 008 [01:36] Compliance Considerations in Medical Device
Track 009 [03:24] How Companies Know They’re in Trouble
Track 010 [02:46] What May be Audited in MSL Programs
Track 011 [03:18] Former Sales Reps as MSLs and the MSL Mindset
Track 012 [02:36] MSL Attitudes Toward Compliance
Track 013 [03:02] MSL Metrics in a Compliant Environment
Track 014 [04:52] When Do Companies Seek Outside Counsel?
Track 015 [06:46] Questions For Prospective Outside Counsel
Track 016 [02:28] Alan’s Parting Words of Wisdom
Format: Multimedia CD-ROM, 52 Minutes
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