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Topics in Legal Affairs
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Topics in Legal Affairs

Publisher: FX Conferences
  • Description

Stay current on a broad range of topics in legal affairs with 10 audio recordings of industry experts offering practical guidance and insight.

Ovid and FX Conferences offer thousands of professional development hours for your teams, conveniently packaged and delivered as a collection of audio recordings to save you time and money.

Topics in this collection have a global appeal and are relevant for multiple departments within your organization—R & D, Market Research, Compliance, and more. Each of the 10 recordings consists of a 45-minute, telephone-based presentation delivered by expert international speakers, followed by a 15-minute question-and-answer session (collection available with and without transcripts).


1. Requests for Off-label Information – The FDA Guidance and Its Implications
Speakers: Wendy Blackburn, Executive Vice President, Intouch Solutions and Dr. Darshan Kulkarni, Principle Attorney, The Kulkarni Law Firm

2. Managing the Litigation Risks Arising from FDA Actions
Speakers: Kelly Savage Day and Carol Brophy, Sedgwick LLP

3. Meeting New Transparency Requirements and Implementing a Scalable Aggregate Spend Solution
Speakers: John P. Oroho, Principal and Kiaema R. Reid, Senior Regulatory Analyst, Porzio Bromberg & Newman, PC

4. Off-label Investigations: Recent Actions, Settlements and Enforcement Trends
Speakers: John E. Kelly, Partner and Cori Annapolen Goldberg, Senior Associate, Fulbright & Jaworski LLP

5. Off-Label Marketing Enforcement and Risks for Medical Device Companies and Service Providers
Speakers: Michael Volkov and Michael Ruggio, Partners, LeClair Ryan

6. Who Owns What? Patent Ownership Issues with the Exchange of Biotechnology
Speaker: Kattina V. Barsik, Intellectual Property and Registered Patent Attorney

7. FDA Imports: How to Deal with Holds, Detentions and Refusals
Speaker: Kyle Sampson, Partner, Hunton & Williams LLP

8. FDA Update – Responding to Unsolicited Requests for Off-Label Information
Speakers: Marian J. Lee, Partner, and Beverly H. Lorell, Senior Adviser, King & Spalding LLP

9. Off-label Promotion – What FDA Looks For & What You Need to Know
Speaker: Alan Minsk, Partner, Arnall Golden Gregory LLP

10. Successfully Responding to FDA 483s and Warning Letters
Speaker: Michael A. Swit, Special Counsel, FDA Practice, Duane Morris LLP

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