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Dec 09, 2015 11:30 AM - Dec 09, 2015 1:00 PM

(Eastern Standard Time)

Online

Amarin vs. FDA: What is the Future of Off-Label Drug Communication and What Can We Do Now?

Presenters

Tracy  Rockney, JD

Tracy Rockney, JD

Co-Founder and Managing Partner, Onesource Regulatory, United States

Tracy Rockney is a respected regulatory leader with more than 20 years of experience in the pharmaceutical industry. She is the Co-founder and Managing Partner at OneSource Regulatory, a consulting firm specializing in Regulatory Advertising & Promotion, Medical Review, Labeling Development and Healthcare Compliance. Tracy received her JD from Washburn University School of Law, and her BA from the University at Albany, SUNY, Rockefeller College of Public Affairs & Policy. Tracy is a board advisor and Regulatory Officer in Residence for Doctor Evidence, a specialty software platform and services company that transforms clinical studies, drug labeling and epidemiological databases into reusable dynamic relational databases.

Joy  Liu, JD

Joy Liu, JD

Partner, Ropes and Gray, United States

Joy Liu advises drug, biotech, and device companies on a broad range of FDA regulatory matters. Joy has significant experience working on advertising and promotion compliance matters, Hatch-Waxman patent and exclusivity issues, and regulatory risk management. She has also worked on numerous government investigations and gained experience as in-house product attorney while on secondment to two pharmaceutical companies. Joy serves on the Board of Directors of the Food and Drug Law Institute.

Darshan  Kulkarni, JD, PHARMD, MS, RPH

Darshan Kulkarni, JD, PHARMD, MS, RPH

Principal Attorney, Kulkarni Law Firm, PC, United States

Darshan Kulkarni is a pharmacist-attorney at the Kulkarni Law firm and advises life sciences companies on promotional compliance and medical affairs strategy. He works with pharmaceutical and medical device teams on FDA advertising rules, OPDP risk, influencer and digital promotion, speaker programs, scientific exchange, HCEI communications, and field medical guardrails. Drawing on hands-on experience in compliance, clinical research, and regulatory strategy, he helps companies design review processes, train commercial and medical teams, and navigate enforcement risk while preserving scientific integrity and business objectives.

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