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Virtual

Mar 05, 2021 10:00 AM - Mar 05, 2021 3:00 PM

Drug and Medical Device Ad Promo Primer

Instructors

Dale  Cooke, JD, MA

Dale Cooke, JD, MA

President, FDA Ad Law, United States

Dale Cooke is president of PhillyCooke Consulting, which helps prescription product marketers use 21st century technology to provide healthcare information while ensuring compliance with FDA regulations written in the 1960s. Dale is the author of Effective Review & Approval of Digital Promotional Tactics, now in its second edition, which was published by the Food & Drug Law Institute.

Kevin  Madagan, JD

Kevin Madagan, JD

Partner, Reed Smith, LLP, United States

Kevin is a health care attorney and member of Reed Smith’s Life Sciences Health Industry Group. He advises clients across the life sciences and health care spectrum about FDA regulatory issues related to the manufacturing, distribution, and sale of drugs (Rx, OTC, homeopathic), biologics, devices (Rx and OTC), and dietary supplements. Kevin specializes in providing legal and strategic advice regarding advertising and promotion, FDA enforcement, and supply chain logistics. Among other things, Kevin has spent the last 15+ years advising compliance teams and serving as legal counsel to startup and global drug and medical device clients.

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.

Julia  Lake, JD

Julia Lake, JD

Associate, Reed Smith, LLP, United States

Julia is an associate in Reed Smith’s Life Sciences Health Industry Group in the firm’s Philadelphia office. Her practice is split between litigation and regulatory matters for life sciences clients, including a specialization in providing legal and strategic advice regarding advertising and promotion. Most recently, Julia was seconded to a life sciences client and provided full-time ad-hoc legal support to several commercial brands and sat on promotional and non-promotional review committees.

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