As in previous years, our speakers will include in-house counsel, industry professionals and Reed Smith lawyers representing a cross-section of the industry. A link to the conference agenda can be found below.

Featuring Keynote Speaker – José Morey, M.D.

José is Chief Executive Officer and Founder of Ad Astra Media LLC, an Eisenhower Fellow, and Co-Founder of Ever Medical Technologies. He is a health and technology keynote speaker, author, and consultant for NASA, Forbes, MIT, the United Nations World Food Program and the White House Office of Science and Technology Policy.

Sessions will include:

• Lunch Fireside Chat: Beyond the Breach: Safeguarding Healthcare Data in the Digital Age
• FDA’s Latest Draft Guidance on Off-Label Communications – Inching Closer to Truth as a Viable Guiding Principle for Addressing Off-Label Information from Regulated Manufacturers
• Risk, Reward, and Mitigation: Adapting Business Strategies in the Current Enforcement Environment
• Enforcement Trends in the Pharmacy Industry: What You Need to Know
• State of Play: FDA Enforcement and Transactional Considerations in the Biotech and Digital Health Industries

This program is presumptively approved for 4.0 CLE credits in California, Illinois, New Jersey, New York, Pennsylvania, Texas, and West Virginia.  Applications will be filed in Delaware, Florida, Ohio, and Virginia. Attendees who are licensed in other jurisdictions will receive a uniform certificate of attendance, but Reed Smith only provides credit for the states listed.

We look forward to seeing you again!

A block of rooms has been reserved at the Hamilton Hotel for this event. If you’d like to book a room, the hotel reservation link will be in provided in your registration confirmation email.

View the full agenda.