RIC Annual Meeting Program

8:30 - 5:30pm Registration  
9:00 - 9:15am Welcome & Opening Remarks Kevin Holman, MBA RAC
Janssen Pharmaceutical Companies of Johnson & Johnson
Chairman of the RIC Board of Directors
9:15 - 10:30am Opening Panel: Why RIC, Why NOW?

Linda Pissott Reig, Moderator
Buchanan, Ingersoll & Rooney PC
Kevin Holman
Janssen Pharmaceutical Companies
of Johnson & Johnson
Michael Cheung
Bristol-Myers Squibb
Jennifer Church
Viatris
Kal Elhoregy, RPh, PA
Amneal Pharmaceuticals, Inc.
Kishore Gopu
Teva Pharmaceutical Industries Ltd.
Sherice Mills
Jazz Pharmaceuticals

10:30 - 11:00am Coffee Break & Networking  
11:00 - 12:00pm Stakeholder Feedback on REMS Functionality and Operability

Jason Ancell
Gilead Sciences

Sherice Mills
Jazz Pharmaceuticals

12:00 - 1:00pm Lunch & Networking  
1:00 - 2:00pm REMS Data Standardization: Codex
Challenges & Opportunities
Kelee Petzelt
Point-of-Care Partners
Edward Millikan, PharmD
FDA (invited)
2:00 - 2:45pm REMS-Related Regulatory & Legislative Update Brianna Gallagher, Moderator
Viatris
2:45 - 3:15pm Break  
3:15 - 4:15 pm Is Your REMS Ready for Release?

Jason Ancell, Moderator
Gilead Sciences

4:15 - 4:30 PM Closing Remarks Kevin Holman, MBA RAC
Chairman of the RIC Board of Directors
5:00 - 6:30 PM Reception & Networking Assembly (1700 N Moore St, Arlington, VA 22209)  Right next door to Convene  

Day 2 March 23, 2023

8:30 - 9:00am Breakfast  
9:00 - 9:45am RIC Membership Business Meeting
(To include all voting and non-voting members)
 
9:45 - 10:30am The Regulator's View Elaine Lippmann, JD
FDA (Invited)
10:30 - 10:45am Coffee Break & Networking  
10:45 - 11:30am Global Safety Surveillance

Linda Pissott Reig, Moderator
Buchanan, Ingersoll & Rooney PC
Jamie Wilkins 
Pfizer
Tracy Hernandez
Bristol Meyers Squibb

11:30 - 12:15pm

Current State of REMS Initiatives

Claudia Manzo, PharmD
FDA (Invited)
Edward Millikan, PharmD
FDA (invited)

12:15 - 1:15pm Lunch & Networking  
1:15 - 2:00pm Technology: Are we asking the right questions? Kyle Irwin, Moderator
Janssen Pharmaceutical Companies
of Johnson & Johnson
2:00 - 2:30pm Wrap-Up & Call to Future Action Kevin Holman, MBA RAC
Chairman of the RIC Board of Directors