- Monday, October 2, 2023
- Tuesday, October 3, 2023
- Wednesday, October 4, 2023
Join us to learn more about USP’s efforts to support generic manufacturers bringing quality medicines to market. The Forum will feature insights from USP’s CEO as well as other senior industry leaders, as well as how standards and other USP resources may be used to respond to industry challenges surrounding mitigation of impurities and creating efficiencies in the development of sterile injectables.
Ronald T. Piervincenzi, PhD
Chief Executive Officer, U.S. Pharmacopeia
Anthony Lakavage, J.D.
Senior Vice President, Global External Affairs, U.S. Pharmacopeia
Desmond Hunt, PhD
Senior Principal Scientist, U.S. Pharmacopeia
Rebecca Cambronero, MBA, MSL, PMP
Senior Director, Regional General Manager, North America, U.S. Pharmacopeia
Michael Eakins, PhD
Principal Consultant, Eakins & Associates
Vice-Chair, USP General Chapters Packaging and Distribution Expert Committee
Mark Schweitzer, PhD
Principal, Mark Schweitzer Consulting, LLC
Chair, USP Microbiology Expert Committee
Maryll Toufanian, J.D.
Senior Vice President, Regulatory Strategy and Government Affairs, Amneal Pharmaceuticals
Kiran Krishnan, PhD
Senior Vice President| Global Regulatory Affairs, Apotex Corp.
Welcome to the conference’s opening networking reception, proudly sponsored by USP. Kickstart your experience by mingling with fellow attendees, industry experts, and thought leaders. This is the perfect chance to connect, exchange ideas, and build new relationships
Science and Regulatory Working Group
AAM Members Only
An interactive knowledge sharing session that brings together multiple levels of scientific, regulatory and policy disciplines from diverse sectors, industry, academia and health authorities. The expo is geared toward facilitating one-on-one interaction among these sectors to increase understanding and knowledge sharing. This year’s expo will also feature over 50 project managers from FDA’s OGD and OPQ who will participate in an information exchange opportunity with attendees.
- Office of Generic Drugs (OGD)
- Office of Pharmaceutical Quality (OPQ)
- Drug Shortage Staff (DSS)
- Office of Compliance – Exports, Imports, and Recalls
- FDA Electronic Submissions – What’s New?
- OM Division of User Fee Management
- Injectable Drugs Deficiency Trend Analysis
- Product Marketing and Supply Notifications
- Regulatory Requirements and Challenges – High Molecular Weight Species in Peptides: Process Considerations, Characterization and Regulatory Requirements for an ANDA
- The cumulative impact of developments in the environmental regulation of PFAS and pharmaceutical propellants
- GDUFA Science and Research Program
- Benefits of the SD File Format
- Exception Excipients and pH adjusters: Controlled Correspondences
- Post approval changes on complex generic and respiratory products
- Nitrosamines in Pharmaceuticals – What does the future look like?
- FDA Careers
Click here for more information
Biosimilars Council Meeting
Biosimilars Council Members Only
Depart for Offsite Dinner
GRx+Biosims Dinner & Entertainment
Join us for a festive evening of dinner and entertainment at Sports & Social Bethesda. Enjoy the sports tavern ambiance and timeless games, along with delicious food options. We’ll unwind, network, and have fun with live entertainment that will add a unique twist to your conference experience. Don’t miss the opportunity to connect, relax, and have a fantastic time at this engaging venue.
GRx+Biosims 2023 Concludes
*Agenda is subject to change