For years now, the American Conference Institute (“ACI”) has put on a series of excellent FDA-related conferences. Those of us in the Hatch-Waxman world look forward to attending the popular annual Paragraph IV Disputes, Maximizing Pharmaceutical Patent Life Cycles, and Hatch-Waxman Boot Camp conferences. They are a kind of “family reunion” – a “Cheers”-type atmosphere where everyone knows your name.
The latest conference to be added to the ACI lineup is the Legal and Regulatory Summit on Generic Drugs, which will take place on Wednesday, July 17 to Thursday, July 18, 2013 in New York City. Developed as a “state of the union” of the legal and regulatory – as well as political and global – changes affecting the generic pharmaceutical industry, the conference is sure to be the banner conference of the summer.
Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst (author of the latest edition of Generic and Innovator Drugs: A Guide to FDA Approval Requirements) and Seyfarth Shaw LLP’s Shashank Upadhye (author of Generic Pharmaceutical Patent and FDA Law) are co-chairing the conference. (And, yes, they’ll probably be hawking their books at the conference.)
Importantly, the Summit on Generic Drugs is not designed to be a rehash of issues and topics discussed at other Hatch-Waxman-related conferences. Presenters will delve into generic drug politics, the Generic Drug User Fee Amendments (“GDUFA”), and much, much more. Take, for example, the panel discussion on Insights From the Office of Generic Drugs. The panelists – Gary Buehler, Gordon Johnston, and David Rosen – have more than 30 years of experience working at FDA in the Office of Generic Drugs. Their perspectives on how the Office has changed over the years, how the Office operates, and future challenges with GDUFA and recent reorganizations are something folks cannot get in another venue.
To obtain a copy of the conference brochure and to register for the event, please visit ACI's website. FDA Law Blog is a conference media partner. As such, we can offer FDA Law Blog readers a special $200 discount. The discount code is: FLB200. We look forward to seeing you at the conference.