American Conference Institute's Legal and Regulatory Summit on Generic Drugs, the exclusive forum designed to address and provide solutions for the generic pharmaceutical industry's present and future challenges, will take place on July 17-18 in New York, NY.
James Peterka will speak on the topic of "The Game Changer: Analyzing the Legal and Business Impact of the Generic Drug User Fee Amendments" at 9:15 a.m. on July 17. This topic will cover:
- Parsing the full scope of GDUFA - the import of GDUFA's inclusion in the FDA Safety and Innovation Act (FDASIA)
- Implementation growing pains - what has been implemented so far, problem areas, and what remains
- How leadership changes at Office of Generic Drugs (OGD) will impact administration and further implementation of GDUFA
- Effect of smaller and foreign companies maneuvering around possible trade barriers and should smaller companies expect to be "pushed out"
- Analyzing GDUFA's impact on the cost of business
- Experiences with GDUFA and lessons learned
David Abramowitz will be speaking on the topic of "The Evolution of Authorized Generics Agreements Including New Controversies Under Health Care Reform" at 4:00 p.m. on July 17. This topic will provide advice on:
- Permissible terms of authorized generic agreements
- Parsing the issues that overlay contract manufacturing arrangements
- Examining the pending new restrictions posed by the Affordable Care Act - brand treatment for authorized generics with respect to reimbursement and payment in government payor programs
Visit the American Conference Institute's website for more information on this event.