Tuesday, 24 May 2005: 1:30 PM-5:00 PM

Room 212 (Science & Engineering Resource Center)

Chemistry and the Law (CHAL)

Regulatory and Patent Law – the Scientist’s Perspective

Scientists are challenged, not only by the complexities of the technical problems they are working to solve, but also by the regulatory and legal environment. This is especially true in industry and academia where concerns for regulatory compliance and protection of intellectual property (IP) impact the bottom line of the corporate or academic sponsor. In this session, two of our speakers will update scientists on what they need to know today to protect the IP rights. This session will also strengthen the drug substance development chemist with knowledge regarding manufacturing and laboratory practices for thriving under a complex regulatory environment.
Organizers:Leticia Quinones
Jay M. Brown
Presiders:Jay M. Brown
Leticia Quinones
1:30 PM Introductory Remarks
1:35 PM Title: Strategies for Writing Effective Global Patent Applications and Developing Technology
Rosemary M. Miano
2:15 PM Current Developments in Federal Circuit Court Decisions on Patent Law: What Scientists Need to Know
Jay M. Brown
2:55 PM Break
3:10 PM Contrasting GMP and GLP Requirements for Pharmaceutical Development API Supplies
David Kunzinger
3:50 PM FDA and PhRMA's Current Thinking on Starting Materials
Sandeep, P. Modi

Back to The 37th Middle Atlantic Regional Meeting (May 22-25, 2005)