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From Drug Discovery to Drug Approval:
A Seminar Series on Working with the FDA
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In wake of a renewed regulatory climate for drug safety, the Food and Drug Administration (FDA), as mandated by Congress through the Food and Drug Administration Amendments Act (FDAAA), and implemented through the “Safety First, Safe Use” initiative, the FDA is undergoing organizational structure and staffing practice changes to meet these new demands. How is the FDAAA going to impact the pre- and post- market review processes, as well as the prescription drug user fee program (PDUF), the transparency and predictability of which have been crucial to drug companies and the investment community who funds drug discovery?
The process of drug discovery and development involves a complex interplay among researchers, legal experts, business management teams, investors and regulatory agencies. We are honored to be in collaboration with CURE and bring together these diverse professionals to discuss various aspects of the drug development process, ranging from generating pre-clinical data, filing a new drug application, managing clinical trials, to marketing the drug both nationally and globally, and creating value for investors.
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Seminars
**Download the flier**
All Events will take place at Yale Anlyan Center TAC Auditorium (N107)
4:30 - 5:00 PM Registration
5:00 - 6:00 PM Panel Discussion
6:00 - 7:00 PM Networking
Perspectives from the FDA: FDA organization, Phases, Future
Date: October 22nd, 2008
Panelists:
M. Yebba: Sr. Public Affairs Specialist, FDA
M. Haggerty: Drug Investigator, FDA
Perspective from the Pharmaceutical Industry : IND submission, NDA approval
Date: October 29th, 2008
Panelists:
Dr. M. Garvey: Director of Worldwide Regulatory Strategy & Registration, Pfizer
Dr. C. Burgess : Associate Director – Regulatory Oncology, Bristol-Myers Squibb
Dr. G. Shah: Senior Vice President and Chief Compliance Officer, Achillion Pharmaceuticals.
Intellectual Property Issues
Date: November 4th, 2008
Panelists:
Vern Norviel, Partner, WSGR - Click to download presentation
Jon Nygaard, FDA specialist, WSGR - Click to download presentation
Participating Companies and Organizations
Event Sponsors:
Participating Organizations:
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