The End-of-Phase 2 FDA meeting is the optimum time to obtain FDA input at a single Type B meeting on the remaining pharmacology and toxicology studies, chemistry manufacturing and controls (CMC) of the clinical formulation, and the overall IND clinical plan to support an NDA submission for market approval. Therefore, it is essential to give proper forethought and attention to the all-important steps in preparing for the EOP-2 FDA meeting.

In this conference our speaker, veteran industry expert Dr. Larry Hofmann, gives expert guidance on the optimum background and makeup of your EOP-2 FDA meeting team. He also discusses strategic planning for and preparation of the FDA meeting information package, which must include available pharmacology and toxicology, Phase 1 and Phase 2 study summaries, as well as a summary of CMC data on the previous IND clinical formulations and proposed Phase 3 formulation to support the proposed Phase 3 and remaining Phase 1 study protocols.

This audio conference covers:

• Interacting with the FDA and preparing the formal request for the EOP-2 meeting
• A template of 13 key planning steps to complete for timely preparation of the meeting information package
• Key goals of an FDA EOP-2 meeting
• FDA and ICH guidance documents to assure preparation of a detailed EOP-2 meeting information package

About the speaker:

Dr. Larry Hofmann has 25 years of experience in clinical research at the associate director and director level at three pharmaceutical companies -- Adria Labs, Parke-Davis and Schwarz Pharma -- as well as a medical device company, Kendall Healthcare Products. He has been the medical monitor for 12 INDs and project team leader for 8 IND/NDA programs with team success in obtaining FDA approval of 8 NDAs for marketed drugs and several medical devices.

Dr. Hofmann has overseen FDA meetings at six CDER divisions, including pre-IND, End-of-Phase 2 and Pre-NDA filing meetings. The last EOP-2 meeting led to FDA approval of the remaining protocols for a completed IND clinical plan: two Phase 3 protocols and the remaining Phase 1 drug x drug pharmacokinetic/metabolism interaction protocols to support an NDA submission for market approval. As president of LMH Associates, he currently provides independent clinical operations and regulatory affairs consultation for pharmaceutical and medical device companies.

Who should attend?

• Regulatory Affairs Managers/Directors
• Research & Development Directors (Toxicologists, Pharmacologists)
• Clinical Research Managers/Directors
• Medical Monitors
• IND Project Managers and Directors
• Biopharmaceutics & Pharmacokinetics Scientists

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.