FDA End-of-Phase 2 IND Meeting: Finalizing the IND Clinical Plan

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.

FDA End-of-Phase 2 IND Meeting: Finalizing the IND Clinical Plan is being presented by Dr. Larry Hofmann, President, of LMH Associates, Inc. and airs on Tuesday, November 3, 2009. For more information, or to register for this event please visit our site at www.fxconferences.com

The Pre-IND Program: 12 Steps to a Successful IND Filing

The Pre-IND phase of drug development is the foundation upon which all subsequent IND research depends, in order to obtain FDA market approval (NDA) after completion of required Phase 1-3 trials. Therefore, it is essential to give proper forethought and attention to these first, all-important steps. This audio conference looks at the 12 essential steps to complete during the Pre-IND phase of development leading to the filing of an original IND with the goal of obtaining FDA approval for initial Phase 1 clinical trials.

Our speaker, veteran industry expert Dr. Larry Hofmann, will give expert guidance on the optimum background and make-up of your pre-IND development team. He will also discuss strategic planning for and preparation of the FDA meeting information package -- provided to the FDA reviewing division 30 days prior to the pre-IND meeting -- which must include available pharmacology and toxicology summaries, as well as a summary of CMC data on the IND clinical formulation to support the proposed Phase 1 and Phase 2a study protocols.

The Pre-IND Program: 12 Steps to a Successful IND Filing is being presented by Dr. Larry Hofmann, President, with LMH Associates, Inc. and airs on Tuesday, March 31th, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

This audio conference has been pre-approved by RAPS as eligible for one (1) credit toward a participant's RAC recertification upon completion.