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  5. CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Draft Guidance for Industry on Safety Assessment for IND Safety Reporting - February 1, 2016
  1. Development & Approval Process (Drugs)

CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Draft Guidance for Industry on Safety Assessment for IND Safety Reporting - February 1, 2016

CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Draft Guidance for Industry on Safety Assessment for IND Safety Reporting - February 1, 2016

The Food and Drug Administration, Center for Drug Evaluation and Research Small Business and Industry Assistance (CDER SBIA) is pleased to inform you of a unique opportunity for small business and industry entities to learn more about the FDA and basic drug regulation. Our webinar series highlights various aspects of drug regulation.

These events focus on a specific topic and provide an opportunity for small business and industry entities to learn more about the FDA and basic drug regulation. The webinars support CDER SBIA’s mission of promoting productive interaction with regulated industry by assisting small pharmaceutical business and industry with information relating to the development and regulation of human drug products.

On February 1, 2016, CDER hosted a LIVE webinar titled: "Draft Guidance for Industry on Safety Assessment for IND Safety Reporting."

This one hour webinar:

  • Provided recommendations for how sponsors of INDs can identify and evaluate important safety information that must be submitted to FDA and all participating investigators under the IND safety reporting regulations at 21 CFR 312.32.
  • Discussed the draft guidance recommendations for a systematic approach to IND safety reporting, including the composition and role of a safety assessment committee, aggregate analyses for comparison of adverse event rates across treatment groups, planned unblinding of safety data, reporting thresholds for IND safety reporting, and the development of a safety surveillance plan.
 
Our featured speaker was:
 
Robert Temple, M.D.,
Deputy Center Director for Clinical Science
Center for Drug Evaluation and Research (CDER)
 
Robert Temple serves as CDER’s Deputy Center Director for Clinical Science and also Acting Deputy Director of the Office of Drug Evaluation I (ODE-I). He has served in this capacity since the office's establishment in 1995. Dr. Temple received his medical degree from the New York University School of Medicine in 1967. In 1972 he joined CDER as a review Medical Officer in the Division of Metabolic and Endocrine Drug Products. He later moved into the position of Director of the Division of Cardio-Renal Drug Products.
 
In his current position, Dr. Temple oversees ODE-1 which is responsible for the regulation of cardio-renal, neuropharmacologic, and psychopharmacologic drug products. Dr. Temple has a long-standing interest in the design and conduct of clinical trials. He has written extensively on this subject, especially on choice of control group in clinical trials, evaluation of active control trials, trials to evaluate dose-response, and trials using “enrichment” designs.

 

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