Food & Drug Regulation

Good Clinical Practice for Sponsors of Clinical Trials

Presented by Mary Bernadette Ott
Recorded On: Tuesday, October 09, 2012
Duration: 90 minutes
PURCHASE:
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By Phone: 1-800-677-3789
RECORDING HIGHLIGHTS:

Implementing Good Clinical Practice regulations is imperative for successful clinical trials.

Register today for this 90-minute webinar and ensure you have an understanding of the Good Clinical Practice (GCP) regulations so that you can avoid negative inspection results. These guidelines (21CFR Part 54, Part 312 and Part 812 and ICH GCP Guideline) outline Sponsor responsibilities in conducting clinical trials, and they are many and they are varied.

Key Learning Points:

• What are the GCP regulations for sponsors?
• What happens when a sponsor transfers some or all of their obligations to a CRO?
• What reports must a sponsor submit and within what timeframes?
• What are the financial disclosure requirements for clinical trials?
• What determines that an investigator is qualified to conduct a clinical trial?

Register today and receive strategies for complying with these regulations and get the information you need to avoid negative inspection results
 

YOUR EXPERT(S):
Mary Bernadette Ott

Mary Bernadette Ott is a GCP compliance consultant, conducting sponsor/monitor audits and clinical investigator site audits for numerous pharmaceutical, biotechnology and medical device companies. She has audited IRBs, central laboratories, central reading facilities, CROs, and Phase I clinical units.  She frequently conducts GCP classes for individual companies, as well as for DIA, ACRP, and other trade groups.

 

Previously, Bernadette served with the FDA as a field investigator in the Philadelphia District Office, and as a supervisor in the Boston District Office. There she was responsible for evaluating food, drug and device companies in the areas of GMP, GCP and GLP compliance.

 

Bernadette is co-author of Guide to Good Clinical Practice, published by Thompson.

 



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