Phase I GMPs clinical trials - 2017
- Start Date:
- Tuesday, 16 May, 2017
- End Date:
- Tuesday, 16 May, 2017 11:30am
- Business Practice, Health & Nutrition
Overview: Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product.Why should you Attend:Attend this conference so that you may understand differences between GMP requirements for early and later stage clinical development. Explore and discuss ways to develop and implement strategies for early GMPs for phase I clinical studies.
Areas Covered in the Session:FDA regulations and Guidance Documents for Phase I clinical trialsKey elements and Best practices of GMP for Phase I clinical trialsIND content and format for CMC informationWho Will Benefit:DirectorsManagers/SupervisorsRegulatory AffairsManufacturingQuality Assurance and Clinical OperationSpeaker Profile:Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics.Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: support@compliance4All.com
161 Mission Falls Lane,
Conference organized by Compliance4ALL
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. .Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
- 161 Mission Falls Lane, Suite 216