Phase I GMPs clinical trials - 2017

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 trials

Key elements and Best practices of GMP for Phase I clinical trials

IND content and format for CMC information

Who Will Benefit:

Directors

Managers/Supervisors

Regulatory Affairs

Manufacturing

Quality Assurance and Clinical Operation

Contact Detail:

Compliance4All DBA NetZealous,

Phone: +1-800-447-9407

Email: support@compliance4All.com

Speaker 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.