Phase I GMPs clinical trials - 2017
The studies are generally small number of healthy subjects and use lower doses of the drug product
Mon, May 15, 2017 10:00 AM (PDT)
Online,
Fremont,
California
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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
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.
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com
Full Details & Registration Link: http://www.compliance4all.com/control/w_product/~product_id=501228LIVE?channel=ticketprinting_May_2017_SEO
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
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.
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com
Full Details & Registration Link: http://www.compliance4all.com/control/w_product/~product_id=501228LIVE?channel=ticketprinting_May_2017_SEO
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