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Virtual Seminar on Phase I GMPs

Event Details

Virtual Seminar on Phase I GMPs

Time: February 8, 2019 from 8am to 11am
Location: Fremont
Street: 161 Mission Falls Lane, Suite 216,
City/Town: Fremont
Website or Map: http://www.globalcompliancepa…
Phone: 18004479407
Event Type: virtual, seminar
Organized By: John Robinson
Latest Activity: Jan 21, 2019

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Event Description

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.  Therefore, only small amounts of investigational material are required. In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has established guidelines to allow early stage investigational products to be manufactured under less stringent GMPs.

This workshop will review the current regulations, guidance documents for early stage manufacturing and GMPs in detail.  Regulatory strategies and logistical considerations for early development stage product, including vendor selection and management, stability, labeling, and documentation requirements will also be reviewed and explored.

Why you should 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.

Who Will Benefit

  • Directors
  • Managers
  • Supervisors in Regulatory Affairs
  • Manufacturing
  • Quality Assurance
  • Clinical Operations

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. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014). 

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