Good Manufacturing Practices (GMPs) for Phase I Investigational Drugs / Clinical Studies

Speaker

Instructor: Peggy Berry
Product ID: 705255

Location
  • Duration: 90 Min
This webinar will help attendees understand differences between GMP requirements for early and later stage clinical development. It will explore and discuss ways to develop and implement strategies for early GMPs for phase I clinical studies.
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Why Should You Attend:

Early clinical trials are conducted to establish initial safety of a drug. The studies are generally done 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 webinar 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.

Areas Covered in the Webinar:

  • 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
  • Vendor selection and management for outsourcing early manufacturing
  • Raw material selections and considerations

Who Will Benefit:

  • Directors
  • Managers/Supervisors
  • Regulatory Affairs Personnel
  • Manufacturing Staff
  • Quality Assurance and Clinical Operations Personnel
Instructor Profile:
Peggy Berry

Peggy Berry
Founder, Synergy Consulting LLC

Peggy J. Berry, MBA, RAC, is the president and 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). She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001).

She has also held regulatory affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book “Choosing the Right Regulatory Career” (RAPS, MD) and author of the 2011 book “Communication & Negotiation” (RAPS, MD).

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