Early clinical trial phases are conducted to establish initial safety of a drug. The drug trial 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 allowed early stage investigational products to be manufactured under less stringent GMP guidelines.
Why Should You Attend:
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 this 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
• Understand the differences permitted for phase I GMP compliance regulations
• Ensure that all of the right systems and procedures are in place
Who Will Benefit:
• Regulatory Affairs
• Quality Assurance and Clinical Operations
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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