December (2006) 11th and 12th: - The WHCC organized seminar presentations by Darin J. Weber, PhD, Senior Consultant with the Biologics Consulting Group, Inc.:
- “Addressing Regulatory Concerns While Translating from Research to Clinical Applications”
This presentation addressed the importance of good documentation practices (GDP) with reference to internal and external scrutiny on the elements of good laboratory practices (GLP) to ensure data integrity. View Presentation.
- “The FDA and Quality Manufacturing of Biological Products”
This presentation provided an overview of the FDA, and the IND process, with special emphasis on quality manufacturing (GTP & GMP) and product development for cell-based therapies. View Presentation.
Dr. Weber also met with UM Principal Investigators and staff from the Centers of Excellence for further discussion pertaining to regulatory concerns. |
