WEBINAR: Evolution of Specifications and Analytical Methods During Synthetic Peptide Drug Development
Thursday, March 14, 2019
12:00PM Eastern
The webinar will focus on challenges related to measurement of process and product related impurities with a case study to illustrate the principles.
Development of specifications within a product life cycle framework will be included with considerations that are helpful at each step. Regulatory and compendial guidance will be identified so that participants are aware of relevant references. A significant portion of the webinar will focus on challenges related to measurement of process and product related impurities with a helpful case study to illustrate the principles.
The webinar will be led by Dr. Michael Verlander, a well-known expert in this field, who has successfully brought many synthetic peptides through the development and approval process.
Speaker
Michael Verlander, D. Phil
President - Proactive Quality Compliance, Inc.,
Member - USP Biologics Monographs 1 – Peptides & Insulins Expert Committee