WEBINAR: Evolution of Specifications and Analytical Methods During Synthetic Peptide Drug Development
Thursday, March 14, 2019
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.
Michael Verlander, D. Phil
President - Proactive Quality Compliance, Inc.,
Member - USP Biologics Monographs 1 – Peptides & Insulins Expert Committee