Hi David, hope everthing is fine. I would like to know if you could include me in the excipients community. Best regards, Veronica ------------------------------ Veronica Blanco Technology Specialist Croda Plainsboro NJ [email protected] ...
Salutations! Please see the attached meeting minutes and slides from our July Pharmaceutical Quality meeting. We have quite a few exciting events planned in the upcoming months, including some great webinars based on patient centered specifications ...
The Excipient & Supply Chain Team within the Pharmaceutical Quality Community will be hosting a webinar on September 15, 2026 on: " Establishing Effective Stability Programs for Pharmaceutical Excipients" . We welcome anyone from other communities ...
New guidance from the FDA for gene and cell therapy CMC. I thought you may find it helpful. Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application; Guidance ...
Hello everyone. The tentative agenda for tomorrow's (July 24th @ 2pm EDT) Pharmaceutical Quality Meeting is as follows: Volunteer status updates Specification Team Updates AI/ML Team Updates Excipient & Supply chain Updates ...
Dear Members VERY IMPORTANT ( The LAST DATE OF SUBMITTING COMMENTS IS JULY 13, 2026.) Please note FDA by a Notice on 03/03/2026 announcing the opening of a public docket to solicit information and comments on the Agency's series of guidances ...
Dear AAPS Pharmaceutical Quality team, AAPS is considering a response to the FDA revised draft: Demonstrating Substantial Evidence of Effectiveness (FDA-2019-D-4964). Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological ...
Hi Kim, I think that Pricilla Zawislak would be the perfect person to do this presentation/webinar since she was on the revision team for this IPEC Stability guide and she has done a number of webinars on excipient stability in the past for IPEC ...
I was thinking the same thing last weekend, so I totally agreed. Who would be the best person to organize this? Who would be the best speaker for this webinar? Can you address it? Bests, Kim
Hi Kim, As you know, I am interested in participating on this team. I will be contacting Catherine at USP this week about what we discussed. I think there are a number of excipient topics that we might want to discuss. One possibility might ...