NEW REGULATORY GUIDANCE SHARING THREAD Use this pinned post to share and discuss the latest regulatory guidance documents, updates, and announcements. How to contribute: Share links to new guidance with a brief summary Include the ...
This message was posted by a user wishing to remain anonymous Regulatory Science of CMC and Global Harmonization is so important for AAPS, across many other communities, such as CMC, PQ, Formulation, Global Heath... Let's post this on AAPS Community ...
Join us on Friday, August 28, from 12:00 to 1:00 PM ET for a CMC and Global Harmonization Discussion. Agenda 1. Welcome and community updates - 5 minutes 2. Overview: CMC regulatory science - 10 minutes What the discipline covers and which threads ...
Greetings! The tentative agenda for Friday's (August 28th @ 2pm EDT) Pharmaceutical Quality Meeting is as follows: Volunteer status updates Specification Team Updates Patient Centric Specifications webinar highlights AI/ML ...
Dear colleagues, USP has published a new Stimuli article, " Digital Twin-Enabling the Future of Development and Manufacturing of Pharmaceutical and Biopharmaceutical Products with Standardization and Consistency ." The article discusses ...
Come and join us to kick off our first webinar. It will be hosted by the Specifications Team of the PQ Community. Pharmaceutical specifications are pivotal in development, quality, and regulatory strategy. Once seen as fixed release/stability criteria, ...
Calling all regulatory professionals in the Philadelphia, New Jersey, and surrounding areas! If you're within driving distance of Ambler, PA, you are invited to join the Philadelphia and NY/NJ RAPS Chapters on Wednesday, August 19, beginning at 5:00 ...
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 ...
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 ...
A few updates on how the Regulatory Science Community is operating going forward. We are now meeting monthly on the AAPS Science 360 platform. Registration is required for each meeting. Science360 does not currently push a calendar invitation ...