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Career Paths & Volunteer Opportunities in Global Health Join us for a discussion on CMC career opportunities in global health, moderated by Lisa Crandall, Principal CMC Consultant and founder of Strategic CMC Insights, with over 25 years of experience ...

Dear AAPS Group Members, Thank you for initiating this important discussion on BU testing. I appreciate the opportunity to engage with experts and stakeholders on this topic and learn from the collective experience within the community. I would ...

Thanks for starting a thread on the BU topic. It's just great to have the BU thoughts of ISPE hidden behind a membership requirement. I have done BU/CU on many OSD products and have a few opinions and would really like to collaborate with an industry ...

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 for industry on scale-up and postapproval changes (SUPAC) for specific dosage forms. To Submit ...

Hello AAPS Friends, I am posting this as a thread to facilitate discussion regarding modern industrial blend uniformity testing practices. From what I have been able to gather, current guidance has been established via the International Society for ...

Hello community members, A quick reminder about tomorrow's webinar on Digital Twins . This is a great opportunity to learn what a virtual replica is and how digital twins are being applied in biopharmaceutical and pharmaceutical Industry. If ...

Hello everyone. If available and interested, please attend Pharmaceutical Quality's monthly meeting this Friday, June 26th at 2pm EDT. See the link below for access. The agenda is tentatively as follows: Regulatory Response Updates Volunteer Status ...

Starting this Friday (June 26), Regulatory Science Community meetings move to AAPS Science 360. You'll sign in and register each month, and we'll post the topic and speaker as a reminder. We meet every month on the 4th Friday, 12–1 p.m. ET. This month, ...

https://www.linkedin.com/posts/andregwolff_its-a-pleasure-working-with-high-profile-share-7469852648062648320-PmHm/?utm_source=share&utm_medium=member_desktop&rcm=ACoAAAEu3D0BL_RC4LQe61tosip5m-bxAHn0DX8 Yihong Qiu

USP has published four draft analytical method standards for biologic products and opened them for early stakeholder input - ahead of the formal compendial process . This pre-official window is a meaningful opportunity to help shape these methods before ...