Hi everyone,
Below please find the agenda for tomorrow’s AAPS Regulatory Sciences meeting (April 19th, 12:05-12:55 p.m.).
- Welcome – Amit
- Introductions, new members (if any) – All
- FDA draft guidance "Data Integrity for In Vivo Bioavailability and Bioequivalence Studies” - Raja
- response team to consider the recently posted draft guidance – Raja to sit on this team and represent the Regulatory Sciences Community
- Boris Gorovits, of the AAPS Scientific Advisory Committee (SAC) to chair the response team
- Plans for round-table discussions on this draft guidance – Amit and Shraddha
i. Cross-community lunchtime webinar
- New regulatory guidances – Allison Radwick
- PharmSci360 – Updates on proposals submitted for symposia and/or hot topics (due April 7th)
- Patient Centric Specification – Stan, Kim, Shraddha, Amit
- QbD Principles, Approaches and Compliance – Sandra Suarez-Sharp, Kim HuynhBa, Stan Altan, Vijay Tammara
- Data Integrity and bioanalysis – Tahseen Mirza
- Artificial Intelligence and Quality – Raja and Amit
- Complex Excipients – Allison Radwick
- Preclinical Statistics – Stan Altan
- Pre-Clinical, Clinical Translational Tracks – Joan, Shraddha, Raja, Amit, Vijay
- Career Development – Kim, Shraddha
- Excipients Community May 23rd Open Scientific Discussion on the Analysis of Nitrosamines in Cellulose Ether - Allison Radwick
- Excipients Community to moderate
- Plans for co-promotion (Jen and Khushboo)
- Webinar on TiO2 – Tahseen Mirza
- With the IV/IVC Community
- Tahseen to provide an announcement that can be shared with the RS Community
- Other?
Thank you,
Jen