Announcements

Hi everyone,

Below please find the agenda for tomorrow’s AAPS Regulatory Sciences meeting (April 19^th, 12:05-12:55 p.m.).

1. Welcome – Amit
2. Introductions, new members (if any) – All
3. FDA draft guidance "Data Integrity for In Vivo Bioavailability and Bioequivalence Studies” - Raja
1. response team to consider the recently posted draft guidance – Raja to sit on this team and represent the Regulatory Sciences Community
2. Boris Gorovits, of the AAPS Scientific Advisory Committee (SAC) to chair the response team
3. Plans for round-table discussions on this draft guidance – Amit and Shraddha

                                                               i.      Cross-community lunchtime webinar

4. New regulatory guidances – Allison Radwick
5. PharmSci360 – Updates on proposals submitted for symposia and/or hot topics (due April 7^th)
1. Patient Centric Specification – Stan, Kim, Shraddha, Amit
2. QbD Principles, Approaches and Compliance – Sandra Suarez-Sharp, Kim HuynhBa, Stan Altan, Vijay Tammara
3. Data Integrity and bioanalysis – Tahseen Mirza
4. Artificial Intelligence and Quality – Raja and Amit
5. Complex Excipients – Allison Radwick
6. Preclinical Statistics – Stan Altan
7. Pre-Clinical, Clinical Translational Tracks – Joan, Shraddha, Raja, Amit, Vijay
8. Career Development – Kim, Shraddha
6. Excipients Community May 23rd Open Scientific Discussion on the Analysis of Nitrosamines in Cellulose Ether - Allison Radwick
1. Excipients Community to moderate
2. Plans for co-promotion (Jen and Khushboo)
7. Webinar on TiO2 – Tahseen Mirza
1. With the IV/IVC Community
2. Tahseen to provide an announcement that can be shared with the RS Community
8. Other?

Thank you,

   Jen