Hi everyone,
Our May AAPS Regulatory Sciences Community meeting will be cancelled. In place of the meeting, please send written feedback to me (Jen Brown: [email protected]) on the following topics by 1 p.m. Friday, May 17th. I will then issue a summary of the feedback received.
Thank you,
Jen
Discussion Topics:
- Meeting date/time
- Starting with August meeting, move to noon at Mondays (12:05-12:55 p.m.); third Monday of each month – any objections?
- New regulatory guidances – Allison Radwick
- Update on involving the AAPS Scientific Advisory Committee (SAC) in these discussions?
- FDA draft guidance “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies”
- Update on response team – Raja
- Were representatives of the In Vitro Release and Dissolution Testing Community (Sanjaykumar Patel) and BE/BA Community added to the team?
- PharmSci360
- Please provide all sessions, panels, Hot Topics, Rapid Fires (submissions due June 14th) etc that you will be contributing to so that we can coordinate a full list of sessions where the Regulatory Sciences Community is contributing. Thank you!
- Separate session Patient Centric Specifications? Stan Altan and Sandra Suarez
- 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 to promote for RS)
- Webinar: “TiO2-Free Drug Products: Challenges During Drug Product Development” – Tahseen Mirza
- With the IV/IVC Community
- Status update? Speakers identified?