Here is the agenda for this week’s (Friday, 17 March 2023) AAPS Regulatory Science Community meeting:
- Welcome – Raja Velagapudi
- Introductions, new members – All
- Potential PharmSci360 session proposals? – All (main Focus)
- Please think of 1 or 2 topics will fit into Symposium or Hot Topics. If collaboration with other communities please identify your collaborators.
- MSE Community - Continuous manufacturing and AI & Automation (AI regulation ??)
- PPDM Community – MIDD OPTIMUS/ LAI absorption, IVIVC ?/ In-Silico methods/regulatory acceptance for Tox/preclinical (hot topic 2- 3 speakers)
- Webinars (Neeraj –Contact):
- CAR-T webinar with Global Health Community – Sumana Penumetcha, Sudip Das, Neeraj Kaushal, Deepa Deshpande
- 09 May 2023, 12:30-2:00 p.m.; Free, registration open
- Training 01 May 2023, 11:00-11:30 a.m.
- Webinar and Workshop on Data Integrity & Compliance – Tahseen Mirza, Khushboo Jani, Neeraj Kaushal
- FDA speakers? – Tahseen Mirza, Sam Raney, Priyanka Ghosh
- Webinar on Ongoing Global Regulatory Harmonization Efforts – Sam Raney, Sanjay Sehgal, Priyanka Ghosh
- Other potential webinars? TiO2, nitrosamines, propellants, others?
- Joint webinar with PDPD (Pharmaceutical Discovery and Product Development) Community on IND preparation? – Haian Zheng
- RS 101 Course (status) – Kim Huynh-Ba
- If time allows: Potential paper updates – Kim, Sudip
- Other?
- Next meeting – 21 April 2023
Please let me know if you do not have the meeting invite on your calendar (12:05-12:55 p.m. Eastern) and I will add you to the invite list.
Hope to “see” you there!
Thank you,
Jen