Hello, Our monthly meeting is Thursday, Jul 11th, 12 PM PT/3PM ET. We hope you can join us!
Agenda:
- First time attendees/new member introductions
2. Standing: Items of interest from other Communities to AAPS
- KENX Lab University - Jun 4-6 (Philadelphia): Lab management, Stability, Analytical Quality track - Kim/All
- ICH Guidance Updates: ICH M4Q, ICH Q1 - EFPIA/Bio/Pharma commenting through May - Kayla/Lori/All
ICH Q1 – turn in comments to Bio on initial draft, mid-May
Link to the M4Q(R2) Work Plan - https://database.ich.org/sites/default/files/ICH_M4Q%28R2%29_EWG_WorkPlan_2024_0311.pdf
Targeting Nov 2024 for Step 2 endorsement (public consultation)
3. Member Engagement: All
- PDA standard – LCM for analytical procedure - draft document is out for commenting; Nanda shared PDF with Stability community. Kim provided link for commenting to those interested
- Webinar – IABS on reagents availability – July 2nd - https://events.iabs.org/hsi-webinar-critical-reagents-2024
- Encourage All to continue to engage over email and community page (eg MFI for sub vis particulates, CCIT methods etc in previous months)
4. Reminder: Topics for 2024 PharmSci 360 Submission - Kim & All
o 2 of Kim’s proposals accepted
o Career Track: How to Negotiate Contracts Like A Pro
- Technical Track: Data Control and Data Security Management in Pharmaceutical Quality Assurance
5. Increasing Member engagement: webinar and/or virtual discussion once per Quarter
Use one Stability monthly meeting slot for webinar or virtual discussion.
a. Virtual Panel Discussion (2Q): at 9th May Stability meeting: In-Use Stability Topic - completed
b. Discussion Topic/Webinar in 3Q/4Q:
- Shipping - USP chapter and recent articles - Discussion topic at July meeting– Nanda/ Camilla
- which studies are necessary vs good to have- Nanda interest in webinar/Kim suggest speaker
§ controlling the operations- temperature of the trucks or the monitors instead of qualify every single shipping route?
§ perform risk analysis: shipping trucks break down and justify the study they perform.
§ Any recent poll about shipping best practices? - align expectations between companies
- Suggestions for future topics/presenters – All
o IQ consortium recent papers on In-Use stability; discussion of ICH Q14 ; Mini-case study from Jan WCBP, or similar to KENX San Diego
6. Sterile Products Community (if SPC members can join, Hitesh, Haresh, Yogita)
- Discussion on further collaboration : co-sponsor a presentation/ discussion with broader invitations
- Last year, photostability; culminated in a webinar that was broadly available with over 200 attendees
- Focus on "Stability aspects of ADCs" - could be a series 2-3 webinars if needed. Timing:In early to mid Sep, based on the speaker availability
- Speaker planned: Prof. Schöneich from University of Kansas; Photostability of new modalities like ADC and gene therapy; Haresh will connect with AAPS webinar team
7. Joint Quarterly Stability-Stats Community
· 2Q (June 20): Reference standard (RS) and use of long-term stability data to support requalification of RS - Completed – Thanks Helen Strickland and Stephanie Ferrari!
Continue the RS topic/discussion in 4Q joint meeting? - Trending analysis ; expiry extensions
· 3Q: Comparability Part II - Dan W. for Stability; Stats - Aili Cheng
· 1Q24: Use of means vs individual values to evaluate stability data - Kayla Woodlief and Ben Ahlstrom – Completed - thanks!
8. Open discussion
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Microsoft Teams meeting
Join on your computer, mobile app or room device Click here to join the meeting<https://teams.microsoft.com/l/meetup-join/19%3ameeting_NWUxZjY4ZGQtOGFlYy00ZmQ3LWFlZTctZDNjMzM3MzM4Yjdl%40thread.v2/0?context=%7b%22Tid%22%3a%221ad4c8f9-44ec-4870-9515-b42d64d49a4e%22%2c%22Oid%22%3a%220e166dbd-aa42-4622-9bb8-46a8a0178822%22%7d> Meeting ID: 282 196 477 610 Passcode: 869yNv