Dear All,
A reminder about our next meeting this Thursday, Oct 10th, 12 pm PT / 3PM ET. Hope you can join us!
Agenda:
- First time attendees/new member introductions
- Standing: Items of interest from other Communities to AAPS
- ICH Guidance Updates: ICH M4Q, ICH Q1 - EFPIA/Bio/Pharma commenting through May - Kayla/Lori/All
ICH Q1 - Lori – all comments turned in from different groups that are member of EWG – Bio, pharma etc - public draft expected year end
ICH went to EWG – group meeting together; not much info expected for a while; comments from constituent groups being review; public comment draft by end of year
M4Q(R2) Work Plan Link - 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)
CASSS CMC Strategy forum; Ken share update at future meeting – Agenda
3. Member Engagement: All
- Summary of this year’s Stability Community Activities – Vinaya & team
- Encourage All to continue to engage over email and community page (eg MFI for sub vis particulates, CCIT methods etc in previous months, Stability software query on the community)
- Question regarding Appearance test result.
- Appearance test is performed for parenteral product release and stability samples. When a test result 'product related particulates' is obtained, with acceptance criteria of '..... Essentially free of visible particulates.', do you consider the test result as a suspect OOS result that needs initiation of lab investigation?
4. Reminder: 2024 PharmSci 360
o Stability Community Update at PharmSci 360 October
Tue 22Oct – 5-6 PM – Room 151 ABCG – Stability Community meeting
· 2 of Kim’s proposals accepted
Career Track: How to Negotiate Contracts Like A Pro
o Technical Track: Data Control and Data Security Management in Pharmaceutical Quality Assurance
o Working on another topic for AI and career track - full day focus;
Artificial Intelligence Communication: the do's and don'ts for using AI language tools in your technical job at every level
|
AI in scientific and technical writing - a conversation with David Hauss
|
Generative AI in the Wild: Navigating your organization’s AI adventure!
|
AI in quality and regulatory - the future is already here
|
5. Increasing Member engagement: webinar and/or virtual discussion once per Quarter
Virtual Panel Discussion (2Q): at 9th May Stability meeting: In-Use Stability Topic - completed
Discussion Topic/Webinar in 3Q/4Q:
· Shipping - Survey responses and reflections –Camilla/Nanda
o Stability and Shipping Practices
· 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)
- 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
- Prof. Schöneich from University of Kansas; Photostability of Therapeutic Protein Modalities: Products, Mechanisms, and Mitigation
- Timing: 19Nov – 12:30 -2 PM ET ; part 2 in 1Q25
1Q2025 could have another related topic - depends on SPC interest
7. Joint Quarterly Stability-Stats Community
· 4Q - Continue the RS topic/discussion in 4Q joint meeting? - Trending analysis ; expiry extensions – Stephanie F. to confirm with Helen
- 3Q: Comparability Part II - Sep 12th Completed - Thanks! Dan W. for Stability; Stats - Aili Cheng
- 2Q (June 20): Reference standard (RS) and use of long-term stability data to support requalification of RS - Completed – Thanks Helen Strickland and Stephanie
· 1Q24: Use of means vs individual values to evaluate stability data - Kayla Woodlief and Ben Ahlstrom – Completed - thanks!
8. Open discussion
Meeting ID: 282 196 477 610
Passcode: 869yNv