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We are thrilled to announce an exciting webinar by Rajiv Nayer, PhD in collaboration with the #AAPS Preformulation and Formulation Design/Development community (PFDDC)

🔊 It's great to hear long-time AAPS members and leaders chat about the impact of the association. Tune in to the latest BioTalk Unzipped #podcast episode as Andy Vick discusses his career with hosts Chad Briscoe and Gregory Austin. He reflects how "AAPS is just kind of part of my DNA."

Hi everyone,

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

1. Welcome – Shraddha
2. Reminder re: meeting schedule
1. This is our last Friday meeting
2. Our next meeting is scheduled for Monday, August 19^th, 12:05-12:55 p.m.

                                                    i.     Jen is not available for this meeting – can someone else please take the minutes that day?

3. Meetings will continue on the 3^rd Monday of each month, 12:05-12:55 p.m. US Eastern time
2. 2024-2025 AAPS Regulatory Sciences leadership team
1. Please start thinking if you’re interested in serving
2. We have received interest in Vice Chair (yay!!)
3. Deadline for vice-chair applications is 31 July 2024
3. PharmSci360 – All
4. Webinar with PPDM Community on Career Development & Transitions – Vijay Tammara
1. 31 October 2024, 12:30-2:00 p.m.
5. TiO2 Webinar – Tahseen Mirza
1. Speaker identified?
2. Date/time?
3. Announcement to be shared
6. Other webinars that might be of interest to the RS Community
1. Topical and Transdermal Community: “Piercing a Way Through Regulatory Submission? Considerations for Microneedle Development and Application Submission”

                                                    i.     Speaker: Caroline Strasinger, PhD, Master Reviewer CDER, US FDA

                                                   ii.     26 July 2024, 12-1 p.m. US Eastern

8. New regulatory guidances
1. Allison will not be available this week
2. Please see attached for her updated list of guidances
3. Also: Allison and Mark Arnold will be working together to bring regulatory (US and global) guidances more into the AAPS channels. 
4. The Raw Materials OSD shared 3 US guidances to read and one from the EP. 
5. US Guidances

                                                    i.     Considerations for the Use of Human and Animal-Derived Materials in the Manufacture of Cellular and Gene Therapy and Tissue-Engineered Medical Products (mentioned by Lynn and Mo)

                                                   ii.     Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products (mentioned by Mo)

                                                  iii.     Platform Technology Designation Program for Drug Development

6. Also of interest:

                                                    i.     EMERGING EP 2.6.41 next gen testing and ICH Q5 RA2…adventitious viral agents, cell banks

                                                   ii.     https://www.ema.europa.eu/en/ich-q5ar2-guideline-viral-safety-evaluation-biotechnology-products-derived-cell-lines-human-or-animal-origin-scientific-guideline

                                                  iii.     https://www.edqm.eu/en/-/public-consultation-on-new-general-chapter-on-high-throughput-sequencing-for-the-detection-of-viral-extraneous-agents-in-pharmeuropa-36.2

9. Other?

Thank you,

   Jen