Regulatory Sciences Community

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Leadership

Chair: Shraddha Thakkar | Vice Chair: Amit Tiwari | Past Chair: Raja Velagapudi | Secretary: Jennifer Brown | Learning Opportunities Managers: Neeraj Kaushal, Allison Radwick | Member Engagement Managers: Khushboo Jani, HariPriya Kandagatla, Sruthi Sarvepalli, Jason Sriwijaya


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Latest Discussion Posts

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Announcements

  • Agenda for 19 July 2024 Meeting

    Hi everyone,

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

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

      1. Meetings will continue on the 3rd Monday of each month, 12:05-12:55 p.m. US Eastern time
    1. 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
    2. PharmSci360 – All
    3. Webinar with PPDM Community on Career Development & Transitions – Vijay Tammara
      1. 31 October 2024, 12:30-2:00 p.m.
    4. TiO2 Webinar – Tahseen Mirza
      1. Speaker identified?
      2. Date/time?
      3. Announcement to be shared
    5. 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

    1. 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

      1. 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

    1. Other?

    Thank you,

       Jen

    More
  • Agenda for 21 June 2024 meeting

    Below please find the agenda for tomorrow’s AAPS Regulatory Sciences meeting (June 21st, 12:05-12:55 p.m.). 

    1. Welcome – Shraddha
    2. Introductions, new members (if any) – All
    3. Meeting date/time
      1. Starting with August meeting, move to noon at Mondays (12:05-12:55 p.m.), third Monday of each month – any objections?
    4. New regulatory guidances – Allison Radwick
      1. Update on involving the AAPS Scientific Advisory Committee (SAC) in these discussions?
    5. PharmSci360 – All
      1. What sessions have been accepted?
    6. Separate session on Patient Centric Specifications - Stan Altan and Sandra Suarez
    7. Webinar with the PPDM Community on Career Development & Transitions
      1. Speakers: Vijay Tammara and Islam Younis
      2. Presentations and panel discussion
      3. Date: Tuesday, 15 October 2024
    8. Webinar on TiO2 – Tahseen Mirza
      1. With the IV/IVC Community
      2. Tahseen to provide an announcement that can be shared with the RS Community
    9. Other?
    More
  • Written summary in lieu of May meeting

    Below please find a summary of topics gathered in lieu of the AAPS Regulatory Sciences May 2024 meeting.

    • PharmSci360
      • Kim submitted eight topics (four on data management and four on QbD) and only one (#2 in the list below) was tentatively accepted (remaining suggestions were rejected):
        1. Data Security Strategies for Protecting Confidential Information in Pharmaceutical Industry
        2. Data Control and Data Security Management in Pharmaceutical Quality Assurance
        3. Digital Tools, Techniques, and Regulatory Considerations in Data Assessment
        4. How Data Integrity Impacts the Analysis and Decision Making
        5. Navigating Pharmaceutical Development with Quality by Design (QbD) Principles
        6. Strategic Implementation of QbD Approaches in Drug Development
        7. Elevating Pharmaceutical Development: Advanced Tools and Techniques for QbD Implementation
        8. Ensuring Compliance with QbD Principles Across Global Regulatory Frameworks
    • FDA draft guidance “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies”
      • Raja met with the review team to discuss the draft guidance and comments
        • Main issue: redundancy with other guidances that already address data integrity
        • Unclear what the bioavailability study means to FDA
        • Many other smaller comments as well
      • Boris will take all comments and communicate them to FDA from AAPS
    More
  • Cancellation of the May meeting of the AAPS Regulatory Sciences Community

    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:

    1. Meeting date/time
      1. Starting with August meeting, move to noon at Mondays (12:05-12:55 p.m.); third Monday of each month – any objections?
    2. New regulatory guidances – Allison Radwick
      1. Update on involving the AAPS Scientific Advisory Committee (SAC) in these discussions?
    3. FDA draft guidance “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies”
      1. Update on response team – Raja
      2. Were representatives of the In Vitro Release and Dissolution Testing Community (Sanjaykumar Patel) and BE/BA Community added to the team?
    4. PharmSci360
      1. 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!
    5. Separate session Patient Centric Specifications? Stan Altan and Sandra Suarez
    6. Excipients Community May 23rd Open Scientific Discussion on the Analysis of Nitrosamines in Cellulose Ether - Allison Radwick
      1. Excipients Community to moderate
      2. Plans for co-promotion (Jen and Khushboo to promote for RS)
    7. Webinar: “TiO2-Free Drug Products: Challenges During Drug Product Development” – Tahseen Mirza
      1. With the IV/IVC Community
      2. Status update? Speakers identified?
    More

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