Announcements

  • Agenda for 15 March 2024 Regulatory Sciences Community meeting

    By: Jennifer Brown Jennifer Brown , one month ago

    Hi everyone,

    Below please find the agenda for our AAPS Regulatory Sciences meeting tomorrow (Friday, 15 March 2024).

    1. Welcome – Amit
    2. Introductions, new members (if any) – All
    3. Excipients Community May 23rd OSD on the Analysis of Nitrosamines in Cellulose Ether - Allison Radwick
      1. An IFF expert will lead the discussion
      2. Impurities Community may partner
      3. Does the Reg Sciences community want to partner?
    4. Update on Patient-Centric Specification discussions – Stan, Kim, Shraddha, Amit
      1. Session proposal for PharmSci360? Deadline April 8th
      2. Article?
    1. PharmSci360 – Status of session proposals - All
      1. Data Integrity – Tahseen Mirza
      2. Complex Excipients – Allison Radwick
      3. Other potential topics – identify list of topics and point-person for each
          1. QbD principles, approaches, and compliance
          2. Preclinical Statistics
          3. QbD and Compliance – Vijay and Stan
          4. Artificial intelligence and Quality
          5. Pre-clinical, Clinical translational tracks
          6. Kim and Shraddha represent career development (Career Transition in Industry: Why, When and How? (aaps.org)), so topic need not be a scientific one
    1. New regulatory guidances – Allison Radwick
    2. Webinars – potential topics and leaders
    3. Other?

     

    Thank you,

        Jen