AGRE Forum

Hello All, I am seeking speakers for San Diego Regulatory Affairs Network’s (SDRAN) Drugs RAC Study Group and monthly programs. Additionally, I am seeking guest lecturers for a new International Regulations course for the MS in Regulatory Affairs program at San Diego State University (SDSU); I am trying to help provide my students with as much of a broad knowledge about international regulations as possible from as many subject matter experts that I can find. I am seeking the following speakers: SDRAN Drugs RAC Study Group The RAC Study Group is now Zoom pre-recorded sessions so you can record them whenever it is convenient for you. Here is a list of the speakers SDRAN is requesting: • US - Pharmacovigilance and Risk Management • EU - Pharmacovigilance • EU - Human Tissue Regulation • EU - Products Manufactured From Human Blood or Plasma • ROW - Health Technology Assessment (HTA) • ROW - Quality Systems and Inspectorate Process for Pharmaceuticals • ROW - High-Risk Products: Products Derived from Biotechnology • ROW - Regulatory Considerations for Cell-Based Medicinal Products • ROW - Botanical Drug Products and Traditional Medicine SDRAN Monthly Program We have a fair amount of flexibility in our schedule. We have openings in June, July, September, and November this year. The monthly programs can be in-person or via Zoom; it is whatever the speaker’s preference is. • EU Clinical Trial Regulation (CTR) and current events related to some upcoming 2023 due dates SDSU International Regulations Course I would appreciate any assistance you could provide in helping me to locate a few Guest Lecturers for this 2023 October – December course; I am trying to help provide my students with as much of a broad knowledge about international regulations as possible from as many subject matter experts that I can find. These lectures are pre-recorded on Zoom so the guest lecturer can record this lecture at their convenience as long as it is before October 2023. • Pharma EU Regulations • Biologic EU Regulations • Pharma Japan Regulations • Biologic Japan Regulations • Medical Device Japan Regulations • Pharma Brazil Regulations • Biologic Brazil Regulations • Medical Device Brazil Regulations • Pharma China Regulations • Biologic China Regulations • Medical Device China Regulations • Pharma Australia Regulations • Biologic Australia Regulations • Medical Device Australia Regulations • Pharma Canada Regulations • Biologic Canada Regulations • Medical Device Canada Regulations I apologize for the whirlwind of requests but I thought I would throw it out there and see if any of these topics are interesting to you. Please let me know if you or any of your colleagues might be interested in any of these speaking opportunities. I am happy to answer any questions or provide further details as needed. Thank you for your time and assistance, Kim Kim Walker, MS, RAC (US & EU), FRAPS President-Elect SDRAN Part-Time Regulatory/Quality/Clinical Instructor for San Diego State University & Roseman University Global Regulatory, Quality, & Clinical Consultant 714-273-9254 kimwalkerinstructor@gmail.com kimwalkerconsulting@gmail.com www.kimwalkerconsulting.com LinkedIn Profile: linkedin.com/in/kimwalkerconsulting

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