RAPS San Francisco Chapter

RAPS San Francisco Chapter is proud to have three award recipients! Chapter Chair Yoshiko Stowell, PhD, RAC, PMP received the Community Leadership Award ✨ Surina Gulati and Dinesh Puppala, MS RAC received the Rising Star Awards 🌟

Please join the workshop on global submissions organized by Regulatory Affairs Professionals Society (RAPS) San Francisco Chapter and PBSS International San Francisco Bay. Great lineup of speakers: - Two FDA speakers: Jay Fajiculay, Pharm.D. and Kristina N. Luong, PharmD, BCPS - EMA speaker Efstratia Vatzaki - Yoshiko Stowell, PhD, RAC, PMP RAPS San Francisco Chapter Chair, VP of Regulatory Affairs at Kenai Therapeutics - Huong Huynh Reagan, Director of Regulatory Science Critical Path Institute (C-Path) - Xiling Song, VP Global Head of Regulatory CMC BeiGene - Yoshimasa Shimoto, Partner Consulting and Navigation Unit CMIC Group - Bargavi Elangovan, Associate Director, Regulatory Information Management Biogen - William S., VP Regulatory Toxicology and Clinical Pharmacology Premier Consulting - Brandon Rice, Chief Product Officer Weave Regulatory Affairs Professionals Society (RAPS) members - use  20% discount code: 120241010RAPS Take advantages of the Academic or Out of Pocket rate of $45 Register today at https://lnkd.in/gdcghhhV

Please join the RAPS San Francisco Chapter on Tuesday, October 22nd from 5:30-7:30pm for an in-person event on the topic of IVD Regulatory Overview and Updates. We are welcoming Balazs Bozsik and Daniel Fisher from SGS as our speakers. Additional thanks to Fogarty Innovation for sponsoring the event and hosting at their location in Mountain View. Hope to see you all there!

🔔 Reminder: Join us at the upcoming Regulatory Affairs Professionals Society (RAPS)/RAPS San Francisco Chapter In-Person Event: The Pulse of MedTech 🚀 📅 Date: Thursday, October 10th, 2024 🕒 Time: 5:00-8:30 PST 🔗 Register Now at the Regulatory Affairs Professionals Society (RAPS) website: https://lnkd.in/gxyREqQx 💵 Cost: Student $15 | Member $25 | Nonmember $45 ✨✨Join us for this dynamic session and secure your spot today! ✨✨ 👇See below for more details 🔄If you found this post interesting, consider liking, sharing with your network and/or reposting. #MedTech #RAPS #RegulatoryAffairs #Networking #ProfessionalDevelopment

The Highlights: RAPS Convergence 2024 I consider myself very fortunate to be able to attend the RAPS convergence last week in Long Beach, California. The biggest highlight for me was the opportunity to share the stage with regulatory experts Yoshiko Stowell, David Pudwell, and Christelle Bouygues (EMA speaker) to present on a very important topic of Precision Medicine using Companion Diagnostics, AI/ML modeling, and Digital Health Technology. Precision Medicine is the reality of today and companion diagnostic, AI/ML, and Digital Health Technologies play a crucial role in its application, however, the future of Precision Medicine for the patient care depends largely on the development of appropriate regulations and the establishment of legal requirements to ensure timely availability of these therapies to the needy patients and to secure their safety and privacy. In addition, the convergence was a great opportunity to learn about regulatory topics such as the application of artificial intelligence in regulatory affairs, challenges in developing treatments for unmet medical needs, and new regulations and their applications in overall drug and device development. Some of the most interesting sessions were the Health Authority Forum, and Conversations that Matter, which allowed us to listen directly from the experts from the FDA and the EMA. This year's Convergence was attended by more than 2000 regulatory professionals from 37 countries and 40 states within the US. It was a great opportunity to meet and connect with regulatory professionals and regulators from all over the world, US, EU, Canada, Brazil, Japan, China, India, Taiwan, Saudi Arabia, Australia, Argentina, etc. The event was packed with over 160 sessions and the opportunity to hear from over 320 expert speakers around the globe. Proudest moment for me to see the achievements of our RAPS SF Bay Area Chapter and the our Chapter Chair, Yoshiko Stowell, PhD, RAC, PMP receiving the Community Leadership Award. Our chapter had a great representation at the Convergence this year, looking forward to continue to volunteer and collaborate with our friends in regulatory. It’s been the most rewarding experience of regulatory journey. And, last. But not the least, it was wonderful to meet the members of our specialty club, Regulatory Affairs Toastmasters (RAT) in person :) Thanks to the entire RAPS community for organizing such an insightful event. Looking forward to the next one!!! RAPS San Francisco Chapter Regulatory Affairs Professionals Society (RAPS) Regulatory Affairs Toastmasters (RAT)

RAPS San Francisco Chapter and PBSS GROUP San Francisco are excited to collaborate on a full day workshop on Regulatory Global Submission: Strategies and Best Practices for FDA, EMA, and PMDA. Two FDA speakers (Jay Fajiculay, Pharm.D. and Kristina N. Luong, PharmD, BCPS) and one EMA speaker (Efstratia Vatzaki) will join remotely with an exclusive panel discussion. Other topics are Yoshiko Stowell, PhD, RAC, PMP: "Overview of Regulatory Submissions 101, NDA, MAA, and J-NDA" Huong Huynh Reagan: "Harnessing the Power of Patient Data: Impact of Public-Private Partnerships in Regulatory Science and Drug Development" Xiling Song: "Strategies and Best Practices to Accelerate Right First-Time CMC Dossier Readiness for Global Regulatory Submissions" William S. "Streamlining Repurposed Drug Development: 505(b)(2) NDA Strategies" Yoshimasa Shimoto "Changes in Japan Regulatory Environment and Implication for Drug Development" There would be another panel discussion to hear from the afternoon speakers. Don't miss out the networking opportunities and meet with the major Sponsor, BioIVT and visit Meadowhawk Biolabs, Inc.'s vendor show. Register Today at https://lnkd.in/gdcghhhV #regulatory #RAPS #regulatorysubmissions Regulatory Affairs Professionals Society (RAPS)

⏰Reminder: Join us at the upcoming Regulatory Affairs Professionals Society (RAPS)/RAPS San Francisco Chapter In-Person Event: The Pulse of MedTech 🔗 Register Now on the RAPS website (if you have registered via LinkedIn you will not be officially registered for the event): https://lnkd.in/gxyREqQx

Great plenary session and RAPS San Francisco Chapter Informal Networking Please come see Regulatory Affairs Professionals Society (RAPS) Chapters and Local Networking Groups (LNGs) Greet and Meet tomorrow (9/18) at 3:30-4:30pm at Booth 349!

Attending #RAPSConvergence 2024? Regulatory Affairs Professionals Society (RAPS) San Francisco Chapter is having an Informal Networking Event at Hyatt Regency connected to the convention center. No registration is needed. No need to register for the convergence if you happen to be in the area. Please feel free to stop by with friends to meet RAPS San Francisco Chapter!

Regulatory Affairs Professionals Society (RAPS) San Francisco Chapter is excited to welcome one EMA speaker and two FDA speakers who will join the RAPS San Francisco Chapter/PBSS International Workshop Regulatory Global Submission virtually. Make sure to attend it on October 10. Register today at https://lnkd.in/gdcghhhV Doesn't your work support the registration fee or are you between the jobs or students? Please take advantage of the Academic/Students/Postdocs/Out-of-Pocket option of $45.