SDRAN/RAPS RAC Drug and Device Exam Practice Questions Workshop by Admin SDRAN | | SDRAN Events Saturday, 18 October 2025 SDRAN/RAPS RAC Drug and Device Exam Practice Questions Workshop Drug RAC Panelists Tyler C. Vandivort, PhD, RAC, DABT Associate Director, Regulatory Affairs Lead UCB Biopharma Ajit Simh, MS Founder/President, Shiba Associates SDSU Instructor Device RAC Panelists Natalie Kennel President NJK & Associates Kim Walker, MS, RAC (US & EU), FRAPS Faculty Director, Graduate Advisor, & Instructor SDSU Center for Regulatory Science Global Regulatory, Quality, & Clinical Affairs Consultant DATE: Saturday, 18 October 2025 TIME:       RAC Drug Exam Practice Questions Session 08:00 AM -12:00 PM Pacific Time  Networking Lunch 12:00 – 1:00 PM Pacific Time RAC Device Exam Practice Questions Session 1:00 – 5:00 PM Pacific Time LOCATION: MiraCosta College-Oceanside  Aztlan A Conference Room (OC3450) | Building 3400 1 Barnard Drive, Oceanside, CA 92056 This event is also being offered virtually. The zoom link will be shared with you via email 1-2 days before the event. Click here to register for this event. Workshop Overview: Prepare with confidence for your RAC Drug and Device exams! This workshop offers a comprehensive review of example RAC exam questions led by seasoned experts who have passed the RAC exams and designed official practice materials in recent years. What to Expect: Proven test-taking strategies and study tips Insights from contributors to RAC practice exams Live review of practice exam questions with experienced professionals Q&A Panel Discussion Networking with subject matter experts and regulatory affairs colleagues Whether you’re just starting your RAC prep or looking to refine your knowledge, this workshop is designed to give you a competitive edge. This event is held at MiraCosta College-San Elijo campus at Cardiff, California.  In-person attendance is encouraged for those in the Southern California area.  Zoom attendance is available for those unable to attend in-person. Event Agenda: Time Topic Presenter/Panelist 8:00 – 8:30 am Check-In Continental Breakfast/Networking 8:30 – 8:45 am SDRAN Overview Laura Guy, SDRAN President RAPS Overview TBD Drug RAC Study Group Overview Jing Li, SDRAN VP of Education 8:45 – 10:00 am Drug RAC Practice Exam Questions Review (Providing rationales for correct & incorrect answers) Tyler Vandivort & Ajit Simh 10:00 – 10:15 am  Break & Networking 10:15 – 11:15 am  Drug RAC Practice Exam Questions Review Tyler Vandivort & Ajit Simh 11:15 am – Noon Drug Panel Q&A (For attendees to ask additional RAC Drug Exam related questions) Tyler Vandivort & Ajit Simh 12:00 – 1:00 pm Lunch & Networking 1:00 – 1:30 pm SDRAN Overview Laura Guy, SDRAN President RAPS Overview TBD Device RAC Study Group Overview Jing Li, SDRAN VP of Education 1:30 – 2:45 pm Device RAC Practice Exam Questions Review (Providing rationales for correct & incorrect answers) Natalie Kennel & Kim Walker 2:45 – 3:00 pm  Break & Networking 3:00 – 4:00 pm  Device RAC Practice Exam Questions Review Natalie Kennel & Kim Walker 4:00 – 5:00 pm Device Panel Q&A (For attendees to ask additional RAC Device Exam related questions) Natalie Kennel & Kim Walker Click here to register for this event. Registration Information: Member  (SDRAN, OCRA-DG, RAPS) Whole day Drug 1/2 day Device 1/2 day Regular $100 $75 $75 Student, Unemployed, Government $75 $50 $50 Non-member Whole day Drug 1/2 day Device 1/2 day Regular $150 $100 $100 Student, Unemployed, Government $100 $75 $75

How to Prepare for a Regulatory Inspection: Planning for Success Program Speaker: Ajit Simh  SVP Global Drug Compliance at Arcturus Therapeutics Inc. Adjunct professor at SDSU and UCSD   Event Agenda: DATE: Monday, September 15 2025 TIME: 6:00 – 6:15 PM Welcome and Announcements   6:15 – 6:35 PM How to Prepare for a Regulatory Inspection 6:35 – 6:55 PM Import Process Overview  6:55 – 7:15 PM Q&A 7:15 – 7:30 PM Wrap Up LOCATION: This event is being offered virtually.   The zoom link will be shared with you 1-2 days before the event. Click here to register for this event to attend VIRTUALLY. Presentation Topic Title: How to Prepare for a Regulatory Inspection: Planning for Success This presentation will provide a practical guide to understanding the purpose of Pre-Approval Inspections (PAIs) and the strategies necessary to ensure a successful outcome. Through real-world examples, Ajit will highlight common challenges and effective solutions for preparing for both GMP and Clinical (BIMO) inspections, with a focus on first-time PAIs. Speaker Biographies: Ajit Simh brings over 30 years of experience in the biopharmaceutical industry, specializing in active pharmaceutical ingredients (APIs), biologics (recombinant proteins and vaccines), oral solid dosage forms, ointments, parenterals, and medical devices. He has led and hosted numerous GMP and BIMO Pre-Approval Inspection (PAI) preparedness activities in the U.S. and internationally. Most recently, Ajit has collaborated with regulatory agencies including the EMA, HPRA, and PMDA to support successful inspections. In addition to his industry work, Ajit has been actively engaged in academia since the mid-1990s. He has served as an adjunct faculty member in the graduate program at San Diego State University and as an instructor at the University of California, San Diego, where he has also contributed to advisory boards. Registration Information: Register for the event here Contact  [email protected]  Pricing – Online – Registration (ends Sunday, September 14, 2025) Registrant Type virtual event price  Member $10.00 Lifetime $10.00 Non-Member $20.00 Cancellation Policy There will be no refunds for cancellations.