Greater San Diego Chapter: Where REMS Meets Reality - Psychedelics, Patients, and Clinical Trials

Greater San Diego Chapter: Where REMS Meets Reality - Psychedelics, Patients, and Clinical Trials This is a in-person event Location: Aquillius 10918 Technology Pl San Diego, CA 92127 Event Description: This session explores the promise of psychedelic therapies through the lens of lived patient experience, regulatory insight, and hands-on clinical trial management. The panel will examine what it truly takes to design clinical trials and Risk Evaluation Mitigation Strategies within psychedelic clinical research. Attendees will gain a practical understanding of how patient voice, regulatory requirements, and real-world trial execution intersect to create safe, scalable access to emerging treatments such as ibogaine and other psychedelic compounds. Speakers: James “Bart” Bartelloni: Chief Revenue Officer, Harvest Connect, LLC Jamie Freedman: Executive Director, Head of Clinical Operations, Definium Therapeutics Rachel Bonfanti: Director, Risk Management and Scientific Consulting, UBC Cynthia LaCivita, Pharm.D.: CLL Consulting, LLC (former Director, Division of Risk Management, CDER, FDA) Learning Objectives: Describe strategies for the design of psychedelic clinical trials to support patient safety and regulatory approval. Explain how clinical trial management practices must adapt to operationalize REMS requirements in studies involving psychedelic therapies, including ibogaine. Understand how integrating lived patient experience can inform both REMS development and practical trial execution to enable safe, scalable access to psychedelic treatments. Event Agenda: 5:30 - 6:00 PM | Networking 6:00 - 7:00 PM | Educational Panel 7:00 - 7:30 PM | Networking Registration Information: This event is free to attend. Click here to register before 3/18/26. Each attendee is required to have their own registration – only one registration per transaction. After registering, please visit the event's community page to find the login information or any additional event updates, and to communicate with the event organizer. The educational portion of this event may be self-reported as 1 point toward an attendee’s Maintenance of Certification. These points are subject to review and acceptance by the Academy of Clinical Research Professionals in accordance with the criteria established. Attendees should keep a record of event participation in case they are randomly selected to participate in the maintenance verification process. The Chapter can provide a certificate of attendance upon request.

Ohio Chapter: 2026 Education Series - Risk Management/Quality by Design

Ohio Chapter: 2026 Education Series - Risk Management/Quality by Design Event Description: Join this one-hour virtual session presented by John R. Wilson, Jr., Ph.D., MPH, for a practical overview of Risk Management and Quality by Design. Learn how proactive, risk-based approaches and QbD principles can be applied to improve quality, reduce issues, and support successful clinical research outcomes. Ideal for professionals involved in study planning, execution, and quality oversight. Speakers: John R. Wilson, Jr., Ph.D., MPH Senior Vice President, Chief Quality Officer Beaufort Event Agenda: Welcome & Introductions (5 minutes) Risk Management & Quality by Design (QbD) (45 minutes) Q&A and Closing Remarks (10 minutes) Registration Information: This event is free to attend. Click here to register before 2/12/26. Each attendee is required to have their own registration – only one registration per transaction. After registering, please visit the event's community page to find the login information or any additional event updates, and to communicate with the event organizer. The educational portion of this event may be self-reported as 1 point toward an attendee’s Maintenance of Certification. These points are subject to review and acceptance by the Academy of Clinical Research Professionals in accordance with the criteria established. Attendees should keep a record of event participation in case they are randomly selected to participate in the maintenance verification process. The Chapter can provide a certificate of attendance upon request.

Suncoast Chapter: Crack the Code: A Comparison of ICH E6(R2) and ICH E6(R3) (ACRP Webinar Replay)

Suncoast Chapter: Crack the Code: A Comparison of ICH E6(R2) and ICH E6(R3) (ACRP Webinar Replay) This event will be presenting a replay sessions from the ACRP Webinar Library Event Description: This 60-minute webinar will help clinical research, regulatory affairs, and Good Clinical Practice quality professionals decode the complexities of the updated guidance. Leslie will break down the key shifts, themes, and differences between R2 and R3, provide real-world examples to simplify the changes, and introduce a framework to help identify gaps and prioritize the next steps for compliance. Speakers: Leslie Sam, BA, CSSBB, CQIA President Learning Objectives: Describe the key principles and structural changes introduced in the updated ICH E6 (R3) guidance. Differentiate major updates between ICH E6 (R2) and R3 and explain how these changes affect clinical research operations and oversight. Interpret real-world examples illustrating how the new guidance applies to clinical trial design, conduct, and quality management. Identify potential compliance gaps within their current Good Clinical Practice processes based on the updated guidance. Apply a practical framework to prioritize next steps for aligning organizational practices with the new regulatory expectations. Registration & ACRP Contact Hour Information: Click here to register and purchase the contact hour before 3/19/26. Each attendee is required to have their own registration – only one registration per transaction. This event will offer 1 contact hour. Please claim your contact hours before 4/19/26. Chapter Member (registration with or without contact hour): $0 ACRP Member (registration only): $15 ACRP Member (registration + contact hour): $30 Non-Member (registration only): $30 Non-Member (registration + contact hour): $105 After registering, please visit the event's community page to find the login information or any additional event updates, and to communicate with the event organizer. To claim contact hours: Register and purchase the contact hours and attend the event. After attending the event, visit learning.acrpnet.org and log into your ACRP account. Click the “GO TO MY COURSES” box. Find the event in your dashboard, confirm your attendance, and take the event evaluation between 1 and 30 days following the event to obtain the online certificate. After 30 days, contact hours are no longer available. JOIN THE TEAMS MEETING!