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Time Zone Preference
(UTC-04:00) Eastern Time (US & Canada)
Tuesday, September 29, 2026
10:00 AM - 10:05 AM (EDT)
Welcome and Opening Remarks
• Michelle Webb - Vice President, Avoca Quality Consortium - Avoca, A WCG Company
10:05 AM - 10:20 AM (EDT)
Keynote Speaker
• Jonathan Rowe, PhD, MS, MA - Senior Consultant - AQC
10:20 AM - 10:35 AM (EDT)
Fireside Chat with Patient Advocate
• Matthew Stary - Patient Advocate
• Kristen Bennett - Director, Client Delivery - Avoca, A WCG Company (Moderator)
10:35 AM - 11:20 AM (EDT)
Panel Discussion: Designing Risk-Based Quality: Embedding Patient-Centric Thinking from the Start
• Jonathan Rowe, PhD, MS, MA - Senior Consultant - AQC (Moderator)
• Keyhan Afaghi - Director, Clinical Quality Assurance - Corcept
• Jamie Harrop - Vice President, Clinical Operations - Beam Therapeutic
• David Hilfiker - Sr. Director, Risk Based Quality Management, R&D Operations - Daiichi Sankyo
• Ida Holme, MD - Director in Clinical Risk Management and Oversight - Novo Nordisk
• Rachel Jones, MS, CCRP - Director, Clinical Research Operations and Strategy - CARTI
11:20 AM - 11:25 AM (EDT)
Break
11:25 AM - 12:10 PM (EDT)
Panel Discussion: Strengthening Oversight Through QA–Operations Partnership
• Jill Johnston, CCRA, CPM - Chief Innovation Officer - WCG (Moderator)
• Nona Dokuzova - Head, Third Party Quality R&D Quality and Risk Management - GSK
• Phill Gallacher - Senior Vice President, Head of Clinical Operations & Program Management - Cullinan Therapeutics, Inc.
• Danial Hassan - Compliance Officer & Project Manager - Revival Research Institute
• Lauren Scott Kernodle - Head of R&D Quality - BioMarin
12:10 PM - 12:40 PM (EDT)
Networking / Refresh Break
12:40 PM - 12:55 PM (EDT)
AQC Industry Survey Findings and Perspectives
• Michelle Webb - Vice President, Avoca Quality Consortium - Avoca, A WCG Company
12:55 PM - 1:40 PM (EDT)
Panel Discussion: Intelligent Quality: Leveraging AI to Drive Better Trial Outcomes
• Mette Andersen - General Manager - WCG (Moderator)
• Christopher Romero, MD, PhD - Medical Director and Principal Investigator - Headlands Research
• Donald Thampy - Associate Vice President, Head Data Integration and Automation - Merck
• Catalina Tirna - Head of Process and Risk Surveillance - Novartis
• Vimi Shukkoor - Advisor, Medical Quality Systems - Eli Lilly and Company
1:40 PM - 1:45 PM (EDT)
Break
1:45 PM - 2:30 PM (EDT)
Panel Discussion: The Inspection Readiness Challenge: E6(R3), AI, Decentralization, and Beyond
• Jenny Martin - Senior Consultant - AQC (Moderator)
• Natasha E. Ballard, MD, DABFM, FAAFP - Principal Investigator - M3 Wake Research
• Laure Lequesne - Head of Clinical Projects Quality Management - Sanofi
• Paula Markos - Director II, RDQA Inspection Management - AbbVie
• Dave Nickerson - Head of Clinical Quality Management - EMD Serono
Wednesday, September 30, 2026
10:00 AM - 3:00 PM (EDT)
AQC Members Only - AI, Quality, and ICH E6(R3): From Principles to Practice
• Corey Alexander, MBA - Global Head CQA Technologies, Innovation, and Operations - Novartis
• Brian Barnes - Director, Governance Excellence & Risk Management - BioNTech
• Karen Harvey - Senior Director, Avoca Quality Consortium - Avoca, A WCG Company
• Jonathan Rowe, PhD, MS, MA - Senior Consultant - AQC
More details to be announced