Opening Plenary
Download Breakout Session Overviews | Download Schedule of Breakout Sessions | View Conference Schedule
2023 Agenda
Friday, September 29, 2023 at 9:00 Track: Opening Plenary
Welcome and Introduction
Ms. Li and Ms. Rowe will describe issues related to the practice of clinical research in the current regulatory environment and how SOCRA works to promote education and training within the clinical research community. 001
Presenter: Jennifer Li, BSc, CCRP, Quality Assurance Supervisor, Princess Margaret Cancer Centre
Presenter: Jessica Rowe, MA, MS, CCRP, CIP, Associate Director, HRPP and YCCI, Regulatory Compliance & Quality, Yale School of Medicine
Friday, September 29, 2023 at 9:15 to 10:00 Track: Opening Plenary
An update on the FDA's ORA’s BIMO Program
The presentation will cover organizational developments including personnel updates, key indicators and performance measures in the OBIMO program. Ms. Johnson will also discuss upcoming projects from BIMO to benefit stakeholders. 002
Presenter: Anne E. Johnson, BA, District Director for FDA Philadelphia District Office, Program Division Director of Bioresearch Monitoring Operations Division I (East), Office of Regulatory Affairs, FDA
Friday, September 29, 2023 at 10:30 to 11:15 Track: Opening Plenary
Health Canada’s Clinical Trial Compliance Program
Dr. Kasian will provide an overview of Health Canada’s Clinical Trial Compliance Program, including compliance trends and program updates. 003
Presenter: Alicja Kasina, MSc, BPharm, , Sr Regulatory Advisor, Clinical Trial & Biologic Comp, Health Canada
Friday, September 29, 2023 at 11:15 to 12:00 Track: Opening Plenary
A Patient’s Perspective on Clinical Trial Participation
Cancer survivor and research advocate, Annie Ellis will discuss factors that led to her interest in clinic trials as well as personal experiences with medical team communication and clinical trial participation. Ms. Ellis will also share perspectives gained from providing peer support and research advocacy. 004
Presenter: Annie Ellis, Research Advocate, Ovarian Cancer Research Alliance