Opening Plenary
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2023 Agenda
Friday, September 29, 2023 at 8:30 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 9:00 to 9:40 Track: Opening Plenary
An update on the FDA 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 9:40 to 10:20 Track: Opening Plenary
An Update from the Health Canada Office of Clinical Trials
Dr. Soltys will provide an overview and discuss the latest developments in the Health Canada Office of Clinical Trial. 003
Presenter: Katherine Soltys, MD, Director, Office of Clinical Trials, Pharmaceutical Drugs Directorate, Health Canada
Break: 10:20 - 10:50
Friday, September 29, 2023 at 10:50 to 11:30 Track: Opening Plenary
Health Canada’s Clinical Trials Compliance and Enforcement: Past, Present and Future
The presenter will provide an overview of Health Canada’s Clinical Trial Compliance Program, including compliance trends and program updates. 004
Presenter: Hocine Abid, MD, Clinical Trial Compliance Program (CTCP) Manager, Regulatory Operations and Regions Branch (ROEB), Health Canada
Friday, September 29, 2023 at 11:30 to 12:10 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. 005
Presenter: Annie Ellis, Research Advocate, Ovarian Cancer Research Alliance