戻る Agenda
Advances in Evidence-based Quality and Risk Management for Pharmacovigilance Decisions Making
Session Chair(s)
Marina Alexandra Malikova, PhD, MBA, MS, RAC
Executive Director, Translational Research, Assistant Professor of Surgery
Boston University School of Medicine, United States
Major regulatory pharmacovigilance decisions (suspension, withdrawal, revocation) have high impact on serious morbidity, mortality and health of patients. This impact remains mostly unquantified. It must be measured quantitatively. Quantitative measurement of the impact of major pharmacovigilance actions does not only allow assessing the benefits of the actions taken, but informs the debate and improves future pharmacovigilance decisions. While progress has been made at clarifying the issues that arise most frequently, regulatory authorities and product developers continue to struggle with complex regulatory and technical issues encompassing the development programs for cellular therapeutics as combination products. A risk based approach requires not only a strategy but also tools to define key indicators to measure specific risks. Clinical perspective for drug repurposing for treatment of COVID-19, decision making and safety monitoring will be discussed. Key risk indicators (KRIs) and risk based quality management systems with focus on safety of research subjects and data integrity will be reviewed.
Learning Objective : Review applicable regulatory updates for safety management throughout lifecycle of biomedical products; Discuss strategy to develop relevant metrics/ indicators for risk based quality management (RBQM) in trials; Discuss drug repurposing and safety monitoring for treatment of COVID-19 and provide clinical perspective; Learn about major regulatory decisions in PV such as product withdrawal and methods, quantitative measurements of such decisions on public health
Speaker(s)
Drug Repurposing for COVID-19 Treatment and Safety Monitoring: Clinical Experience
Tejal S. Brahmbhatt, MD
Boston Medical Center, United States
Assistant Professor of Surgery
Safety and Risk Based Quality Management in Clinical Trials with Cell Based Combination Products
Marina Alexandra Malikova, PhD, MBA, MS, RAC
Boston University School of Medicine, United States
Executive Director, Translational Research, Assistant Professor of Surgery
Quantitative Measurement of the Impact of Major Pharmacovigilance Decisions
Saad Shakir, MD, FFPM, FISPE, FRCP
ADROITVIGILANCE, United Kingdom
Pharmacovigilance Physician and Pharmacoepidemiologist
CAR T cells – Tension between Bio/Hemo- & Pharmako-Vigilance
Stefan Kaehler, PharmD, MPharm
Celgene A Bristol Myers Squibb Company, Austria
Exec. Dir QPPV