Drug Safety & Risk Management
Friday, June 14, 2013 | ARCHIVE NOW AVAILABLE
Drug safety has become one of the most challenging public health issues.
Patients, physician, health care organizations are all responsible for monitoring the potential
side effects caused by drugs.
Pharmaceutical companies are making great efforts to ensure the safe use of medication through product labeling, risk management and post-marketing safety surveillance.
In the fall of 2007, Congress passed the FDA Amendments Act (FDAAA), mandating FDA to establish an active surveillance system for monitoring drugs, using electronic data from healthcare information holders. Its goal is to build and implement a new active surveillance system that will eventually be used to monitor all FDA-regulated products.
This webinar will discuss the new European Union (EU) Pharmacovigilance legislation to ensure compliance and evaluate the optimal risk management plan (RMP),Risk Evaluation and Mitigation Strategies (REMS) for EU and US submissions.
Periodic-Benefit Risk Evaluation report, PBRER represents a significant change from the previous format and has a taken a quantum leap forward towards a document incorporating many new concepts including an integrated evaluation of both benefits and risks of a medicinal product. How to implement the PBRER to encompass multiple functions will also be discussed in this session.
• Risk Management for Pharmaceutical Products
• Risk Management Cycle
• New EU Pharmacovigilance Legislation
• RMP and REMS
• Leap from PSURs to Benefit Risk Evaluation (PBRERs)
A live Q&A session with the audience will follow the main presentation.
Amy Sun, MD, Ph.D., FACP
Director of Clinical Risk Management
Dr. Sun, a Fellow of American College of Physician, is Board certified in Internal Medicine with specialty training in Endocrinology and Clinical Pharmacology, and with a Ph.D. in Molecular Pharmacology. Dr. Sun has extensive experience in managing both early and later phase global clinical trials, clinical safety and post marketing pharmacovigilance across therapeutic areas, including endocrinology, oncology, women’s health care and cardiovascular diseases. She has contributed to numerous NDAs, INDs, and global regulatory submissions, which lead to the market launch of a number of therapeutic agents.
As director of Clinical Risk Management at Merck, Dr. Sun is responsible for the overall safety of oncology compounds the company is developing or marketed. She is skilled in leading matrix Risk Management Strategic Teams, applying FDA/ICH guidelines for clinical evaluation of drug safety, working with Medical Affairs in supporting product scientific and business strategy, and responding to worldwide regulatory inquiries.
Dr. Sun has diverse work experiences. She has worked in academic institution, federal government organization, consumer product company and private practice.Dr. Sun graduated from SouthEast University Medical School in China, completed her medical residency at Creighton University, and endocrinology fellowship at the National Institutes of Health.