Chrissy Cochran completed her PhD from University of Maryland Baltimore and postdoctoral studies from Johns Hopkins University School of Public Health. She is the director of the Division of Enforcement and Postmarketing Safety, in the Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration. She has published more than 10 papers in reputed journals and presented more than 30 abstracts.
In September 2013, the United States Food and Drug Administration’s (US FDA) Commissioner began an initiative to organize US FDA inspectors along regulated commodity areas, such as pharmaceutical or device manufacturing, food processing, or bioresearch monitoring (human subject protection, clinical trial data reliability, compliance with US FDA postmarketing safety regulations). Increased specialization and dedication of inspectors in the bioresearch monitoring program will result in inspectors gaining more in-depth knowledge of regulations and industry practices and trends. This will enable inspectors to refine the unique skills needed to conduct inspections, and provide reliable data to support the US FDA’s decision to approve US FDA regulated products. In turn, the change will result in higher quality inspections of US FDA regulated products. The poster presentation will discuss the objectives of the bioresearch monitoring program, purpose of the Commissioner’s initiative, and the plan to implement a vertically integrated commodity based program. The outcome of the Commissioner's initiative is greater protection of public health regarding US FDA regulated products.
Mario Bertazzoli is a physician and a registered specialist in Human Reproduction Pathology. He received both medical and specialization degrees from the University of Milan, Italy. He worked since 1995 for international pharmaceutical companies as pharmacovigilance and pharmaco-epidemiology physician. He is currently the Head of Corporate Drug Safety and Reference Physician to the EU Qualified Person for Pharmacovigilance for the Helsinn Group. He is founder and treasurer of the International Society of Pharmacovigilance, Swiss-Austrian Chapter.
A continuous evaluation of the positive therapeutic effects of a medicinal product in relation to the risks is of paramount relevance also for a mature drug that has been on the market from many years. Regulatory Authorities may at any time ask the marketing authorization holder to forward data demonstrating that the benefit-risk balance remains favourable and it is continuously assessed. Nimesulide is a COX-2 preferential NSAID characterized by a particularly rapid onset of analgesic action. The widespread nimesulide post-marketing use has contributed to better understand its favourable safety profile. However, the extensive use of a drug poses unique challenges since even a rare but severe risk can have a significant impact on the population. A safety referral under Article 31 (Directive 2001/83/EC) may be initiated in specific cases where the interest of the public health in the European Union is involved, for example following concerns related to the benefit-risk balance of a medicinal product.The actions taken to keep the possible risk under control regarded the conduction of non-interventional studies, education of prescribers on the correct use of the drug and risk minimization actions.The efficacy of these actions has been monitored through drug utilization studies that have shown how nimesulide is, in the vast majority of cases, prescribed according to the approved label.