The requirement of a DSUR (development safety update report) and PSUR (periodic safety update report) is covered.
Objectives of the Presentation:
- Meet regulatory requirements for product safety
- Signal detection algorithms and methods used
- Hazard modeling
- Collect, assess and report adverse events
- DSURs and PSUR requirements
- Identify differences between U.S. and European regulatory requirements
Why Should you Attend?
Timely reporting and management of serious adverse events (SAEs) in clinical trials is vital to patient safety and compliance with regulatory requirements. One of the reasons for good clinical practice (GCP) is to protect the subjects in a research trial. In all research the subjects’ well-being should be paramount. Safety checks, procedures, and reporting are fundamental to any research study involving human subjects. This includes the timely detection and management of, adverse events (AE), serious adverse events (SAE), adverse reactions (AR), and suspected unexpected serious adverse reactions (SUSAR).
In addition, excellent record keeping, follow-up, and reporting are essential so that appropriate decisions can be taken relating to study participants as well those which help steer the course of the study, based on emerging safety information. It is also important to collect safety information even when a treatment is on the market. In fact many marketing authorization procedures require PASS studies be performed (post authorization safety studies) in order to collect additional safety information. PSURs (periodic safety update reports) are required for post marketed drugs and companies having an obligation to collect any safety information for the lifetime of the product.
- AE, SAE, AR and SUSAR defined
- How to determine causality
- Reporting timelines
- Sources of information, preclinical clinical, clinical and post marketing
- Changes in the regulatory environment i.e. conditional approvals
- PASS and PAES
- Regulatory reports DSURs PSURs
- Signal detection and hazard modeling
- Differences between US and EU requirements
Pharmacovigilance is the surveillance for collection of data about assessment of, and prevention of adverse effects of pharmaceuticals, biological compounds, vaccines, and medical devices. During both clinical development and after marketing approval has been granted, it is the pharmacovigilance function under which collection and analyses takes place of information regarding adverse events, as well as their Evaluation and mitigation using Risk Evaluation and Mitigation Strategies (REMS) programs.
While clinical safety concerns the collection, processing, and analysis of adverse event reports from investigators using the product in the tightly controlled setting of clinical research, post-marketing safety concerns these same activities in the context of how the product is actually used in the community. Distribution of the product is wider, and while some safety information from development programs are helpful, the clinical development setting does not allow for the detection of relatively infrequent events-a key component of post-marketing approval safety activities.
Sue Fitzpatrick Associates
Sue Fitzpatrick has more than 30 years' Pharmaceutical Industry experience. She has been responsible for the management and audit of CRAs, CROs and clinical trials in a wide range of therapeutic areas. As former Director and Head of Education and Training at the Institute of Clinical Research she was responsible for the provision of training courses for the industry and for postgraduate courses in collaboration with several UK Universities. Sue is an accredited teacher with Cranfield University and continues her collaborations but as a consultant trainer. Sue conducts courses in many topics including risk based monitoring (RBM).
Sue is currently a Director of Redtree People and continues her work on enhancing competencies and standards, writing industry gold standards for CRAs in collaboration with COGENT the sector skills council. She was a member of the GCP committee of the Faculty of Pharmaceutical Medicine and helped develop a certification examination for physicians and other research personnel. She is a senior collaborative consultant for NNEdPro Cambridge Hub. She has authored many articles and books on clinical research, risk based/centralized monitoring and career development topics. Sue has recently published a book in Clinical and Healthcare Research with the Oxford University Press.
- Clinical Research Professionals
- Compliance Departments
- Regulatory Departments
- Drug Safety Professionals
- Pharmacovigilance Professionals
- Research and Development
- Quality assurance/compliance
- Any personnel that may be involved in safety reporting when conducting clinical trials or following the marketing authorization of a product
- Anyone who would like to enhance their knowledge and understanding of drug safety