Comprehensive Lifecycle Approaches to Drug Safety, from Clinical Testing to Post-Market Surveillance which Utilize Advanced Signal Detection Methods for Early Identification of Potential Risks and Remains Ahead of Evolving Regulatory Requirements on a National & International Scale
Drug safety and pharmacovigilance executives continually monitor the safety of pharmaceutical and biotechnology products, taking a holistic, lifecycle approach to the identification and mitigation of potential risks to patients in both the clinical as well as post-market, real-world setting. To meet the increasing demands of regulatory authorities, both in the US and abroad, executives work to ensure the detection of potential signals indicating trends in adverse event incidents, to identify, report and remediate safety threats, through the use of multi-channel reporting systems, monitoring of online social media, as well as partnering with physicians and patients to collect safety data. As technology has increased in sophistication and automation takes a greater place in reporting and analysis, drug safety and pharmacovigilance executives are continuously adding new tools to an already robust set of skills, ensuring patient safety remains at the forefront of importance.
The Q1 Drug Safety and Pharmacovigilance Conference will balance several core areas of learning objective for audience members, focusing on the interpretation and implementation of US FDA regulation surrounding safety in clinical studies and post-market surveillance, evolving international requirements with a focus on Europe, as well as the practical approaches needed to collect, analyze and detect potential threats as early as possible. With a focus on risk mitigation throughout, presenters will discuss and debate the best practices for early identification of safety concerns, appropriate and rapid reporting, as well as methods for collection of robust data to support regulatory oversight. Additional topics such as the integration of technology into signal detection, preparation for regulatory inspections and annual report dossier development will also be covered, ensuring a robust, lifecycle approach to product safety.