Signal detection is a necessary element of pharmacovigilance, which is mandated by EU regulatory requirements and strongly urged in the US by the FDA. Many tools and techniques can be employed to simplify this process and ensure your product is being proactively monitored.
Signal detection and trending is a powerful method used in the management of drug safety. This webinar will share the process of signal detection (detection, validation, analysis and prioritization, assessment and action) as detailed in the EMA Guideline on Good Pharmacovigilance Practices (GVP) Module IX – Signal Management and will also address the recommendations of the FDA. Additionally, we will focus on ways to tailor your signal surveillance approaches to best benefit your product’s drug safety profile, get the maximum value out of signals and drive patient safety.
Examples of signal detection through a multi-tiered approach will be provided, the roles of key players in the process will be introduced and the speaker will explore how the outcomes of signal detection and trending influence Benefit Risk assessments.
Robin Williams, B.S., CMC, Senior Safety Scientist, Drug Safety Alliance / Ashfield Pharmacovigilance
Robin Williams has over 16 years of experience in the industry, holding positions in clinical reference laboratories, academic research, post-marketing call center management and pharmacovigilance (clinical and post-marketing). Robin is currently a Senior Safety Scientist with Drug Safety Alliance | Ashfield Pharmacovigilance, authoring periodic reports and working closely with safety physicians on signal detection and management for numerous clients. Robin has received advanced training in Signal Detection and Management through DIA and Oracle.Message Presenter
Who Should Attend?
Senior level professionals working on the development of regulated health product such as drugs, RX, OTC, animal health, vaccines, and medical devices
Job functions also include:
- Quality Assurance Professionals
- Pharmacovigilance Professionals
- Qualified Persons (QPPV)
- Drug Safety Officers
- Medical Writing Professionals
- Pharmacoepidemiology Professionals
- Regulatory Affairs Professionals
For pharmaceutical, biotech, cosmetic, and medical device companies
Founded in 2000 and acquired by UDG Healthcare plc in 2012, as part of its Ashfield Division, Ashfield Pharmacovigilance (formerly Drug Safety Alliance) is a global leader in safety and risk management services supporting Pharmaceutical, biotech, medical device, consumer health and animal health organizations. Uniquely focused on pharmacovigilance, we provide comprehensive outsourced solutions and modified services to augment existing safety departments.
Our commitment to pharmacovigilance allows you to focus on your core business, while we partner with you to promote patient safety and product longevity. We achieve this by fostering the open exchange of ideas among organizations throughout the pharmacovigilance community. By delivering innovative approaches to Global Case Management, Aggregate Report Development, Literature Search Services, Signal Detection and Surveillance, Risk Management Services, Safety System Implementation, and Medical Information and Call Center Services, Ashfield Pharmacovigilance is helping to advance the practice of pharmacovigilance on a global scale.