Pharmacovigilance and Safety
Overview of the global regulatory environment for clinical safety and pharmacovigilance for medical products (biopharmaceutical products, advanced therapies and medical devices).
The focus is on pragmatic approaches for ensuring patient safety and ensuring that the patient voice is properly heard in the complex and evolving pharmacovigilance ecosystem. The forward-thinking sessions will address how to apply new technologies and methods for streamlining pharmacovigilance systems and processes. This will help enhance patient safety as products become progressively more complex, new data sources drive new analytical techniques, regulatory requirements.
Who is This Track Designed For?
Professionals involved in drug safety/pharmacovigilance, medical product safety risk assessment, pharmacoepidemiology (including real-world evidence generation), post-marketing studies (including Large Simple Trials and pragmatic safety studies), statistics, benefit-risk assessment and management, benefit-risk communication (including professional and consumer medical product safety labelling), regulatory affairs, clinical research (including clinical trial design), medical affairs and health outcomes.
The online program is now available. Explore the rich content we offer across 10 thought leadership tracks.
Álmath Máire Spooner, PhD, RPh
Director of Regulatory Policy and Intelligence
Raphael Van Eemeren
EU QPPV Director, Global Patient Safety
Amgen AB, Sweden
Day 1: Tuesday, March 29th
Risk Management Through the Product Lifecycle – From Strategy to Implementation
Case Studies for AI-Based Intelligent Automation in Pharmacovigilance
80/20 – Getting 80% of Safety Work Done at the Ingestion Step
Day 2: Wednesday, March 30th
Assessing Exposures to Medicines During Pregnancy: An Evolving Landscape
"Tipping the Balance’’ – The Level of Technology vs Human Intervention Deployed in the Identification of Safety Risk in Data Sources
Day 3: Thursday, March 31st
DIA Europe 2022 Highlights
It will provide updates on key developments on the GCP Renovation (ICH E6, ICH E8), Clinical Trial Regulation, the Clinical Trial Information System, data submission, transparency, navigating ethical approval, study design in the digital age, innovative clinical trial designs (umbrella and platform trials, patient centricity), digital tools in development and other hot topics. It should be a must-attend for optimising development programmes and identifying cost savings through efficiency and innovation.