Track 1: Clinical Safety and Pharmacovigilance
This track provides an overview of the global regulatory environment in the field of clinical safety and pharmacovigilance for medical products (biopharmaceutical products, advanced therapies and medical devices), with a focus on pragmatic approaches to protecting patient safety and incorporating the patient voice into the complex and evolving pharmacovigilance ecosystem. Forward-thinking sessions address the application of new technologies and methods to streamline pharmacovigilance systems and processes to enhance protection of patient safety as products become more complex, new data sources drive new analytical techniques, regulatory requirements become more detailed, and medical product development becomes more global.
Sessions in Clinical Safety and Pharmacovigilance
Monday, June 21-Friday, June 25 | Short Courses
Monday, June 28
- Safety Compliance
- COVID-19 Real-World Data Analysis and Vaccine Surveillance: Examples from FDA and the Danish Medicines Agency’s Approaches
- Artificial Intelligence: Real Applications and Regulatory Perspectives
- Are You Ready for a NISS? Industry and Regulatory Perspectives on the US FDA Newly Identified Safety Signal Process
- A Journey of Interdisciplinary Collaboration to Improve Safety Evaluation in Drug Development
Tuesday, June 29
- Assuring Access to Safe Medicines in Pregnancy and Lactation: International Regulators Perspective
- Systems Thinking: A Better Way of Safety Management Planning
- Aggregated Clinical Safety Evaluation Utilizing Real-World Data and Randomized Clinical Trial for Safety Decision-Making
- Treating Covid-19 Patients with Unproven Interventions Outside Trials: EUAs, Expanded Access, Right to Try, and Off-Label Use
Wednesday, June 30
- From Opportunity to Strategy: Introducing Intelligent Automation Technologies within Pharmacovigilance for the ICSR Process
- Risk Minimization Program Evaluation: How Can We Advance the Science?
- Trends and Analysis of Combination Product Safety Reports Submitted to FDA
- Patient-Focused Benefit-Risk Assessment and Risk Management: Methodology for Engaging with Patients: What has Been Learned?
Thursday, July 1
- Development of Shared System and Shared REMS: Best Practices and Lessons Learned
- The Spirit of the IND Safety Reporting Final Rule
- What is the Breakthrough Risk Communications and Assessing Safety After Early Access to Pharmaceuticals?
Who is This Track Designed For?
Professionals involved in: drug safety/pharmacovigilance, medical product safety risk assessment, pharmacoepidemiology (including real world evidence generation), post-market studies (including Large Simple Safety Studies and pragmatic safety studies), statistics, benefit-risk assessment and management, benefit-risk communication (including professional and consumer medical product safety labeling), regulatory affairs, clinical research (including clinical trial design), medical affairs, and health outcomes.