Track 1: Clinical Safety and Pharmacovigilance
This track, with the overarching theme, Big Data – How to Address and Relevance, has 13 sessions providing an overview of the global regulatory environment in the field of clinical safety and pharmacovigilance for medical products (biopharmaceutical products 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
Sunday, June 24 | Short Courses
- Real World Evidence Studies to Evaluate the Safety and Effectiveness of Therapeutic Interventions – Is the Data Fit for Purpose and How Will You Know?
- The IDMP Challenge: Points to Consider for Pharmacovigilance Departments
- Smart, Innovative, Risk-Based Auditing: Shifting the Paradigm
- Machine Learning in Pharmacovigilance
Monday, June 25
- Cardiac Safety in Drug Development and the Critical Role of Public-Private Partnerships: The Cardiac Safety Research Consortium Model
- Signal Management: Separating Needles From Haystacks
- How Inspection Ready is your Organization?
- Novel Approaches to Clinical Trials Safety and Value Stratification of Data
Tuesday, June 26
- Generic Drug Products: Comparison of Safety Profile with Branded Cousin
- Regulators’ Utilization of Real-World Data in Pharmacovigilance Activities
- Risk Management: New Directions
- Patient Engagement in Pharmacovigilance
- Pharmacovigilance: No Longer Going it Alone
- Challenges and Opportunities in Data Access and Methodology Development for Post-Market Generic Drug Monitoring
Wednesday, June 27
- Automation in Pharmacovigilance: Doing More with Less
- Reducing the Burden of Drug Safety Risk Minimization Programs on the Healthcare System: How Do We Do So and What Has Been Learned to Date?
- Safety Reporting in Interventional Clinical Trials: Convergence of Global Expectations?
- IMEDS: A Collaboration Based on the FDA's Sentinel Initiative
- Artificial Intelligence: A Disruptive Journey for Pharmacovigilance
- Risk Communication and Patient Safety: Recent Learnings and New Approaches
Thursday, June 28
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.