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
Sunday, June 14 | Short Courses
- #21: Real World Evidence Studies to Evaluate the Safety and Effectiveness of Therapeutic Interventions – Is the Data Fit for Purpose and How Will You Know
Monday, June 15
Tuesday, June 16
- Patient-Centricity: How do We Measure Progress in Involving Patients in Drug Development and Drug Safety?
- Disruptive Transformation in Safety Organizations
- Practical Considerations for Robust Evaluation of Risk Minimization Programs: Regulatory, Industry, and Service Provider Insights
- FDA Pre-Market Safety Assessment Program
Wednesday, June 17
- Report of CIOMS DILI Working Group
- Application and Validation of Intelligent Automation Technology in PV: Exploring Opportunities within the Individual ICSR Process
- Immunogenicity of Biologics: Clinical Consequences
- Digital Risk Minimization: How Can We Advance Adoption?
- Quantitative Benefit-Risk Assessment: What Methods Are Being Used? How Far has Industry Come?
- Advancing Risk Management: What Can Evidence-Based Practices to Disseminate Healthcare Evidence into Practice Teach Us?
- Unblinding The New Face of the Local Safety Officer
- MedDRA® Labeling Groupings for Enhanced Communication of Safety Concepts: Cinderella’s Glass Slipper?
- What Does THAT Mean? Communicating Study Risks and Benefits in Patient-Friendly Language
- The Opioid Epidemic: Top Ten Lessons in Regulatory Science
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.