Track 01 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.
DIA recommends this track and associated sessions to 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.
Included Topic Areas
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New initiatives, and emerging regulatory requirements and expectations regarding drug safety-related policies, processes and best practices, and quality metrics, especially those relating to patient engagement; data privacy; Good Pharmacovigilance Practices (GVPs), including insights into revised modules; pre- and post-market safety; expansion of ICH (International Council for Harmonisation) “E2” guidelines to developing markets; benefit-risk assessment and management; epidemiologic studies and impact on labeling; safety considerations for combination products, medical devices, generic products (including biosimilars), and advanced therapies; companion diagnostics; pharmacovigilance audits/inspections; use of digital technology for risk identification, minimization, and communication; patient-centric labeling and risk minimization methods; application of artificial intelligence to pharmacovigilance; generating meaningful insights on medical product safety from social media and other new data sources; optimizing the global pharmacovigilance footprint (including local safety offices and partners); and considerations for signal detection and management across the product lifecycle. Topics related to bioethical issues in clinical safety and pharmacovigilance are also welcome and may be considered for a special track in the meeting.
- Update on Regulations and Cross-Industry PV Initiatives
- Special PV Considerations
- Transforming the Drug Safety Organization
- Benefit-Risk Assessment and Risk Management
- Artificial Intelligence in Pharmacovigilance
- Future Directions in Patient Safety
Sessions in Clinical Safety and Pharmacovigilance
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