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Track 6: Safety and Pharmacovigilance
With 16 sessions specific to Safety and Pharmacovigilance, this track provides an overview of the global regulatory environment in this field, setting the context for its main focus of examining system-level approaches to resolving complex pharmacovigilance issues of today. Forward thinking sessions address the application of new technologies and methods to streamline pharmacovigilance systems and processes without compromising patient safety as products become more complex, regulatory requirements more stringent, and medical product development more global.
Highlights in Safety and Pharmacovigilance
- Pharmacovigilance systems for vaccines
- Postmarket Safety Studies: Approaches and regulatory insights
- Benefit-risk: Integrated life cycle approaches in assessment, communication, and evaluation
- New considerations in benefit-risk management
- Innovations in communication for physician and patient labeling
- Global safety monitoring regulations – addressing through systematic approaches
- Artificial Intelligence (AI) and redesigning pharmacovigilance for the future
- Automation and innovation in clinical trial safety assessment
- The ongoing globalization of pharmacovigilance and regionally-focused changing environments in pharmacovigilance
- Featured Topics in Risk-Based Monitoring, Patient Centricity, Statistics, and Career Development
DIA recommends this track and associated sessions to professionals involved in: Drug Safety/Pharmacovigilance, Risk Management and REMS, Benefit-Risk Assessment and Communication, Medical Product Safety Assessment, Pharmacoepidemiology, Postmarket Studies and Real World Evidence Generation, Statistics, Regulatory Affairs, Clinical Research, Medical Affairs, MSL, and Health Outcomes.
Sessions in Safety and Pharmacovigilance
Sunday, June 18 | Short Courses
- Signal Detection: Identifying and Managing Safety Signals
- Preparation of Risk Evaluation and Mitigation Strategies Assessment Reports
- Analysis of Safety Data from Clinical Trials
- The Good Pharmacovigilance Practices in the EU: Global Applications
Monday, June 19
Drug Repurposing: Where Will it Take Us?
- Postmarketing Safety Studies: Approaches and Regulatory Insights
- Counting on Safety
- Designing and Implementing a Robust Pharmacovigilance System for Vaccines
Tuesday, June 20
People Will Talk: Gathering Insights from Digital Listening
- New Considerations in Benefit-Risk Management
- Developing Pharmacovigilance Policy Based on Impact
- Safety Evaluation: Transforming Information into Evidence
- Cardiac Safety
- Pharmacovigilance Inspections: Hot Topics and Proactive Approaches
Wednesday, June 21
Does Diversity Matter in Clinical Trials?
- A New Age for Physician and Patient Labeling: Recommendations for Innovative Change in How We Communicate
- Integrated Life Cycle Approaches to Benefit-Risk Assessment, Communication, and Evaluation
- Automation and Innovation in Clinical Trial Safety Assessment
- The Brave New World: The Ongoing Globalization of Pharmacovigilance
- Exploring the Evolution of Signal Detection
- Changing Environments Within Pharmacovigilance
- Pharmacovigilance 2.0: Redesigning for the Future
- IMEDS: A Public-Private Partnership to Facilitate Real World Evidence Generation Based on the FDA's Sentinel System
Progress in Pediatric Therapeutics
Thursday, June 22
Need More on Safety?
DIA’s Learning portfolio offers multiple face-to-face and online opportunities. Our courses provide comprehensive coverage of the full discovery, development, and life cycle management of health care products. DIA’s unique multidisciplinary environment provides learning opportunities not only in participants’ respective fields, but also in related fields—lending new perspectives that help teams collaborate more efficiently and effectively. DIA wants to ensure you’re prepared with the knowledge, solutions, and strategies you need to be successful in in today's complex global regulatory environment.
Upcoming Safety Face-to-Face and Online Learning
- Introduction to Signal Detection and Data Mining
- Oversight of Clinical Monitoring: Trends and Strategies (Who's Monitoring the Monitor?)
- How to Prepare for a Safety Inspection
- Development of a Clinical Study Report
- Clinical Statistics for Nonstatisticians
- New Drug Product Development and Life Cycle Management
- Pragmatic Approaches to Drug Safety across the Premarketing and Postmarketing Continuum
- Advanced Signal Detection and Data Miniing
Upcoming Safety Meetings
- Canadian Pharmacovigilance and Risk Management Strategies Conference
- Pharmacovigilance and Risk Strategies Conference (January 22-24, 2018)