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 23 | 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
- Implementing a Risk-Based Monitoring Solution: Understanding the Basics of a Sustainable Model
- Smart, Innovative, Risk-Based Auditing: Shifting the Paradigm
- Machine Learning in Pharmacovigilance
Included Topic Areas in Clinical Safety and Pharmacovigilance
DIA 2018’s Program and full list of sessions will be available in January. Meanwhile, see what topics and priorities we are designing content for.
- Practical applications of real world evidence
- Hands on applications and practical messages
- Use of pharmacoepidemiology in assessment of safety issues
- Use of data and assessment in product issues
- How can databases be used?
- Use of external databases
- Effectiveness of risk minimization effort
- Risk management plans
- Signal detection and management
- Implications of automation
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.