Track 1: Clinical Safety and Pharmacovigilance
This track, with the overarching theme, Big Data – How to Address and Relevance, has 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?
- Machine Learning in Pharmacovigilance
- A Novel Interactive Safety Graphic to Evaluate Potential Drug-Induced Hepatotoxicity
- Interdisciplinary Safety Evaluation During Product Development
Monday, June 24
- Addressing Heterogeneity of Real World Evidence in Drug Safety
- Moving Forward in EU Pharmacovigilance
- Using Real World Data to Develop a Safety Monitoring Program and Ensure Pre- and Post-Market Continuity
- Interpretation of New Pharmacovigilance Regulations: Key Insights
- Current Initiatives on Patient Involvement in the Medicinal Product Lifecycle: CIOMS XI
- Incorporating Systems-Theory and Human Factors into the Investigations of Serious Harm in Clinical Research
Tuesday, June 25
- To Err is Human: Progress and Challenges in the Prevention of Medication Errors
- Updates and Lessons Learned from Novel Approaches to Pharmacovigilance Collaboration
- Emerging Safety Challenges in New Oncology Treatments
- An Industry Collaboration on Pharmacovigilance Analytics
- Pharma and Regulatory Perspectives on Machine Learning Applications in Pharmacovigilance
- Structured Evidence Planning, Production, and Evaluation (SEPPE): A “Quality-Based” Framework for Drug Development
- The Elephant in the Room: Meaningful Communication of Near Synonyms as Suspected Adverse Reactions
Wednesday, June 26
- Digital Risk Minimization: The “Next Generation” Risk Management Tools
- So Much Data, So Little Time: Hot Topics in Benefit-Risk Assessment
- Triple-s (3S) Smart Safety Surveillance
- History of Risk Evaluation and Mitigation Strategies (REMS): What Have We Learned?
- From Trials to Real World: How Safety Protocols Impact REMS
- Involving Patients in Medicinal Product Benefit-Risk Communication: How're We Doing?
- Successes and Challenges in Pharmacovigilance for Biologics and Biosimilars
Thursday, June 27
Take a look at our video interview from DIA 2018 as Howard Chazin, Director of Clinical Safety Surveillance Staff in the Office of Generic Drugs, CDER, who chaired the session, "Generic Drug Products: Comparison of Safety Profile with Branded Cousin," explains how FDA interprets regulation and safety reporting requirements for generic drugs.
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.