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Pharmacovigilance and Risk Management Strategies Conference

Name: Pharmacovigilance and Risk Management Strategies Conference
Start: 2021-01-26T09:45:00+00:00
End: 2021-01-28T17:00:00+00:00

January 26, 2021 @ 9:45 am - January 28, 2021 @ 5:00 pm

DIA’s Pharmacovigilance and Risk Management Strategies Conference provides the foundation for strong strategic planning and practical decision-making in your pharmacovigilance programs. Developed by recognized experts from the biopharmaceutical industry and global regulatory agencies, this conference provides the background, context, and opportunities to discuss current challenges and to problem-solve around issues that matter most to professionals working in the field.

This year’s conference will address the current thinking on predicting and assessing risks such as drug-induced liver injury, and the assessment of expectedness of serious adverse reactions during clinical development. The complexities of assessing benefit-risk balance of today’s therapies, including immunotherapy and other advanced therapies, will be examined. Experts will present approaches and engage in dialogs around more extensive and impactful uses of real world data and generation of RWE for safety assessments. A full day will be devoted to the development, implementation, and assessment of risk management strategies for drugs approved in multiple regions, with a special in-depth coverage of REMS in the US.

In addition to new developments and updates on regional regulations and guidelines, regulators from the US, EU, and other global regions provide the context and thinking behind evolving requirements.

“One of the best conferences I have attended. A broad view on how far we have come in the world of PV, why we do what we do, and what is still to come ot meet future needs of patients and managing benefit-risk.” – Mary Welke, Trilogy Writing & Consulting, Inc

Who should attend?

Professionals with intermediate to advanced knowledge of, and experience in, clinical safety and who are involved in:

Drug Safety/Pharmacovigilance
Risk Management, including Risk Evaluation and Mitigation Strategies (REMS)
Benefit-Risk Assessment and Communication
Medical Product Safety Assessment
Regulatory Affairs
Clinical Research
Pharmacoepidemiology
Post-Market Studies and Real World Evidence Generation
Customer Engagement Programs, including Patient Support Programs
Medical Information, Medical Communications
Health Outcomes

It is also designed for professionals who work for:

Industry: Pharmaceuticals, Biologics, Combination Products, Devices
Clinical Research Organizations, Contract Service Organizations
Academic Research Centers
Regulatory Agencies
Government Research Programs

Members of board, C-level, Senior Vice Presidents, Vice Presidents, Directors and Heads of departments from pharmaceutical involved in:

Drug Safety
Pharmacovigilance
Risk Management
Clinical Safety
Data management and data mining
Safety & Risk Management
Signal Detection
Risk Management
Benefit-Risk Assessment
Safety Evaluation
Regulatory Affairs, Pharmacovigilance
PV Governance
Safety Surveillance
Pharmacovigilance Operations
PV Inspection and Audit Readiness
Patient Support Programs
Market Research Programs
Medical Safety
Medical Information
Pharmacoepidemiology

Details

Start:: January 26, 2021 @ 9:45 am
End:: January 28, 2021 @ 5:00 pm
Event Category:: Bio
Website:: https://www.diaglobal.org/en/conference-listing/meetings/2021/01/pharmacovigilance-and-risk-management-strategies-conference-21002