Overview

January 27-29: Forum

Join us for DIA's Global Pharmacovigilance and Risk Management Strategies Conference, the premier event for advancing your expertise in pharmacovigilance and regulatory affairs. Developed in collaboration with regulators and industry experts, this neutral forum provides unparalleled insights into global regulatory harmonization, AI-driven signal detection, and advanced safety analysis tools. At this conference, you’ll hear about updates, opportunities, and challenges shaping the future of drug safety and learn innovative problem-solving strategies that matter most to safety professionals. Attendees will gain actionable knowledge on integrating patient perspectives, optimizing Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS), and utilizing real-world evidence (RWE) for regulatory submissions and safety monitoring.

This conference also focuses on cutting-edge methodologies for signal detection, benefit-risk assessment, and addressing safety challenges in special populations. An opportunity not to miss to learn best practices for efficient pharmacovigilance operations, including adverse event reporting, outsourcing strategies, and compliance in resource-constrained settings. Register to attend and connect with industry leaders, regulatory authorities, and patient advocates to drive innovation, stay ahead in drug safety, and achieve excellence in regulatory compliance.

Participant Testimonials

This PV and Risk Management conference was the best I've attended in a long time -- content was very current, and speakers provided detailed examples that helped to understand the concepts presented – Peg Fletcher, MD, PhD, President, MedAssessment, Inc.

Always a wonderful conference of some of the best minds in pharmacovigilance and risk management. Cutting edge ideas with all stakeholders included! – Jamie Wilkins, PharmD, Head, Risk Management Center of Excellence, Pfizer Inc.

Very high caliber conference with highly experienced professionals, regulators, and service providers. Great opportunity to learn new skills, understand new technologies and network with peers and vendors. Great job DIA! – Famina Hemani, Vice President, Head of Pharmacovigilance, Tourmaline Bio

Keynote Address!

January 27 | 8:45-9:30AM

Session 1: Keynote Address

The Keynote has Been Released! Tiffany Studebaker-Freeman, Director of Operations and Finance, Paltown Development Foundation

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Welcome Video

Who should attend?

Conference Designed for
- Benefit-risk Assessment and Communication
- Clinical Research
- Data Safety Monitoring and Analysis
- Drug Safety
- Health Outcomes
- Medical Affairs
- Medical Communications
- Medical Information
- Medical Writing
- Medical Product Safety Assessment
- Patient Engagement and Advocacy Groups
- Pharmacoepidemiology
- Pharmacovigilance
- Post-Market Studies
- Quality Assurance
- Quality Control
- Real-World Evidence Generation
- Regulatory Affairs
- Risk Management
- Safety Statistics

Learning objectives

At the completion of this conference, the participant should be able to:
- Analyze global regulatory changes and harmonization efforts across FDA, EMA, MHRA, and other authorities
- Examine AI tools to enhance signal detection, automate literature reviews, and improve safety data analysis within regulatory frameworks
- Recognize patient perspectives to improve decision-making and safety outcomes
- Identify advanced methodologies for RMPs and REMS to optimize patient safety and compliance
- Evaluate real-world evidence (RWE) from claims and electronic health records for regulatory submissions and safety monitoring
- Discuss advanced signal detection methods, such as knowledge graphs and FDA Medical Queries (FMQs), to evaluate safety signals effectively
- Interpret statistical data to assess safety profiles, prioritize risks, and communicate findings accurately
- Recognize how to address safety challenges in special populations, including pediatrics, geriatrics, and rare diseases, through targeted risk assessments
- Describe strategies for efficient pharmacovigilance operations in resource-constrained settings, including adverse event management and outsourcing

Program Committee

James Buchanan, PharmD President
Covilance LLC, United States
Mariette Boerstoel-Streefland, MD, MBA, MS Senior Vice President, Worldwide Patient Safety Officer
Bristol-Myers Squibb Company, United States
Barbara Hendrickson, DrMed, MD Clinical Associate, Pediatric Infectious Diseases
University of Chicago, United States
Mamiko Kasho Executive Director, Global PV Management Dept., Global Safety HQs
Eisai Co., Ltd., Japan
Susan Kindig, JD, MD Prior Executive Director, Medical and Drug Safety
United States
Mengchun Li, MD, MPA Senior Director, Clinical Research, Infectious Disease
Merck & Co., Inc., United States
Mark Perrott, PhD Managing Partner
Axian Consulting Ltd., United Kingdom
Ranjeeta Sinvhal, MD Executive Medical Director, Medical Safety
AbbVie, United States
Bethany Van Veen Pharmacovigilance Consultant
Perspective Pharmacovigilance, United States
Representative Invited DIA, United States