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Overview
Short Course: January 25, 2023 | Virtual
Short Course: February 1, 2023 | Virtual
Short Course: February 5, 2023 | In-Person
Conference: February 6-8, 2023 | In-Person
DIA's Global Pharmacovigilance and Risk Management Strategies Conference is a neutral event developed by regulators and industry experts discussing the updates, opportunities, and challenges alongside fresh problem-solving strategies that matter most to safety professionals.
Featured
Short Course or Primer
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Jan 25, 2023
Short Course: Aggregate Safety Assessment Planning
Learn more -
Feb 01, 2023
Short Course: Good Pharmacovigilance Practice (GVP) Operations Development - From Clinical Trial to Post Marketing
Learn more -
Feb 05, 2023
Short Course: Pharmacovigilance and Risk Management Planning
Learn more
Who should attend?
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Meeting Designed for
- Drug Safety
- Pharmacovigilance
- Risk Management
- Benefit-risk Assessment and Communication
- Medical Product Safety Assessment
- Post-Market Studies
- Real-World Evidence Generation
- Regulatory Affairs
- Clinical Research
- Data Safety Monitoring and Analysis
- Pharmacoepidemiology
- Medical Information
- Medical Communications
- Medical Affairs
- Health Outcomes
- Patient Engagement
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Learning Objectives
At the conclusion of this activity, participants should be able to:
- Describe the new internationally harmonized guidance on a selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials
- Discuss safety regulatory updates in the U.S, U.K, Europe, Japan, and China
- Recognize MHRA’s progress on updating clinical trial regulations in the UK and its impact on pharmacovigilance activities
- Define FDA draft guidance on the Benefit-Risk Assessment for New Drug and Biological Products for Industry
- Identify new signal detection tools and reinforce the FMQ method and analysis
- Evaluate how regulatory differences impact global risk management organizations and design/implementation of risk minimization materials
- Describe challenges to establishing global approaches to risk minimization and identify risk analysis approaches to developing risk minimization materials
- Analyze recent advances in the use of AI/ML with respect to safety surveillance
- Identify the latest strategies for managing literature requirements at local and global level
- Examine various ways RWE/RWD are utilized in regulatory interactions during clinical development and its role in the evaluation of safety signals arising from clinical trial data
- Explain safety updates and challenges in special population including pregnancy and lactation and transgender population
- Discuss challenges with reaching the minority population and barriers for enrollment in clinical trials and recognize the need for a more inclusive approach within the drug development lifecycle
- Identify potential approaches to address safety challenges in cell and gene therapy and rare disease
- Recognize key concerns smaller companies have encountered with the FDA Final Rule and discuss FDA’s perspective regarding the concerns of smaller pharma companies
Program Committee
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Annette S. Williams, MBA, RPh • Vice President, Pharmacovigilance
IQVIA, United States -
James Buchanan, PharmD • President
Covilance LLC, United States -
Barbara Hendrickson, DrMed, MD • Clinical Associate, Pediatric Infectious Diseases
University of Chicago, United States -
Jeremy Jokinen, PhD, MS • Vice President and Head, Global Risk Management and International Patient Safety
Bristol-Myers Squibb Company, United States -
Susan Kindig, JD, MD • Executive Director, Medical & Drug Safety
Halozyme, United States -
Jamie Ridley Klucken, PharmD, MBA, RPh • Safety Evaluator, Division of Pharmacovigilance, OSE, CDER
FDA, United States -
Annette Stemhagen, DrPH, PhD, FISPE • Chief Scientific Officer and Senior Vice President
UBC, United States -
Mengchun Li, MD, MPA • Senior Director, Clinical Research, Infectious Disease
Merck & Co., Inc., United States -
Sarah Vaughan • Head of Vigilance Development
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom -
Jo Wyeth, PharmD • Associate Director for Postmarket Assessments, OMEPRM, OSE, CDER
FDA, United States -
Cheryl Campbell, MS • Associate Director of Executive Operations/Outreach and Communications, OSE,CDER
FDA, United States
Contact us
Registration Questions?
Additional Information
Discover DIA’s Live In-Person EventsON-DEMAND CONTENT PREVIEW WEBINAR
Planning a Trial with Safety in Mind Aggregate Safety Assessment Plan Obstacles and Opportunities
Preconference Short Courses
Short Course: Aggregate Safety Assessment Planning
Short Course: Pharmacovigilance and Risk Management Planning
Global Pharmacovigilance and Risk Management Strategies Conference Resource Kit
