Pharmacovigilance and Risk Management

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Overview

January 10: Short Course
January 12: Short Course
January 14: Short Course
January 24-26: Conference

For pharmacovigilance professionals, the complexity of monitoring safe medicinal practices are heightened by the rapid development of multiple vaccines and treatments, the emergent nature of knowledge regarding COVID-19, and pervasive misinformation about prevention and treatment practices. Current challenges will have lasting impacts on safety, pharmacovigilance, risk management, and more.

DIA's Global Pharmacovigilance and Risk Management Strategies Conference was developed by recognized experts from the biopharmaceutical industry and global regulatory agencies. This conference provides the background, context, and opportunities to discuss current challenges alongside fresh problem-solving strategies that matter most to professionals working in the field.

2022's Global Pharmacovigilance and Risk Management Strategies Conference invites stakeholders from medicines research, global regulation, and healthcare will join to analyze current challenges for safety in pharmacovigilance efforts, and examine effective strategies for addressing gaps and needs. These new approaches and collaborations build on the foundation of sound pharmacovigilance principles to optimize safety and pharmacovigilance practice, and ensure safe medicines for patients in a global and regional context.

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Want to learn more about DIA Global Pharmacovigilance and Risk Management Strategies Conference? You've come to the right site!

Continuing Education

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Exhibits

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Highlights & Features

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Short Course or Primer

To keep you at the forefront.

Jan 10, 2022

Short Course 1: Reference Safety Information
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Jan 12, 2022

Short Course 2: Aggregate Safety Assessments
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Jan 14, 2022

Short Course 3: Getting Real About Inspections
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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
Post-market studies and Real-world evidence generation
Regulatory affairs
Clinical research
Data safety monitoring and analysis
Pharmacoepidemiology
Medical information, Medical Communications, Medical Affairs
Health outcomes
Customer Engagement Programs, including Patient Support Programs

It is also designed for professionals who work in the settings of:

Industry: pharmaceuticals and biologics
Clinical Research Organizations
Academic Research Centers
Regulatory Agencies

Learning objectives

At the conclusion of this activity, participants should be able to:

Describe the requirements for the use, management, and documentation of the reference safety information (RSI) in clinical trials and how they are enforced by regulatory agencies
Identify the key descriptive and analytical statistics, their use in interpreting measures of risk, and how estimands can be applied to safety analyses
Analyze, implement pharmacovigilance inspection preparedness
Discuss the factors which predict susceptibility to believe misinformation and identify potential interventions to reduce the sharing of misinformation
Outline the key principles and skills necessary for an effective communication strategy
Examine the complexities in management of sudden peaks and unprecedented volume of adverse events, discover solutions to deal with sudden peaks in volumes
Discuss current-state and potential future applications of AI in PV as well as the regulatory challenges and implications
Recognize challenges and opportunities that occur in prospective pregnancy registries and bring to understanding drug safety during pregnancy
Integrate RMP and REMS regulatory update information into work practices

Program Committee

Stephen Knowles, MD, MRCP • Chief Medical Officer
Halozyme Therapeutics, United States
Annette S. Williams, MBA, RPh • Vice President, Pharmacovigilance
IQVIA, United States
Mariette Boerstoel-Streefland, MD, MBA, MS • Senior Vice President Patient Safety, Chief Safety Officer
AstraZeneca, United States
James Buchanan, PharmD • President
Covilance LLC, United States
Cheryl Campbell, MS • Associate Director of Executive Operations/Outreach and Communications, OSE,CDER
FDA, United States
E. Stewart Geary, MD • Senior Vice President
Eisai Co., Ltd., Japan
Jeremy Jokinen, PhD, MS • Vice President and Head, Global Risk Management and International Patient Safety
Bristol Myers Squibb, United States
Jamie Ridley Klucken, PharmD, MBA, RPh • Safety Evaluator, Division of Pharmacovigilance, OSE, CDER
FDA, United States
Linda J. Scarazzini, MD, RPh • Vice President, Pharmacovigilance and Patient Safety
AbbVie, United States
Sarah Vaughan • Head of Vigilance Development
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Annette Stemhagen, DrPH, PhD, FISPE • Chief Science Officer
UBC, United States
Jo Wyeth, PharmD • Associate Director for Postmarket Assessments, OMEPRM, OSE, CDER
FDA, United States