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.
Featured
Short Course or Primer
-
Jan 10, 2022
Short Course 1: Reference Safety Information
Learn more -
Jan 12, 2022
Short Course 2: Aggregate Safety Assessments
Learn more -
Jan 14, 2022
Short Course 3: Getting Real About Inspections
Learn more
Who should attend?
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, Worldwide Safety Officer
Bristol-Myers Squibb Company, 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 Company, 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 Operations
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
Contact us
Registration Questions?
Preconference Short Courses
Short Course 1: Reference Safety Information
Short Course 2: Aggregate Safety Assessments
Short Course 3: Getting Real About Inspections
Discover DIA’s Live In-Person and Live Virtual Events