Pharmacovigilance and Risk Management Strategies Conference - 2019

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Pharmacovigilance & Risk Management Strategies Conference 2019


Pharmacovigilance & Risk Management Strategies Conference 2019 is a conference dedicated to controversies, complexities and other topics in the area of Pharmacovigilance and risk management. It provides the strongest context, background, updates, new developments, and future direction for regulations and guidance on drug safety, pharmacovigilance, and risk management strategies that cannot be found in any other meeting. The content of this event is developed by top experts from the biopharmaceutical industry and global regulatory agencies, and DIA will convene the best speakers from around the world to discuss the current challenges and issues that matter most to professionals working in the field.


January 21: Short Courses

January 22-24: Conference

Learning Objectives

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

  • Apply the current regulatory framework for pharmacovigilance in key markets, including the US and the changing EU
  • Examine the influence of recent regulatory developments and expectations in Japan, Canada, and Eurasia on safety and pharmacovigilance practice
  • Discuss changes in pharmacovigilance and risk management resulting from the emergence of new and advanced technologies and therapies such as CAR-T cells, monoclonal antibodies, and gene therapy
  • Describe pharmacovigilance and risk management considerations and approaches for combination products and rare disease therapies
  • Apply frameworks and learnings from recent government and industry initiatives to improve safety monitoring and reporting in clinical trials
  • Discuss challenges posed by the changing nature of safety data and the implications of new guidelines, such as the developing ICH E19 Guideline, and new approaches to pharmacovigilance and risk management, such as Artificial Intelligence/Machine Learning

Program Committee

  • Stella Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP Vice President, Global Head of Early Access and Risk Management IQVIA, United Kingdom
  • William Gregory, PhD Safety and Risk Management Pfizer Inc, United States
  • Mariette Boerstoel-Streefland, MD Senior Vice President, Head Global Drug Safety Shire, United States
  • Cheryl Campbell, MS Associate Director of Executive Operations/Outreach and Communications, OSE,CDER FDA, United States
  • Mick Foy Head of Pharmacovigilance Strategy, Vigilance Intelligence and Research Group Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
  • E. Stewart Geary, MD Senior VP, Chief Medical Officer, Director, Corporate Medical Affairs HQ Eisai Co., Ltd., Japan
  • Lisa Melanie Harinstein, PharmD Team Leader, Division of Pharmacovigilance I, OSE, CDER FDA, United States
  • Stephen Knowles, MD, MRCP Vice President, Drug Safety and Pharmacovigilance Halozyme Therapeutics, United States
  • Barbara Morollo Head, Pharmacovigilance Operations Moderna Therapeutics, United States
  • Simone Pinheiro, PhD Lead Epidemiologist FDA, United States
  • Michael Richardson, MD, FFPM International GPV&E and EU QPPV Bristol-Myers Squibb, United Kingdom
  • Annette Stemhagen, DrPH, FISPE Senior Vice President, Safety, Epidemiology, Registries & Risk Management UBC, United States
  • Lesley Wise, PhD, MSc Managing Director Wise Pharmacovigilance and Risk Management Ltd, United Kingdom


DIA - Drug Information Association


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