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Overview

January 27: Short Courses
January 28-30: Conference


DIA's Pharmacovigilance and Risk Management Strategies Conference provides the strongest context, background, updates, new developments, and future direction for regulations and guidance on 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.

This conference will give you the foundation for strong strategic planning and practical decision-making in your pharmacovigilance programs, rather than the cookbook approaches often presented elsewhere. In addition to new developments and updates on regional regulations and guidelines, regulators from the US, EU, and other global regions provide the context and thinking behind evolving requirements.

This year, regulators and industry experts will take an in-depth look at global harmonization of ICH E19, addressing optimization of safety data collection.  Insights and forward-thinking approaches to pharmacovigilance and risk management to ensure the safety of existing as well as advanced new therapies as these enter development and the postmarket setting will be discussed.  Projects applying cutting edge technologies like machine learning/artificial intelligence to manage large volumes of potential safety data will be examined. Don't miss this opportunity to interact and converse in an open forum, with regulators and top subject matter experts, on the issues that keep you up at night and serve as roadblocks in your daily job.


While we work on the agenda for 2019, check out our Program from 2018.

Who should attend?

Professionals involved in:

  • Drug Safety/Pharmacovigilance
  • Risk Management, including Risk Evaluation and Mitigation Strategies (REMS)
  • Benefit-risk assessment and communication
  • Medical Product Safety Assessment
  • Regulatory Affairs
  • Pharmaceuticals, biologics, combination products, devices
  • Clinical Research and Clinical Research Organizations
  • Pharmacoepidemiology
  • Post-market studies and Real World Evidence generation
  • Customer Engagement Programs, including Patient Support Programs
  • Medical Information, Medical Communications
  • Health Outcomes
  • Academic Research Centers
  • Regulatory Agencies 
      

Program Committee

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

DIA Learning: 2018 eLearning Soultions
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