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Omni Shoreham Hotel

Jan 28, 2019 7:00 AM - Jan 30, 2019 3:00 PM

2500 Calvert Street NW, , Washington, DC 20008 , USA

Pharmacovigilance and Risk Management Strategies Conference

NEW! The 2019 meeting will be a full three days, allowing maximum learning opportunities!


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 post-market 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.

Preconference Short Courses


  • Three full days for maximum learning opportunities
  • Global Regulatory Updates
  • Daily Keynote Speakers
  • Luncheon Round Table Discussions with Key Thought Leaders
  • Short Course offerings on Sunday, January 27

On-Demand Complimentary Webinar

Encore Presentation of Exploring the Evolution of Signal Detection
Since the initial release of GVP Module IX - Signal Management, pharmacovigilance organizations have gained a considerable amount of experience. The EMA has released Module 9 R2, which incorporates the key learnings to date. This webinar will explore notable changes, advances in signal management, and how organizations are adapting to meet new guidelines.
Register today!


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

Continuing Education


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 

Short Course or Primer

To keep you at the forefront.

Jan 27, 2019

Short Course 1:

Introduction to Pharmacoepidemiology

Jan 27, 2019

Short Course 2:

Pharmacovigilance and Risk Management Planning

Jan 27, 2019

Short Course 3:

Reference Safety Information

Jan 27, 2019

Short Course 4:

Combination Therapies

Program Committee

  • Stella  Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP
    Stella Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP Strategy
    Consultant, United Kingdom
  • William  Gregory, PhD
    William Gregory, PhD Senior Director, Safety and Risk Management
    Pfizer Inc, United States
  • Mariette  Boerstoel-Streefland, MD, MBA, MS
    Mariette Boerstoel-Streefland, MD, MBA, MS Senior Vice President, Worldwide Safety Officer
    Bristol-Myers Squibb Company, 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 Director of Delivery
    Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
  • E. Stewart  Geary, MD
    E. Stewart Geary, MD Senior Vice President
    Eisai Co., Ltd., Japan
  • Lisa Melanie Harinstein, PharmD
    Lisa Melanie Harinstein, PharmD Team Leader, Division of Pharmacovigilance, FDA
    FDA, United States
  • Stephen  Knowles, MD, MRCP
    Stephen Knowles, MD, MRCP Chief Medical Officer
    Halozyme Therapeutics, United States
  • Barbara  Morollo, RN
    Barbara Morollo, RN Head, Pharmacovigilance
    Corbus Pharmaceuticals, United States
  • Robert  Pratt
    Robert Pratt Risk Management Analyst
    FDA, United States
  • Michael  Richardson, MD, FFPM, FRCP
    Michael Richardson, MD, FFPM, FRCP Senior Vice President, WorldWide Patient Safety
    Bristol-Myers Squibb, United Kingdom
  • Annette  Stemhagen, DrPH, PhD, FISPE
    Annette Stemhagen, DrPH, PhD, FISPE Chief Science Officer
    UBC, United States

Digital Learning Catalog

DIA Learning: eLearning Soultions

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