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Overview

January 21: Short Courses
January 22-24: 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.

View the Preliminary Schedule At-A-Glance!



Complimentary Webinar

Encore Presentation of Exploring the Evolution of Signal Detection
December 1 | 12:00-1:15PM ET
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!

Preconference Short Courses on Sunday, January 21

  • Pharmacovigilance and Risk Management Planning
    • This preconfrence training will focus on basic aspects of the regulatory framework for pharmacovigilance in the context of risk management planning and on the practical aspects of managing biopharmaceutical product risks in the context of benefits and the health care delivery system in the US and EU.
  • PBRER
    • This short course will cover the background and expectations behind key sections of the guideline and will provide an in-depth interpretation from the perspective of the expert working group that developed the concept.
  • Pharmacovigilance Inspections Part 1: Readiness, Conducting, Findings, and Report-Outs
    • You will hear two FDA experts and an EU expert explain how to be inspection ready, the Inspector’s expectations, and common missteps that result in observations. In turn, learn perspectives from an industry veteran on what to do before and during an inspection.
  • Pharmacovigilance Inspections Part 2: Response, Measurement, Resolution, and Tracking
    • This short course will familiarize you with the principles and practical methods of planning and preparing an effective response to inspection observations, including: coordinated response preparation, assessment of underlying causes, development and implementation of corrective and preventive action plans (CAPAs), measurement, and tracking.


More Learning Opportunities in Drug Safety

DIA and Rutgers School of Health Related Professions Biopharma Educational Initiative (Rutgers-SHRP-BEI) have partnered to offer academic credit to learners completing the DIA Drug Safety eLearning Program in conjunction with Rutgers online companion course. Learn more.

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 
      

Learning objectives

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

  • Employ 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 technologies such as Artificial Intelligence, for its management

Program Committee

  • Stella C.F. Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP
    Stella C.F. Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP Vice President, Global Head of Early Access & Risk Management,
    QuintilesIMS, 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
  • Mick  Foy
    Mick Foy Group Manager, 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 Senior Director, Global Patient Safety, Medical and Benefit Risk Management
    Eli Lilly and Company, United States
  • Barbara A Morollo, RN
    Barbara A Morollo, RN Head, Pharmacovigilance Operations
    Moderna Therapeutics, United States
  • Simone  Pinheiro, PhD
    Simone Pinheiro, PhD Lead Epidemiologist
    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
    UBC, An Express Scripts Company, United States
  • Lesley  Wise, PhD, MSc
    Lesley Wise, PhD, MSc Managing Director
    Wise Pharmacovigilance and Risk Management Ltd, United Kingdom
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