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Overview

January 22: Short Courses
January 23-25: Conference

Full Day Courses (includes box lunch)
Course 1: Pharmacovigilance and Risk Management Planning
Course 2: ICH E2C (R2); The Quantum Leap from PSURs to Benefit Risk Evaluation (PBRERs): Background, Expectations, and Practicalities

Half Day Courses (does not include lunch)
Course 3: FDA Adverse Event Reporting System (FAERS)
Course 4: FDA Pharmacovigilance Inspection Readiness

*Short Courses require separate registration



Pharmacovigilance and risk management are key activities for ensuring that the right products get to patients at the right time with the right balance of benefits and risks. Optimizing benefit-risk is an important matter not just for regulators, but for all stakeholders, and planning for pharmacovigilance activities and appropriate evidence gathering must be done throughout the medicine life cycle. Against a backdrop of rapid therapeutic innovation, technologic advances, and widening choices of potential safety data sources and analytical methodologies, the pharmacovigilance and risk management of today demand ever smarter approaches. 

DIA's Pharmacovigilance and Risk Management Strategies Conference is the leading forum for exploring insights into new technologies and innovative methods and how they can be utilized for pharmacovigilance in the broadest sense. The 2017 program will focus on cutting edge innovation across the entire life cycle of biopharmaceutical products – new therapeutic approaches to diseases that change patients’ lives, enlightened evolution of regulatory science that speeds needed products to prescribers and patients, and, most importantly, engagement of patients in the product development and regulatory processes. This valuable forum brings together industry, academia, regulators, and patient representatives for thought provoking sessions and candid discussion of common challenges.


Highlights
  • Global Regulatory Safety Updates
  • The Future of Pharmacovigilance
  • Luncheon Round Table Discussions with Key Thought Leaders
  • Special Hot Topic Panels and Debates
  • 27 Exhibiting Companies - View the Digital Exhibitor Directory
  • Networking Opportunities
  • Short Course Offerings on Sunday, January 22

Who should attend?

Professionals involved in:

  • Drug Safety/Pharmacovigilance
  • Risk Management and REMS
  • Benefit-Risk Assessment and Communication
  • Medical Product Safety Assessment
  • Regulatory Affairs
  • Clinical Research
  • Pharmacoepidemiology
  • Postmarket Studies and Real-World Evidence Generation
  • Customer Engagement Programs
  • Medical Information and Medical Communications
  • Health Outcomes

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 EU
  • Examine the influence of recent regulatory developments and expectations in Japan, China, and Mexico on safety and pharmacovigilance practice
  • Discuss how advanced therapies and technologies may impact pharmacovigilance and risk management
  • Discuss how the needs for access to innovative medicines and for safety information can be balanced during the application of new adaptive development pathways
  • Describe considerations for appraising the value of data sources outside the spontaneous reporting system for safety and benefit-risk assessments
  • Utilize new approaches for presentation of benefit-risk data and communication of risk-benefit messages to health care providers, patients, and consumers

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 Risk Management
    Quintiles Inc., United Kingdom
  • William W. Gregory, PhD
    William W. Gregory, PhD Senior Director, Worldwide Safety and Regulatory
    Pfizer Inc, United States
  • Mariette  Boerstoel-Streefland, MD, MBA, MS
    Mariette Boerstoel-Streefland, MD, MBA, MS Senior Vice President, Head Global Drug Safety
    Shire, United States
  • E. Stewart  Geary, MD
    E. Stewart Geary, MD Senior VP, Chief Medical Officer, Director, Corporate Medical Affairs HQ
    Eisai Co., Ltd., Japan
  • Elizabeth E. Garrard, PharmD
    Elizabeth E. Garrard, PharmD Executive Vice President, Global Safety Operations
    Clinipace Worldwide, United States
  • Lisa Melanie Harinstein, PharmD
    Lisa Melanie Harinstein, PharmD Safety Evaluator, 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
  • Robert L. Levin, MD
    Robert L. Levin, MD Lead Medical Officer for Pharmacovigilance Strategy
    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 and Risk Management
    UBC, An Express Scripts Company, United States
  • Mick  Foy
    Mick Foy Group Manager, Vigilance Intelligence and Research Group
    Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
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