Pharmacovigilance and Risk Management Strategies Conference

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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 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

Short Course 1: Introduction to Pharmacoepidemiology | 9:00AM-5:00PM
Short Course 2: Pharmacovigilance and Risk Management Planning | 9:00AM-5:00PM
Short Course 3: Reference Safety Information | 9:00AM-12:30PM
Short Course 4: Combination Therapies | 1:30-5:00PM

Highlights

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!

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 • Vice President, Global Head of Early Access and Risk Management
IQVIA, United Kingdom
William Gregory, PhD • Senior Director, Worldwide Medical and Safety
Pfizer Inc, United States
Mariette Boerstoel-Streefland, MD, MBA, MS • Senior Vice President, Global Drug Safety
Alexion, United States
Cheryl Campbell, MS • Associate Director of Executive Operations/Outreach and Communications, OSE,CDER
FDA, United States
Mick Foy • Group Manager, 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 • Safety Evaluator, Division of Pharmacovigilance-I, Office of Surveillance , CDER
FDA, United States
Stephen Knowles, MD, MRCP • President, Drug Safety, and Pharmacovigilance
Halozyme Therapeutics, United States
Barbara Morollo • Pharmacovigilance and Risk Management Consultant
United States
Robert Pratt • Risk Management Analyst
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, and Risk Management
UBC, United States