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 DetectionSince 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.
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Short Course or Primer
To keep you at the forefront.
Program Committee
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Stella Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP Strategy
Consultant, United Kingdom -
William Gregory, PhD Senior Director, Safety and Risk Management
Pfizer Inc, United States -
Mariette Boerstoel-Streefland, MD, MBA, MS Senior Vice President, Worldwide Safety Officer
Bristol-Myers Squibb Company, United States -
Cheryl Campbell, MS Associate Director of Executive Operations/Outreach and Communications, OSE,CDER
FDA, United States -
Mick Foy Deputy Director of Patient Safety Monitoring
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom -
E. Stewart Geary, MD Senior Vice President
Eisai Co., Ltd., Japan -
Lisa Melanie Harinstein, PharmD Team Leader, Division of Pharmacovigilance, FDA
FDA, United States -
Stephen Knowles, MD, MRCP Chief Medical Officer
Halozyme Therapeutics, United States -
Barbara Morollo, RN Head, Pharmacovigilance
Corbus Pharmaceuticals, United States -
Robert Pratt Risk Management Analyst
FDA, United States -
Michael Richardson, MD, FFPM, FRCP Senior Vice President, WorldWide Patient Safety
Bristol-Myers Squibb, United Kingdom -
Annette Stemhagen, DrPH, PhD, FISPE Chief Science Officer
UBC, United States
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