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 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.
While we work on the agenda for 2019, check out our Program from 2018.
On-Demand Complimentary WebinarEncore 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.
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
- 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
Stella Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP • Vice President, Global Head of Early Access and Risk Management
IQVIA, United Kingdom
William Gregory, PhD • Safety and Risk Management
Pfizer Inc, United States
Mariette Boerstoel-Streefland, MD • Senior Vice President, Head Global Drug Safety
Shire, United States
Cheryl Campbell, MS • Associate Director of Executive Operations/Outreach and Communications, OSE,CDER
FDA, United States
Mick Foy • Head of Pharmacovigilance Strategy, 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 • Team Leader, Division of Pharmacovigilance I, OSE, CDER
FDA, United States
Stephen Knowles, MD, MRCP • Vice President, Drug Safety and Pharmacovigilance
Halozyme Therapeutics, United States
Barbara Morollo • Head, Pharmacovigilance Operations
Moderna Therapeutics, United States
Robert G Pratt •
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 & Risk Management
United BioSource Corporation, United States
Lesley Wise, PhD, MSc • Managing Director
Wise Pharmacovigilance and Risk Management Ltd, United Kingdom