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.
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.
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 healthcare delivery system in the US and EU.
- 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
- Introduction to Drug Safety (eLearning, Anytime, Anywhere)
- Drug Safety Regulatory Requirements (eLearning, Anytime, Anywhere)
- Premarketing Clinical Trial Safety (eLearning, Anytime, Anywhere)
- Postmarketing Safety Management (eLearning, Anytime, Anywhere)
- Basics of Signal Detection and Pharmacoepidemiology (eLearning, Anytime, Anywhere)
- Safety Audits and Inspections (eLearning, Anytime, Anywhere)
- Clinical Safety and Pharmacovigilance Certificate Program
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
- 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
At the conclusion of this conference, participants should be able to:
- Apply 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 approaches to pharmacovigilance and risk management, such as Artificial Intelligence/Machine Learning
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 • Head of Pharmacovigilance Strategy
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
Simone Pinheiro, PhD • Lead Epidemiologist
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
Lesley Wise, PhD, MSc • Managing Director
Wise Pharmacovigilance and Risk Management Ltd, United Kingdom
On-Demand Complimantary Webinar
Preconference Short Course Options
Pharmacovigilance and Risk Management Planning
Pharmacovigilance Inspections Part 1: Readiness, Conducting, Findings, and Report-Outs
Pharmacovigilance Inspections Part 2: Response, Measurement, Resolution, and Tracking