Pharmacovigilance and Risk Management Strategies Conference

January 21: Short Courses
January 22-24: Conference

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 Webinar

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.
• PBRER
• 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.

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 
    

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