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概览
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 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.
Register today!
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.
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项目委员会
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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 Director of Delivery
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom -
E. Stewart Geary, MD MD, Global Safety Officer
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 -
Simone P. Pinheiro, MSc Head, PharmacoEpidemiology Center of Excellence (PeCoE)
AbbVie, 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 -
Lesley Wise, PhD, MSc Managing Director
Wise Pharmacovigilance and Risk Management, Ltd, United Kingdom
