概要

Tutorials: January 24*
Tutorial #1 – Pharmacovigilance and Risk Management Planning
Tutorial #2 – FDA Adverse Event Reporting System (FAERS): Individual Case Safety Reports (ICSR) and Data Quality
Tutorial #3 – Periodic Benefit-Risk Evaluation Report (PBRER)
Tutorial #4 – Principles and Practice of Pharmacovigilance Governance
*Tutorials require registration and are an additional fee

Conference Dates: January 25-27

The health care delivery system continues to evolve to provide ever-enhanced value to patients. This requires a shift in regulatory science, tools, realities, and perceptions of biopharmaceutical product benefit-risk across the global pharmacovigilance landscape. It is more important than ever to find ways to fully harness innovation and adopt new technologies to advance pharmacovigilance practices. During this three-day meeting, thought leaders from around the world will provide their insights and engage in dialogue on current and potential new opportunities, operational challenges, and practical aspects, as well as demands in managing product risk in the context of benefits, in the ever-changing world of medical product safety, pharmacovigilance, and global regulations.

This event will provide an unique opportunity for dialogue with representatives from FDA and other key regulatory agencies, as well as from industry and academia. There will be multiple opportunities for participants to engage with speakers and interact with colleagues.

Conference Highlights:

Global Regulatory Safety Updates
New Data Sources for Safety Assessment
Current Approaches to Benefit-Risk Assessment
Luncheon Roundtable Discussions with Key Thought Leaders
Tabletop Exhibits and Networking Opportunities
Tutorial Offerings on Sunday, January 24

Experience the Conference on the Go with the DIA Global App

Once you’re registered, use the DIA Global app to start preparing for the conference! Download the app to view the agenda and speakers, network with attendees and exhibitors, and get updates throughout the conference. Available for all Apple and Android products – just search “DIA Global” in your app store.

SAVE THE DATE

Pharmacovigilance and Risk Management Strategies 2017
Tutorials: January 22, 2017
Conference: January 23-25, 2017
Location: Mandarin Oriental, Washington DC

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Want to learn more about Pharmacovigilance and Risk Management Strategies 2016? You've come to the right site!

参加対象

Intermediate to Advanced Clinical Safety Professionals who are involved in:

Drug Safety/Pharmacovigilance
Risk Management, including Risk Evaluation and Mitigation Strategies (REMS)
Medical Product Safety Assessment
Regulatory Affairs
Clinical Research
Pharmacoepidemiology
Customer Engagement Programs, including Patient Support Programs
Medical Information
Health Outcomes

It is also designed for professionals who work for:

Industry: Pharmaceuticals and Biologics
Clinical Research Organizations (CROs)
Academic Research Centers
Regulatory Agencies

学習目的

At the conclusion of this conference, participants should be able to:

Employ the current regulatory framework for pharmacovigilance in key markets
Utilize various aspects of Customer Engagement Programs, such as patient support programs (PSPs) for collection and management of safety data
Discuss how advanced therapies and new approaches may impact pharmacovigilance and risk management
Describe how new data sources and new technologies effect safety data management
Examine new trends and approaches for the safety assessment of biosimilars

Short Course or Primer

To keep you at the forefront.

2016年1月24日 (日)

Tutorial #1 - Pharmacovigilance and Risk Management Planning:

2016年1月27日 (水)

Tutorial #2 – FDA Adverse Event Reporting System (FAERS):

Individual Case Safety Reports (ICSR) and Data Quality

2016年1月26日 (火)

Tutorial #3 – Periodic Benefit-Risk Evaluation Report (PBRER):

2016年1月26日 (火)

Tutorial #4 – Principles and Practice of Pharmacovigilance Governance:

2016年1月24日 (日)

Tutorial #1 - Pharmacovigilance and Risk Management Planning:

2016年1月27日 (水)

Tutorial #2 – FDA Adverse Event Reporting System (FAERS):

Individual Case Safety Reports (ICSR) and Data Quality

2016年1月26日 (火)

Tutorial #3 – Periodic Benefit-Risk Evaluation Report (PBRER):

2016年1月26日 (火)

Tutorial #4 – Principles and Practice of Pharmacovigilance Governance:

プログラム委員会

William Gregory, PHD Senior Director, Safety and Risk Management
Pfizer Inc, United States
Stella Blackburn, MD, MA, MSC, FFPM, FISPE, FRCP Strategy
Consultant, United Kingdom
Mariette Boerstoel-Streefland, MD, MBA, MS Senior Vice President, Patient Safety Officer
Bristol Myers Squibb, United States
JP Clement, MD Founder and Principal
JPCC Associates, United States
E. Stewart Geary, MD MD, Global Safety Officer
Eisai Co., Ltd., Japan
Dipti Kalra, MBA, MS, RPH Team Leader, Office of Scientific Investigations, OC, CDER
FDA, United States
Stephen Knowles, MD, MRCP Chief Medical Officer
Halozyme Therapeutics, United States
Robert L. Levin, MD Lead Medical Officer for Pharmacovigilance Strategy
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
Cheryl Campbell, MS Associate Director of Executive Operations/Outreach and Communications, OSE,CDER
FDA, United States