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Pharmacovigilance and Risk Management Strategies 2014

Tutorials: January 12, 2014
Conference: January 13-15, 2014
Washington, DC

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Current Complexities and Controversies in Pharmacovigilance, Signal, and Risk Management 

This global three-day annual conference provides new insights into the current issues and associated challenges impacting drug safety, focusing primarily on drug products and biologics, throughout all phases of development and marketed use. 


Top pharmaceutical, biotechnology, and regulatory thought leaders convene each January to discuss new and updated legislation in various ICH regions, current regulatory framework for pharmacovigilance in global regions, operational challenges of implementing global Benefit-risk analyses and risk management plans, the impact of social media, and the role of epidemiology in safety analysis.

Session Topics:

  • FDA Updates
  • EU Regulations – Regulatory Overview
  • Drug Safety in China
  • Harmonization
  • Benefit-Risk and Risk Management
  • Real World Evidence
  • Social Media
  • Patient Perspective

Pharmacovigilance and Risk Management Strategies 2014


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Contact Us at +1.215.442.6100You may register online or download a registration form. For registration questions, please contact CustomerService@DIAHome.org or at +1.888.257.6457.

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Pharmacovigilance and Risk Management Strategies 2014Insider Update

This edition of Insider Update provides insights from key industry thought leaders about what you can expect on the current issues and associated challenges impacting drug safety throughout all phases of development and marketed use.

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GO Tutorials

Tutorials: Sunday, January 12
Morning Tutorials: 8:30 AM-12:00 PM


Tutorial #1 – Pharmacovigilance and Risk Management Planning
Tutorial Instructors
William W. Gregory, PhD
Senior Director, Safety and Risk Management
Pfizer Inc.

EMA Representative Invited

This tutorial will focus on the practical aspects of managing biopharmaceutical product risks in the context of a product’s benefits.

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

  • Discuss similarities and differences in risk management planning in the three ICH regions
  • Describe the differences between important identified risks and important potential risks
  • Outline the basic structure and contents of an EU Risk Management Plan (in the context of a Risk Management System) and a Risk Evaluation and Mitigation Strategy (REMS)
  • Discuss primary tools for managing product risks, how the effectiveness of a selected tool is assessed, and triggers for modification or removal of a given intervention
Tutorial #2 – Introduction to Pharmacoepidemiology and Applications in Pre-Marketing and Post-Marketing Surveillance, Risk Management, And Value Demonstration
Tutorial Instructor
Annette Stemhagen, DrPH, FISPE
Senior VP, Safety, Epidemiology, Registries & Risk Management

United BioSource Corporation

This tutorial will provide an overview of basic epidemiology methods and study designs as they are applied in the pharmaceutical and biotech industries. Topics will include design and conduct of retrospective and prospective epidemiologic studies such as case-control studies and cohort studies, and the application of these designs for pre-marketing and postmarketing surveillance, risk management (risk assessment and risk mitigation), and demonstration of product value.

Learning Objectives:  At the conclusion of this tutorial, participants should be able to:
  • Define basic epidemiologic principles
  • Distinguish case-control and cohort study designs
  • Identify applications for epidemiology in pre- and postmarketing pharmaceutical product safety surveillance and risk management
  • Identify applications for use of epidemiologic studies in demonstrating product value
Target Audience: This is a basic-level tutorial for individuals who would like to gain a general understanding of the role of epidemiology in pre- and post-marketing surveillance, risk management, and value demonstration.

Afternoon Tutorials:  1:30-5:00 PM

Tutorial #3 – ICH E2C (R2); The Quantum Leap from PSURs to Benefit Risk Evaluation (PBRERs)

Tutorial Instructor
Valerie E. Simmons, MD, FFPM 
EU QPPV, Global Patient Safety
Eli Lilly and Company Limited, UK

The new ICH E2C (E2C) guideline on Periodic Benefit Risk Evaluation Reports (PBRERs) reached Step 4 in November 2012 and has already implemented in the EU under the new Pharmacovigilance legislation. Also accepted in the US, Japan and other countries, the PBRER may replace existing requirements for post marketing periodic reporting. This new report represents a significant change from the previous PSUR format and a quantum leap forward toward a document incorporating many new concepts including an integrated evaluation of both benefits and risks of a medicinal product. 

At the conclusion of this activity, participants should be able to:
  • Discuss the main principles defined in the ICH E2C (R2) guideline
  • Describe the structure and content of the new PBRER
  • Explain the regulatory authority expectations of the PBRER
  • Recognize some of the key implementation challenges and how they may be addressed
  • Discuss the practical aspects in the preparation of the PBRER
Tutorial #4 - Pharmacovigilance System Master File
Tutorial Instructor
Noha Kassem, PhD 
Senior Director of Quality in Global Patient Safety
Eli Lilly and Company, UK

As part of the new EU Pharmacovigilance Legislation (Regulation EU 1235/2010 and Directive 2010/84/EU) marketing-authorization holders are required to maintain a Pharmacovigilance System Master File (PSMF). The PSMF must be in place at the time of initial marketing authorization application, license renewal and available for inspections. The PSMF replaced the Detailed Description of the Pharmacovigilance System (DDPS). This tutorial will cover the requirements in the PSMF, the creation and maintenance as well as sharing a real experience focusing on some of challenges and how they can be addressed.

At the conclusion of this activity, participants should be able to:
  • Discuss how to prepare a PSMF to meet the requirements
  • Describe how to maintain a PSMF so that it can be available within seven days from request
  • Examine challenges and possible scenarios of how to address preparation and maintenance

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Group Discounts Available! Register 3 individuals from the same company and receive complimentary registration for a 4th!

Register Online or submit a registration form by fax to +1.215.442.6199.

Registration Questions? Contact CustomerService@DIAHome.org or at +1.888.257.6457.

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