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Wednesday, June 29 • 2:00pm - 3:15pm
#349: Measuring the Effectiveness of Risk Minimization: Principles and Regional Requirements

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Limited Capacity seats available
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-601-L04-P; CME 1.25; IACET 1.25; RN 1.25

Measuring effectiveness of risk minimization activities is an essential part of risk management, but doing it can be challenging. Experts will discuss requirements in different regions, CIOMS IX, possible methodologies, and the challenges.

Learning Objectives

Describe the importance of measuring the effectiveness of risk minimization activities and the requirements in different regions; Discuss the different methodologies for measuring effectiveness; Discuss opinions from regulatory, industry, and contract research on the challenges of measuring effectiveness.

Chair

Stella C.F. Blackburn

Speaker

Risk Management Plans and Risk Minimization: What Have We Learned and Where Is It All Going?
Shelley Gandhi, MS

CIOMS IX and the Theory of Assessing Effectiveness
Stella C.F. Blackburn

Additional Risk Minimization Measures for EU Centrally Authorized Products, 2006-2014: A Qualitative and Quantitative Review
Annalisa Rubino, PhD


Chair
avatar for Stella Blackburn

Stella Blackburn

Vice President, Global Head of Early Access & Risk Management, RWI, QuintilesIMS
Dr Stella Blackburn is currently VP, Global Head of Early Access & Risk Management at QuintilesIMS. She joined QI in April 2014 after more than 25 years working in PhV and pharmacoepi in industry and the European Medicines Agency. Stella is a Fellow of the International Society of... Read More →

Speakers
avatar for Stella Blackburn

Stella Blackburn

Vice President, Global Head of Early Access & Risk Management, RWI, QuintilesIMS
Dr Stella Blackburn is currently VP, Global Head of Early Access & Risk Management at QuintilesIMS. She joined QI in April 2014 after more than 25 years working in PhV and pharmacoepi in industry and the European Medicines Agency. Stella is a Fellow of the International Society of... Read More →
avatar for Shelley Gandhi

Shelley Gandhi

Strategic Advisor, Pharmacovigilance and Drug Safety, NDA Group
Shelley Gandhi brings a wealth of experience in the pharmacovigilance arena after being with the MHRA (UK Regulatory Authority) for 19 years and 2 years with the NDA group working with industry. She has extensive knowledge of all European regulatory processes related to monitoring... Read More →
AR

Annalisa Rubino

Director of Risk Management Epidemiology, Oxon Epidemiology
Annalisa Rubino is Director of Risk Management Epidemiology with OXON Epidemiology. She is a Pharmacoepidemiologist with extensive research experience in drug development in academia and industry. She has worked in consultancy for the pharmaceutical industry in therapeutic risk management... Read More →

Wednesday June 29, 2016 2:00pm - 3:15pm
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 14: Clin Safety-PV, Session