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Session 4 QPPVs and RMMs evaluation studies. What is out there?
Session Chair(s)
Susana Perez-Gutthann, MD, PhD, MPH, FISPE, FRCP
Vice President, Global Head Epidemiology
RTI Health Solutions, Spain
Winrich Rauschning, DrMed, MD, MBA
QPPV
Biolitec Pharma, Germany
Ten years have passed since the development of the Model of Excellence in pharmacovigilance, and three years since the EMA Guideline on good pharmacovigilance practice was published. The number of post-approval safety studies (PASS) has increased dramatically specially those focused on the evaluation of the effectiveness of risk minimization measures, all of which need to be reviewed by EU QPPVs. These studies can be extremely complex to conduct, have less history in implementation and methodology that other types of PASS, and their value needs to be assessed. The goal of the session is to provide an overview of the expectations, state of the art knowledge and experience and lessons learned from a regulatory, research and industry perspective with a focus on the needs of EU QPPVs and their teams. Regulatory expectations, key concepts on designs and methods, data collection and available data sources will be reviewed. The session will include opportunity for questions and answers.
Speaker(s)
How We Got Here and What Does the Future Hold? A Regulatory Perspective
June Raine, MD, MSc, FRCP
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Chief Executive
Making It Happen (I): Study Types and Data Sources. A Research Centre Perspective
Susana Perez-Gutthann, MD, PhD, MPH, FISPE, FRCP
RTI Health Solutions, Spain
Vice President, Global Head Epidemiology
Making It Happen (II): Challenges and Opportunities. Where Is the Role of the QPPV? An Industry Perspective
Lesley Wise, PhD, MSc
Wise Pharmacovigilance and Risk Management, Ltd, United Kingdom
Managing Director
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