Workshop on measuring the impact of pharmacovigilance activities

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TitleWorkshop on measuring the impact of pharmacovigilance activities
Date05/12/2016 - 06/12/2016
LocationEuropean Medicines Agency, London, UK
SummaryIn January 2016 the Pharmacovigilance Risk Assessment Committee (PRAC) adopted a strategy for measuring the impact of pharmacovigilance activities performed at European Union (EU) and Member States level which relies on a collaborative approach of all stakeholders. Measuring the impact of key pharmacovigilance activities will allow regulators and stakeholders to determine which activities are most successful and to identify enablers and barriers for generating positive health impacts which will contribute to the further development of proactive pharmacovigilance systems and to promote best practice across the EU. The aim of this workshop is to facilitate the implementation of the PRAC strategy with a particular focus on the development of methodologies and the fostering of collaboration.

All documents

Name Language First published Last updated
Report - Workshop on measuring the impact of pharmacovigilance activities (English only) 2017-03-27  
Call for expressions of interest - Workshop on measuring the impact of pharmacovigilance activities (English only) 2016-04-04  
Programme - Workshop on measuring the impact of pharmacovigilance activities (English only) 2016-08-04 2016-11-25
List of participants - Workshop on measuring the impact of pharmacovigilance activities (English only) 2016-12-20  
Presentation - Why measuring the impact of regulatory actions? (June Raine) (English only) 2016-12-20  
Presentation - Regulatory initiatives for measuring the impact of pharmacovigilance (Dolores Montero) (English only) 2016-12-20  
Presentation - The PRAC strategy for measuring impact of pharmacovigilance activities (Thomas Goedecke) (English only) 2016-12-20  
Presentation - PMDA experience with measuring the impact of pharmacovigilance (Shinobu Uzu) (English only) 2016-12-20  
Presentation - Health Canada experience with measuring the impact of pharmacovigilance (John Patrick Stewart) (English only) 2016-12-20  
Presentation - How is industry approaching the impact of pharmacovigilance activities (Robert Reynolds) (English only) 2016-12-20  
Presentation - Challenges and opportunities to measuring the impact of regulatory actions (Sabine Straus) (English only) 2016-12-20  
Presentation - Defining engagement - awareness and perception of public health measures (Patrick Brown) (English only) 2016-12-20  
Presentation - ISPE paper 'Evaluating the effectiveness of additional risk minimisation measures via surveys in Europe: Challenges and recommendations (Rachel Sobel, Terry Madison) (English only) 2016-12-20  
Presentation - Patient reporting in EudraVigilance - a measure of patient engagement? (Marin Banovac) (English only) 2016-12-20  
Presentation - Methods to go from process outcomes to health outcomes (Stephen Evans) (English only) 2016-12-20  
Presentation - Study of liver function monitoring in patients receiving agomelatine in the EHI database (Maia Uuskula) (English only) 2016-12-20  
Presentation - Modelling methods to estimate the public health impact of regulatory decisions (Saad Shakir) (English only) 2016-12-20  
Presentation - Challenges of measuring impact of new pharmacovigilance processes (Judith Sanabria) (English only) 2016-12-20  
Presentation - Measuring impact: a review of survey studies to evaluate the effectiveness of additional risk minimisation measures in Europe (Nawab Qizilbash) (English only) 2016-12-20  
Presentation - Measuring time from identification of a new risk to regulatory action with focus on signalling tools and processes (Amie Goulbourne) (English only) 2016-12-20  
Presentation - The risk of asthma therapy as assessed from real-life data ASTRO-LAB & SNIIRAM (Eric van Ganse) (English only) 2016-12-20  
Presentation - Report on enablers and barriers to measuring impact - patient and healthcare professional engagement (Martin Huber) (English only) 2016-12-20  
Presentation - Report on 'from regulatory outputs to health outcomes' (Daniel Morales) (English only) 2016-12-20  
Presentation - Report on measures of impact of pharmacovigilance processes (Marieke De Bruin) (English only) 2016-12-20  
Presentation - How researchers contribute to measuring impact? (Agnes Kant) (English only) 2016-12-20  
Presentation - How can patients and caregivers contribute to generate data on behavioural changes? (Elisa Ferrer) (English only) 2016-12-20  
Presentation - How can healthcare professionals contribute to generate data on behavioural changes? (Jamie Wilkinson) (English only) 2016-12-20  
Presentation - How can pharmaceutical industry contribute to measuring impact? (David Lewis on behalf of Vicky Edwards) (English only) 2016-12-20  
Presentation - Pharmacovigilance system impact - EU regulatory network collaboration and initiaves (Xavier Kurz on behalf of Julie Williams) (English only) 2016-12-20  
Presentation - FDA experience with measuring the impact of pharmacovigilance (Gerald Dal Pan) (English only) 2016-12-20  

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Registration

  • Registration closed.
  • Places limited.

Live broadcast

  • 05 December 2016
    13:00 - 17:20 UK time
  • 06 December 2016
    13:00 - 17:00 UK time

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