Workshop on measuring the impact of pharmacovigilance activities

• Date:
  Monday, 05 December 2016
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

In 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.

Documents

Report - Workshop on measuring the impact of pharmacovigilance activities

Reference Number: EMA/59474/2017

Call for expressions of interest - Workshop on measuring the impact of pharmacovigilance activities

Reference Number: EMA/95397/2016

Programme - Workshop on measuring the impact of pharmacovigilance activities

AdoptedReference Number: EMA/512056/2016

List of participants - Workshop on measuring the impact of pharmacovigilance activities

Reference Number: EMA/757893/2016

Presentation - Why measuring the impact of regulatory actions? (June Raine)

Presentation - Regulatory initiatives for measuring the impact of pharmacovigilance (Dolores Montero)

Presentation - The PRAC strategy for measuring impact of pharmacovigilance activities (Thomas Goedecke)

Presentation - PMDA experience with measuring the impact of pharmacovigilance (Shinobu Uzu)

Presentation - Health Canada experience with measuring the impact of pharmacovigilance (John Patrick Stewart)

Presentation - How is industry approaching the impact of pharmacovigilance activities (Robert Reynolds)

Presentation - Challenges and opportunities to measuring the impact of regulatory actions (Sabine Straus)

Presentation - Defining engagement - awareness and perception of public health measures (Patrick Brown)

Presentation - ISPE paper 'Evaluating the effectiveness of additional risk minimisation measures via surveys in Europe: Challenges and recommendations (Rachel Sobel, Terry Madison)

Presentation - Patient reporting in EudraVigilance - a measure of patient engagement? (Marin Banovac)

Presentation - Methods to go from process outcomes to health outcomes (Stephen Evans)

Presentation - Study of liver function monitoring in patients receiving agomelatine in the EHI database (Maia Uuskula)

Presentation - Modelling methods to estimate the public health impact of regulatory decisions (Saad Shakir)

Presentation - Challenges of measuring impact of new pharmacovigilance processes (Judith Sanabria)

Presentation - Measuring impact: a review of survey studies to evaluate the effectiveness of additional risk minimisation measures in Europe (Nawab Qizilbash)

Presentation - Measuring time from identification of a new risk to regulatory action with focus on signalling tools and processes (Amie Goulbourne)

Presentation - The risk of asthma therapy as assessed from real-life data ASTRO-LAB & SNIIRAM (Eric van Ganse)

Presentation - Report on enablers and barriers to measuring impact - patient and healthcare professional engagement (Martin Huber)

Presentation - Report on 'from regulatory outputs to health outcomes' (Daniel Morales)

Presentation - Report on measures of impact of pharmacovigilance processes (Marieke De Bruin)

Presentation - How researchers contribute to measuring impact? (Agnes Kant)

Presentation - How can patients and caregivers contribute to generate data on behavioural changes? (Elisa Ferrer)

Presentation - How can healthcare professionals contribute to generate data on behavioural changes? (Jamie Wilkinson)

Presentation - How can pharmaceutical industry contribute to measuring impact? (David Lewis on behalf of Vicky Edwards)

Presentation - Pharmacovigilance system impact - EU regulatory network collaboration and initiaves (Xavier Kurz on behalf of Julie Williams)

Presentation - FDA experience with measuring the impact of pharmacovigilance (Gerald Dal Pan)

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