Workshop on measuring the impact of pharmacovigilance activities
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.
-
List item
Report - Workshop on measuring the impact of pharmacovigilance activities (PDF/353.84 KB)
First published: 27/03/2017
Last updated: 27/03/2017
EMA/59474/2017 -
List item
Call for expressions of interest - Workshop on measuring the impact of pharmacovigilance activities (PDF/153.02 KB)
First published: 04/04/2016
Last updated: 04/04/2016
EMA/95397/2016 -
List item
Programme - Workshop on measuring the impact of pharmacovigilance activities (PDF/194.57 KB)
Adopted
First published: 04/08/2016
Last updated: 25/11/2016
EMA/512056/2016 -
List item
List of participants - Workshop on measuring the impact of pharmacovigilance activities (PDF/172.44 KB)
First published: 20/12/2016
Last updated: 20/12/2016
EMA/757893/2016 -
List item
Presentation - Why measuring the impact of regulatory actions? (June Raine) (PDF/3.34 MB)
First published: 20/12/2016
Last updated: 20/12/2016 -
List item
Presentation - Regulatory initiatives for measuring the impact of pharmacovigilance (Dolores Montero) (PDF/1.2 MB)
First published: 20/12/2016
Last updated: 20/12/2016 -
List item
Presentation - The PRAC strategy for measuring impact of pharmacovigilance activities (Thomas Goedecke) (PDF/1.04 MB)
First published: 20/12/2016
Last updated: 20/12/2016 -
List item
Presentation - PMDA experience with measuring the impact of pharmacovigilance (Shinobu Uzu) (PDF/1.46 MB)
First published: 20/12/2016
Last updated: 20/12/2016 -
List item
Presentation - Health Canada experience with measuring the impact of pharmacovigilance (John Patrick Stewart) (PDF/860.88 KB)
First published: 20/12/2016
Last updated: 20/12/2016 -
List item
Presentation - How is industry approaching the impact of pharmacovigilance activities (Robert Reynolds) (PDF/1.88 MB)
First published: 20/12/2016
Last updated: 20/12/2016 -
List item
Presentation - Challenges and opportunities to measuring the impact of regulatory actions (Sabine Straus) (PDF/6.14 MB)
First published: 20/12/2016
Last updated: 20/12/2016 -
List item
Presentation - Defining engagement - awareness and perception of public health measures (Patrick Brown) (PDF/968.71 KB)
First published: 20/12/2016
Last updated: 20/12/2016 -
List item
Presentation - ISPE paper 'Evaluating the effectiveness of additional risk minimisation measures via surveys in Europe: Challenges and recommendations (Rachel Sobel, Terry Madison) (PDF/360.45 KB)
First published: 20/12/2016
Last updated: 20/12/2016 -
List item
Presentation - Patient reporting in EudraVigilance - a measure of patient engagement? (Marin Banovac) (PDF/777.32 KB)
First published: 20/12/2016
Last updated: 20/12/2016 -
List item
Presentation - Methods to go from process outcomes to health outcomes (Stephen Evans) (PDF/709.16 KB)
First published: 20/12/2016
Last updated: 20/12/2016 -
List item
Presentation - Study of liver function monitoring in patients receiving agomelatine in the EHI database (Maia Uuskula) (PDF/174.02 KB)
First published: 20/12/2016
Last updated: 20/12/2016 -
List item
Presentation - Modelling methods to estimate the public health impact of regulatory decisions (Saad Shakir) (PDF/1.19 MB)
First published: 20/12/2016
Last updated: 20/12/2016 -
List item
Presentation - Challenges of measuring impact of new pharmacovigilance processes (Judith Sanabria) (PDF/550.36 KB)
First published: 20/12/2016
Last updated: 20/12/2016 -
List item
Presentation - Measuring impact: a review of survey studies to evaluate the effectiveness of additional risk minimisation measures in Europe (Nawab Qizilbash) (PDF/394.45 KB)
First published: 20/12/2016
Last updated: 20/12/2016 -
List item
Presentation - Measuring time from identification of a new risk to regulatory action with focus on signalling tools and processes (Amie Goulbourne) (PDF/682.79 KB)
First published: 20/12/2016
Last updated: 20/12/2016 -
List item
Presentation - The risk of asthma therapy as assessed from real-life data ASTRO-LAB & SNIIRAM (Eric van Ganse) (PDF/231.37 KB)
First published: 20/12/2016
Last updated: 20/12/2016 -
List item
Presentation - Report on enablers and barriers to measuring impact - patient and healthcare professional engagement (Martin Huber) (PDF/82.58 KB)
First published: 20/12/2016
Last updated: 20/12/2016 -
List item
Presentation - Report on 'from regulatory outputs to health outcomes' (Daniel Morales) (PDF/75.86 KB)
First published: 20/12/2016
Last updated: 20/12/2016 -
List item
Presentation - Report on measures of impact of pharmacovigilance processes (Marieke De Bruin) (PDF/97.79 KB)
First published: 20/12/2016
Last updated: 20/12/2016 -
List item
Presentation - How researchers contribute to measuring impact? (Agnes Kant) (PDF/492.24 KB)
First published: 20/12/2016
Last updated: 20/12/2016 -
List item
Presentation - How can patients and caregivers contribute to generate data on behavioural changes? (Elisa Ferrer) (PDF/632.51 KB)
First published: 20/12/2016
Last updated: 20/12/2016 -
List item
Presentation - How can healthcare professionals contribute to generate data on behavioural changes? (Jamie Wilkinson) (PDF/692.15 KB)
First published: 20/12/2016
Last updated: 20/12/2016 -
List item
Presentation - How can pharmaceutical industry contribute to measuring impact? (David Lewis on behalf of Vicky Edwards) (PDF/378.76 KB)
First published: 20/12/2016
Last updated: 20/12/2016 -
List item
Presentation - Pharmacovigilance system impact - EU regulatory network collaboration and initiaves (Xavier Kurz on behalf of Julie Williams) (PDF/543.7 KB)
First published: 20/12/2016
Last updated: 20/12/2016 -
List item
Presentation - FDA experience with measuring the impact of pharmacovigilance (Gerald Dal Pan) (PDF/1.12 MB)
First published: 20/12/2016
Last updated: 20/12/2016