Slide presentations on Benefit–Risk and Pharmacovigilance

This section contains slide presentations from the EURORDIS Summer School on patient involvement in benefit risk at the European Medicines Agency, how the Pharmaceutical Risk Assessment Committee evaluates medicinal products.

 

Panorama of actions patient organisations can take in pharmacovigilance

Pharmacovigilance as a close watch on the medicines we take.

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Reporting side effects on SCOPE

Slides on using SCOPE to report Side effects

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Engaging in your own NCA on pharmacovigilance Including Web Radr and Social Media

Slides on how to engage your own National Competent Authority on Pharmacovigilance.

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Marketing authorisation and patients input in B/R assessment: part 1

2017 slides from Patrick Salmon on MA and patient input in Benefit Risk.

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Marketing authorisation and patients input in B/R assessment: part 2

2017 slides from François Houÿez on MA and patient input in Benefit Risk.

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The Role of Patient Organisations in Pharmacovigilance

A slideshow presentation on how organisations like the Scientific Advice Working Party (SAWP) and Protocol Assistance (PA) help drugs get on the market.

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Patient involvement in benefit-risk at the EMA

A slideshow presentation on the risk-benefit assessment and how the policy works through questionnaires with the EMA

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Pharmacovigilance Risk Assessment Committee

A slideshow presentation on the EMA’s Pharmacovigilance Risk Assessment Committee.

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Benefit Risk Assessment

A presentation from Patrick Salmon about the importance of balance in benefit risk assessment

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