European Medicines Agency Slideshows

 

Protocol Assistance: Mini-COMP exercise

An exercise on the Committee for Orphan Medicinal Products (COMP) from part 1 of the protocol assistance session at the 2017 Summer School.

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Protocol Assistance: Mini-SAWP exercise

An exercise on the Scientific Advice Working Party (SAWP) from part 1 of the protocol assistance session at the 2017 Summer School.

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Protocol Assistance: Participating in Scientific Advice/Protocol Assistance

A presentation on participating in scientific advice and protocol assistance procedures, from part 2 of the protocol assistance session at the 2017 Summer School.

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PRIME Initiative

Presentation on how the EMA is working to foster the development of medicines with major public health interest.

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Declarations of Interest (DoI)

Slides on ensuring the transparency of expert patient contributions in interactions with regulators. EMA policy on the handling of competing interests.

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Introduction to the European Medicines’ Agency & Public Engagement framework

A slideshow by Nathalie Bere on the role of the EMA: how they improve access to medicines within the EU and the importance of patients’ input to the agency.

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A General Introduction to the European Medicines Agency (EMA)

A slideshow presentation on the role of the EMA: how they improve access to medicines within the EU and the importance of patients’ input to the agency.

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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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Patient Interaction with the EMA

A slideshow presentation on how the EMA reviews patient feedback on medicinal products.

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The Committee for Medicinal Products for Human Use (CHMP)

A slideshow presentation on the scientific committee responsible for delivering opinions on medicinal products for health care professionals and patients.

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The Role of Patient Organisations in Pharmaceuticals

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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The Committee for Orphan Medicinal Products (COMP)

A slideshow presentation on the procedure and criteria for a drug to become designated as an orphan drug and how this changes finances, marketing, and the public view.

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The Committee for Advanced Therapies (CAT)

A slideshow presentation on the Committee for Advanced Therapies’ role in regulating advanced therapy medicinal products (ATMP) within the EMA and how patients and healthcare professionals can get involved.

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The Paediatric Committee (PDCO)

A slideshow presentation on the Paediatric Committee and its involvement with regulating paediatric medicine and paediatric clinical trials within the EMA.

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Patient Involvement at the EMA

A slideshow presentation on how patients can voice their opinions to the EMA through the Patients’ and Consumers’ Working Party (PCWP).

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