Comitology Written Consultation: Standing Committee on medicinal products for human use

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UPDATED – Agenda: EMA Pharmacovigilance Risk Assessment Committee (PRAC) (11-14 June 2019)

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Press release: Regulators’ advice can make a difference for faster patient access to highly innovative therapies

Early dialogue and frequent interactions between medicine developers, regulators, health technology assessment bodies (HTAs) and patients can play a key role in delivering robust data needed to enable accelerated access of patients to highly innovative therapies that address unmet medical needs. The chair of EMA’s committee for advanced therapies (CAT), Martina Schussler-Lenz, the chair of EMA’s human medicines committee (CHMP), Harald Enzmann, and the head of EMA’s scientific advice office, Spiros Vamvakas describe these interactions through the example of the recent authorisation of Zynteglo (lentiglobin) in a perspective piece published in Clinical Pharmacology & Therapeutics.

Stakeholder Press Release: Marseille statement: Building bridges for solidarity in public health

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Event: POLITICO’s Health Care Summit 2019 (Amsterdam, 21-22 November 2019)

On November 21-22, a couple of month after the first-ever High-Level Meeting on Universal Health Coverage (UHC) is taking place during the UN General Assembly, POLITICO is bringing the Annual Health Care Summit to Amsterdam — a world-renowned life science innovation center and the new home of the European Medicines Agency — for what will be its fourth successful edition. We’ll gather the industry’s top minds together with key policymakers, scientists, business leaders and patient representatives to debate on the policy and cooperative innovations to better public health for the whole of society.

Agenda: EMA Paediatric Committee (PDCO) (12-15 November 2019)

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Merger Case: M.9461 ABBVIE / ALLERGAN

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UPDATED – Agenda: EMA Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) (28 – 30 January 2019)

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UPDATED – Agenda: EMA Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) (26 – 28 February 2019)

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UPDATED – Agenda: EMA Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) (26 – 28 March 2019)

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UPDATED – Agenda: EMA Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) (23 – 25 April 2019)

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UPDATED – Agenda: EMA Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) (27-29 May 2019)

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UPDATED – Agenda: EMA Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) (25-27 June 2019)

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UPDATED – Agenda: EMA Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) (23-26 July 2019)

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Agenda: EMA Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) (12 – 13 November 2019)

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Event: National Conference on fight with falsified medicinal products for human use – Pharmaceuticals: fighting falsified medicines (Warsaw, Poland, 26 November 2019)

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Stakeholder Survey: 2019 Medicines Shortages Survey

By the European Association of Hospital Pharmacists (EAHP)

The 2019 Medicines Shortages Survey seeks to investigate some of the reasons for medicines shortages in hospitals as well as the impact on patients. In addition, it will identify solutions in place as well as best practices currently applied at local, regional and national level.
The survey targets hospital pharmacists, nurses, physicians, other healthcare professionals working in the hospital environment and patients.

Event: Annual Patients and Consumers Working Party (PCWP) and Healthcare Professionals Working Party (HCPWP) meeting with all eligible organisations (Amsterdam, 20 November 2019)

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UPDATED – Event: European partnership for alternative approaches to animal testing annual conference 2019: Building confidence for the use of 3Rs (Brussels, 29 October 2019)

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CAT monthly report of application procedures, guidelines and related documents on advanced therapies

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UPDATED – Comitology Meeting: Standing Committee on Plants, Animals, Food and Feed – Section: “Phytopharmaceuticals – Legislation” (21-22 October 2019)

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UPDATED – Merger Case: M.9540 PERMIRA / CAMBREX

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Event: A multi-stakeholder approach to pharmaceuticals in the environment (Brussels, 12 November 2019)

On Tuesday, 12 November 2019, as part of the Safer Pharma programme, Health Care Without Harm (HCWH) Europe will host a one-day workshop in Brussels to look at a multi-stakeholder approach to pharmaceuticals in the environment. The event will bring together key participants from EU and international institutions, national governments, industry, civil society and academia.

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