OPP Meeting Summary: EP JURI Committee – Exchange of views with Commissioner Reynders and Commissioner Breton (20 February 2020)

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Agenda: Medical Devices Coordination Group – Subgroup Unique Device Identification (UDI) (17 February 2020)

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Press Release: Capacity building of the European Reference Networks to develop and adapt clinical decision-making tools addressing rare diseases: the ERN-Clinical Guidelines Programme

In a meeting held in Brussels last 6th February, the Commission introduced a new project to provide technical assistance to the ERNs for the development, appraisal and implementation of Clinical Practice Guidelines (CPGs) and Clinical Decision Support Tools (CDSTs). This 4 years contract will enable the ERNs to adopt a common methodology and develop their own decision-making tools: 48 new CPGs are expected and 120 existing CPGs will be adapted to the specific rare diseases they are addressing.

JRC Publication: Overview of the blood compatibility of nanomedicines: A trend analysis of in vitro and in vivo studies

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OPP Meeting Summary: Health Council – COVID-19 outbreak (13 February 2020)

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Preparation of the Employment, Social Policy, Health and Consumer Affairs Council session on 13 February 2020: Novel Coronavirus (2019-nCoV)

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Stakeholder Publication: Fair competition for SMEs – Letter to DG SANTE

By European Confederation of Pharmaceutical Entrepreneurs

Following the application of the new organisation of the European Commission’s DG SANTE, EUCOPE took the opportunity to send a letter to Ms Anna-Eva Ampelas, recently appointed as Head of Unit B6 on Medical Devices, to outline our concerns on the implementation status of the Medical Devices Regulation (MDR – 2017/745) and In Vitro Diagnostics Regulation (IVDR – 2017/746). The document stressed the importance to ensure a level-playing field for small and medium-sized companies when both texts will come into practice.

Stakeholder Press Release: Call for a Mutual Recognition Agreement on Good Manufacturing Practice (GMP) in the Context of Ambitious and Comprehensive EU-UK Future Relationship Negotiations

By European Federation of Pharmaceutical Industries and Associations

The pharmaceutical industry in Europe has worked to support the EU27 and UK to reach an agreement that will allow patients to receive medicines and medical technologies without disruption and provide long term co-operation between the EU and the UK in areas such as research, clinical trials, pharmacovigilance and access to talent. Our industry’s stance remains that the EU and UK should have the closest possible relationship for pharmaceuticals, prioritising the health of citizens and the uninterrupted supply of medicines.

UPDATED – Call for application for the selection of observers to the Annex XVI sub-group of the Medical Device Coordination Group

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Agenda: Working Party on Pharmaceuticals and Medical Devices (18 February 2020)

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Press Release: Advocate General Bobek: The civil liability insurance of breast implant producer PIP could validly be limited to women who underwent surgery in France

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Press Release: EIB backs EUR 4.9 billion clean energy, sustainable transport, agriculture and housing investment

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UPDATED – Agenda: EMA Committee for medicinal products for human use (CHMP) (27 – 30 January 2020)

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Commission Implementing Decision of 28.1.2020 concerning the 2020 work programme in the framework of the third programme of Union action in the field of health (2014-2020) and the EU’s financial contribution to the WHO Framework Convention on Tobacco Control

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OPP Meeting Summary: EP ENVI Committee – Exchange of views with Mr Milan Kujundžić, Croatian Minister of Health (20 January 2020)

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Written Answer to a Question: Regulation (EU) 2017/745 on medical devices and the shortage of notified bodies in 2020

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Agenda: Working Party on Pharmaceuticals and Medical Devices (29 January 2020)

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OPP Meeting Summary: EP Plenary: Oral question – 3D-printed illicit objects (16 January 2020)

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Press Release: Public procurement of innovative implantable pacemakers started

The RITMOCORE consortium – four hospitals and hospital foundations in Spain and the UK – invites interested bidders to submit offers to their public procurement of innovative solutions (PPI). This PPI aims to deploy innovative service provisioning of implantable pacemakers. Deadline for submitting offers is 16 March 2020.

UPDATED – Agenda: EP ENVI Committee Meeting (2 & 3 December 2019)

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Decentralised Procedure – Requests to act as RMS

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Guidance on Cybersecurity for medical devices

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Event: Cancer & Immunotherapy – FEAM Forum annual lecture 2020 (Brussels, 20 March 2020)

The FEAM European Biomedical Policy Forum – with the support of Cancer Research UK – is delighted to welcome you to the next annual lecture 2020 on ‘Cancer & Immunotherapy: greatest challenges and novel therapies inspiring European citizens’.

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