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Emer Cooke nominated as new EMA Executive Director

26 Jun 2020
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The EMA Management Board has nominated Emer Cooke as the new Executive Director of the Agency. At an extraordinary virtual session on 25 June, the Board selected Emer Cooke from a shortlist of candidates created by the European Commission. Ms Cooke will now be invited to give a statement to the European Parliament’s Committee on Environment, Public Health and Food Safety (ENVI) on 13 July 2020. The appointment of the new Executive Director will only be made after that meeting.

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Committee on Environment
quality
Safety
efficacy and performance

First COVID-19 treatment recommended for EU authorisation

26 Jun 2020
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EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation to Veklury (remdesivir) for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen. Remdesivir is the first medicine against COVID-19 to be recommended for authorisation in the EU. Data on remdesivir were assessed in an exceptionally short timeframe through a rolling review procedure, an approach used by EMA during public health emergencies to assess data as they become available.
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non-clinical data
COVID-19.
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Dr. Gustav Klein and MG2: the FAT between distance and reality

25 Jun 2020
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Three days to test a capsule filler for phytopharmaceutical and nutraceutical products: a success signed by Italy and Germany joint work! Read the ITALIAN version One of MG2 first goals consists in reaching the customer by providing the best technical solutions. This goal has become even more strategic during the present worldwide spring 2020 crisis, which severely limited the movement of both people and goods. MG2 has successfully overcome this difficulty thanks to remote working technical solutions, chosen among the most consolidated office automation tools.

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COVID-19 EMERGENCY

25 Jun 2020
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For this reason, it implemented all the indications provided for by the Shared Protocol on March 14, 2020 between the Government, Trade Unions and Trade Associations. In order to allow its employees and suppliers to access workplaces in compliance with the precautions that the current serious situation requires to adopt.

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Global regulators discuss data requirements for phase 3 trials of COVID-19 vaccines

25 Jun 2020
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Under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), international regulators discussed COVID-19 vaccine development and the necessary evidence required for regulatory decision-making at the second regulatory workshop on COVID-19 vaccines.
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Covid-19
diverse populations
primary endpoints

European regulators make recommendations drawing on lessons learnt from presence of nitrosamines in sartan medicines

24 Jun 2020
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The European medicines regulatory network has issued recommendations on impurities in medicines following the conclusion of an exercise to draw on lessons learnt from the presence of nitrosamines in a class of blood pressure medicines known as sartans. The recommendations aim to clarify the roles and responsibilities of companies involved in the manufacture of medicines and to amend guidance on controlling impurities and good manufacturing practice.
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swift regulatory action
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Academia developing medicines for rare diseases to receive free EMA scientific advice

24 Jun 2020
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The academic sector plays an important role in the development of innovative medicines. Their scientific research is often at the source of novel methodologies and innovative medicines with a potential to benefit patients with rare diseases. Early interaction with EU regulators is important for academia to understand the regulatory requirements and allow the generation of robust evidence needed to establish the medicines’ benefits and risks.
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METE PLASTİK HELPS FOR HEALTHCARE PROFESSIONALS BY PRODUCING FACE SHIELDS AGAINST COVID 19

23 Jun 2020
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We as METE PLASTIC INDUSTRY AND CO.INC. give most of the face shields that we produce to those healthcare professionals as a gift What we do is not enough for our healthcare professionals who present self sacrifice on these difficult days.

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Coronavirus: An update from the Meech team

23 Jun 2020
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The situation with the Coronavirus/COVID-19 is, as I’m sure you’re aware, constantly evolving. Our senior management team are meeting regularly to review the guidance we receive and the advice we give. We have also updated our procedures to ensure we are able to honour our commitments to our team and our customers. Our intention at this time is to maintain an uninterrupted supply chain, this will include functioning production, order processing and technical departments, along with a customer service support team.

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European Commission, EMA and FDA agree new priorities to strengthen their collaboration on medicines

23 Jun 2020
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The collaboration between EMA and FDA formally started in 2003 and the two agencies have now almost daily interactions, most of them structured around working groups called 'clusters', some of which include contacts with other international regulators, with the aim to better align, and advance scientific and regulatory excellence worldwide. In the context of the COVID-19 pandemic, the EC, EMA and FDA have further intensified their collaboration through regular interactions, notably under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA).

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