• Emer Cooke nominated as new EMA Executive Director

    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.

  • First COVID-19 treatment recommended for EU authorisation

    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.
  • Dr. Gustav Klein and MG2: the FAT between distance and reality

    News: 

    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. Indeed, with Microsoft Teams, the video conferencing and Office 365 package remote working tool, MG2 can offer technical assistance, commercial support and advanced solutions, by using a familiar tool applicable to any business context. With this technology MG2 successfully carried out the first remote testing. This is the case of the Factory Acceptance Test run with the customer Dr. Gustav Klein GmbH & Co. KG, a company of the Alpen Pharma Group, that is specialized in the production and distribution of herbal medicinal and homeopathic products based on traditional knowledge with benefit of state-of-the-art technologies and equipment. Exporting to over 20 countries worldwide, the company works closely with national and international pharmaceutical companies as valuable contract manufacturer. Dr. Gustav Klein offers the best solutions thanks to the partnership with leading market suppliers of technical equipment that share their values ​​of sustainability, trust and tradition such as MG2. The machine at the centre of the remote FAT and the partnership with MG2 is an MG Compact capsule filler, with a maximum speed of 48,000 capsules per hour, equipped with two dosing units for powders and pellets with relevant dosing size parts, two capsule transport size parts and a statistical weight control system model SWC. This MG2 technology will allow to fill capsules with phytopharmaceutical and nutraceutical products. Dr. Gustav Klein bought the capsule filler despite the COVID-19 crisis. That is why a remote procedure had to be defined to both run the FAT and carry out product validation. FATs are usually carried out at the MG2 headquarters in the presence of the customer, who checks the accuracy of both capsule filler operation and size change-over, who can touch the capsules and checks their integrity. The order is reviewed step by step, showing the customer the consistency between technical documentation and the supply. The recent hindrances to the movement, however, have forced MG2 to identify new solutions based on the integration of multimedia technologies with technical expertise of the Company staff. “In this first remote FAT we used two video cameras,” says Eng. Fabrizio Buffoni, MG2 Area Manager, “one fixed and one on the operator. Wearable technology allows MG2 to show all the components purchased by the customer. The live procedure totally corresponds to the Factory Acceptance protocol that we usually apply. It allows, in fact, to verify that the compliance with the order and that the machine operates correctly. In this specific case, the customer asked to weight some of his capsules once a production batch was finished. The capsules were then collected in three stages during one hour of production: at the beginning, at the end and in the middle of the batch production, they have been weighed one by one, subsequently emptied and weighed again. The goal”, continues Eng. Buffoni, “was to give the customer an evidence that the capsules had been filled as expected by him.” The remote procedure, which covers all the steps necessary for the correct execution of a FAT, involves sharing all the documents of both validation and order confirmation, strictly following what is displayed by the two cameras. The batch reports processed by the machine were made available to the customer in real time, thus overcoming the objective limits related to the physical distance. The test recording, lasting 3 working days of 8 hours each, is another tool that let the customer the possibility to objectively evaluate the test. “A key element of the FAT is the objective evaluation of the correct capsule filling” continues Eng. Buffoni, “an aspect which, in the case of the customer Dr. Gustav Klein, was highlighted by two specific tests: the SWC weight control system, which tests a capsule every 20 seconds and it was part of the supply, and a further statistics check requested by the customer. Specifically, we manually weighed the capsules on a scale in front of the camera, thus ensuring maximum reliability and objectivity of the filling process “. Furthermore, with the same remote technology, it was possible to verify all the machine documentation (user manual) and validation documentation, by connecting the customer and the MG2 specialist in charge. “Usually validations are part of the packages purchased by pharmaceutical companies. In order to produce a drug, in fact, the capsule filler must be validated according to specific regulations.” – continues Eng. Buffoni – “The customer can have his own validation procedures; alternatively, MG2 can supply them. Normally, nutraceutical companies are not particularly interested in validations. But this was not the case of Dr. Gustav Klein, who decided to acquire validations too, because he is a high-quality manufacturer of food supplements and homeopathic products: that’s why we could call him a parapharmaceutical supplier.” Quality, efficiency and proximity to the customer, well-known characteristics of the MG2 brand, have been enriched with the successful remote FAT for Dr. Gustav Klein.

  • COVID-19 EMERGENCY

    News: 

    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. Below you will find the main measures that Makro Labeling Srl has put in place to ensure the safety of its employees / collaborators for the benefit of the entire community of customers and suppliers and to guarantee - at the same time - the continuity of activities with our customers, where possible. In particular: The Committee for the verification and application of the rules established by the Shared Protocol was set up in the company. The Committee meets virtually every day to follow the evolution of the emergency and act accordingly. For security reasons, from the first day we reduced the organization of face-to-face meetings to a minimum, favoring remote communication tools such as webinars, skype calls, etc. We have activated the working mode in smartworking as much as possible and reduced the staff present in the production departments, using backward permits and holidays, always in such a way, however, to guarantee continuity of service. All our telephone numbers / contact points are manned, as usual. We confirm that, to date, no employee and collaborator of Makro Labeling Srl is affected by the COVID-19 virus and therefore subjected to restrictive individual health measures as required by the emergency protocol. For the protection of everyone's health, our office is currently not accessible to outsiders (suppliers can deliver, in compliance with company safety procedures, by agreement with the warehouse. For operational questions and specifics on current projects, we ask you to refer to your internal contacts at Makro Labeling Srl. We will take care of updating you with further communications in the case of new provisions that may be adopted following directives from the Competent Authorities. Cordial greetings Goito (MN), there March 24 2020

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

    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. The meeting was jointly organised by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) on 22 June 2020.
  • European regulators make recommendations drawing on lessons learnt from presence of nitrosamines in sartan medicines

    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.
  • Academia developing medicines for rare diseases to receive free EMA scientific advice

    News: 
    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. This helps them to navigate the regulatory process and ultimately to translate their discoveries into authorised, patient-focused medicines. However, feedback from academia showed that fees for protocol assistance (scientific advice for orphan medicines) represent a hurdle to engage with EMA. In light of these findings and the actions foreseen in the Agency's framework of collaboration with academia, the Regulatory Science Strategy to 2025 and the EMA SME action plan, EMA decided to include academia in the list of organisations PDF iconeligible for free protocol assistance as of 19 June 2020 . Eligible applicants will include public or private higher education establishments awarding academic degrees, public or private non-profit research organisations whose primary mission is to pursue research, and international European interest organisations. These entities should not be financed or managed by private for-profit organisations in the pharmaceutical sector or have concluded any agreement with pharmaceutical companies concerning their sponsorship or participation in a specific research project for which a fee exemption is sought. Fee incentives for orphan medicines are described in the ' PDF iconExplanatory note on general fees payable to the European Medicines Agency '.
  • METE PLASTİK HELPS FOR HEALTHCARE PROFESSIONALS BY PRODUCING FACE SHIELDS AGAINST COVID 19

    News: 

    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.

  • Coronavirus: An update from the Meech team

    News: 

    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. This will allow is to meet customer’s demands with the same high standards we usually work to. We will be reviewing this regularly and can reassure you that we are taking action to minimise risks, where possible. This includes: Risk Assessment We have carried out a full risk assessment of our headquarters. This includes; · Prioritising the departments most at risk and looking for alternative ways of working where necessary. · Restricting face to face meetings and running conference/video calls where possible. · Putting in place measures that allow staff with children and at-risk family members to look after them if needed, without disrupting business. Travel restrictions We have cancelled all non-essential travel both in terms of face to face meetings and overseas trips. Production isolation Having identified the production facility as a key area, we have restricted the physical interaction people have with this part of the business. This includes restricting entry to only key production personnel and prohibiting entry for external visitors. Communication We are issuing internal memos highlighting any new procedures and changes we are asking people to make. We will also be sending regular updates to our wider distributor network. Cleaning procedure We have established a cleaning rota for all communal areas, this is in addition to the increase in cleaning from our professional cleaning company. Working from home protocol We have now introduced a working from home policy where those who can are working from home. We have ensured everyone has the appropriate hardware for them to work effectively from home and allow a safe continuation of business. We have made every effort to balance the welfare of our team with the needs of the business. Whilst we hope these measures will only be temporary, we are confident that the company, its employees and distributors are well placed to deal with any challenges we face. We would also like to reassure you that whilst there is a chance of delays to orders in the future, at present, orders are being fulfilled as normal.

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

    News: 

    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). Given the medical emergency presented by COVID-19 and the importance of international cooperation to tackle this global crisis, the topic was high on the agenda of the bilateral meeting. Topics discussed included: Sharing of experience and common challenges in facilitating the development, review and availability of COVID-19 vaccines. Discussion about opportunities for cooperation on individualised/bespoke therapies for ultrarare diseases (e.g. gene therapies (advanced therapies/ATMPs); oligonucleotides) to jointly address their scientific and regulatory challenges. Real world evidence use to support regulatory decisions: through ICMRA, EMA and FDA have agreed to collaborate on observational research in COVID-19 as a model, specifically on vaccines surveillance, building international cohorts, and the use of medicines in pregnant women with COVID-19. Discussions focused on data provenance, quality and structure, on methods for generating evidence and opportunities to strengthen collaboration leveraging data from diverse digital sources to inform regulatory decisions. The partners agreed to collaborate on the development of a roadmap for international collaboration on real world evidence. Mutual recognition agreement (MRA) of good manufacturing practice (GMP) inspections: following the milestone reached in July 2019 with the full implementation of the MRA for certain human medicines, the partners discussed the next milestones. These include the expansion of the current MRA to veterinary medicines and the consideration to include vaccines and plasma-derived products by July 2022. Orphan and paediatric medicines: information sharing on initiatives on both sides of the Atlantic and discussion on possible cooperation in the area of data analysis for the characterisation of rare diseases. Notes The collaboration between EMA and the US FDA is outlined in the publication “Are the European Medicines Agency, US Food and Drug Administration, and Other International Regulators Talking to Each Other?”

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