Month: July 2020
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ICMRA statement on clinical trials
Recently EMA has endorsed a joint statement on prioritisation of COVID-19 clinical trials published by the International Coalition of Medicines Regulatory Authorities (ICMRA). This statement is intended for all stakeholders, patients, investigators, researchers, academia, regulators, and the pharmaceutical industry. Refer below link to read Statement issued by ICMRA: http://icmra.info/drupal/news/statement_on_clinical_trials Medicines regulators from around the world…
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EMA pharmacovigilance training materials
The European medicines regulatory network has developed open access training materials, guidance, tools and templates to strengthen national pharmacovigilance systems and support Member States in the implementation of best practice. These materials are publicly available and can be useful for marketing authorisation holders, healthcare professionals, patient and consumer organisations and academia. Training include below topics:1…
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Distributional semantic methods for duplicate search
The presence of duplicates in any pharmacovigilance system can create misleading signals and therefore impact on the safety monitoring and potential regulatory actions. Hence detection and handling of duplicates by National Competent Authorities (NCAs), Marketing Authorisation Holders (MAHs) and Sponsors of clinical trials (Sponsors) is an important element of good case management. Uppsala monitoring center (UMC)…
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EMA make recommendations drawing on lessons learnt from presence of nitrosamines in 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. Nitrosamines are chemical compounds classified as probable human carcinogens on the basis of animal studies. However, there…