Clinical Research Solutions
August 2022 EMA Regulatory and Procedural Guideline Parallel distributors are only required to inform the EMA of changes to the labelling or leaflet related to any update of the annexes of marketing...
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If a marketing authorisation is planned to be submitted in England, Scotland, and Wales (GB), an MHRA-approved paediatric investigational plan (PIP) is required. Up until January 1, 2021, PIPs were...
Clinical Research Solutions
News July 28, 2022 The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies (HMA) has published its third workplan that sets key actions to be delivered between 2022–25. The new...
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The Europe Introduction - EU Implementation Guide has been prepared by the European Medicines Agency (EMA) upon consultation with different stakeholders (representatives of marketing authorisation...
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What is ILAP? What benefits does ILAP provide? How do you access it? With the dust of Brexit settling, the question on most people’s lips (well, those of us in the healthcare sector anyway!) was:...
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Draft Guidance July 2022 This guideline provides recommendation to promote a consistent approach in designing, conducting, and interpreting enzyme- or transporter-mediated in vitro and clinical...
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EMA Pre-authorisation guidance Table of contents 1. Types of applications and applicants 2. Steps prior to submitting the application 3. Preparing the dossier 3.1 Product name, product information...
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The Good Clinical Practice (GCP) Inspectors Working Group has developed procedures for the coordination, preparation, conduct and reporting of GCP inspections requested by the European Medicines...
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This guidance document aims to provide interested parties with appropriate guidance on procedural aspects to facilitate the consultation procedure to the European Medicines Agency (EMA) by notified...
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News 01/07/2022 On 30 June, regulators from around the world discussed emerging evidence to support adaptation of COVID-19 vaccines as the SARS-COV-2 virus continues to evolve during a workshop...