PSURs are pharmacovigilance and device adverse events documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorization in the EU. The purpose is to harmonize and strengthen benefit-risk review of medical products across the European Economic Area.
PSURs are pharmacovigilance or medical device post-market review documents intended to provide an evaluation of the risk-benefit balance of a medical product at defined time points after its authorisation. The objective of the PSUR is to present a comprehensive and critical analysis of the benefit-risk balance of the product, including the taking into account new or emerging safety / post market information. EU EMA and national competent authorities assess information in PSURs to determine if there are new risks identified for a product and/or if its benefit-risk balance has changed. A PSUR assessment can determine if further investigations on a specific issue are needed, or if an action is necessary to protect public health (e.g. an update of the information provided to healthcare professionals and patients). Marketing authorization holders (MAHs) are legally required to submit PSURs.
MAHs are required to submit all PSURs in the EU to a central PSUR repository. Use of the PSUR repository is mandatory. MAHs for devices and active substances and combinations of active substances that are subject to assessment at EU level must submit the relevant PSURs according to the requirements set up in the list of EU reference dates (EURD) list. The list does not include substances assessed at national level; the frequency of submission is established at national level. The EURD list is a legally binding document and MAHs are legally responsible for complying with its requirements. EMA carries out PSUSA procedures to assess PSURs, even if they are subject to different marketing authorisations and are authorised in different EU Member States.
Areas Covered in the Webinar:This webinar will provide valuable assistance to all regulated drug and device companies that sell product in the EU. The employees who will benefit include:
John E LincolnPrincipal, J E Lincoln and Associates
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years’ experience in U.S. FDA-regulated industries, 22 as a full-time consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA.
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