Medical Devices Periodic Safety Update Report (PSUR)
Duration : 90 Minutes
John E. Lincoln,
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 38 years experience in U.S. FDA-regulated industries, 24 as an independent consultant. John has worked with companies from start-up to Fortune 100, world wide. He specializes in quality assuranc Read more
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.
Why Should You Attend:
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.
Course Outline:
• What is a PSUR? Pharmaceuticals? Newly required Devices?
• Who compiles and submits a PSUR?
• How is a PSUR submitted? How often?
• Typical PSUR contents
• Basic PSUR format
• Objective of the PSUR program in the EU
• EMA and the PSUR
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
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:
• Senior management
• Regulatory Affairs
• Quality Assurance
• Production
• R&D and Engineering
• All personnel tasked with product safety information gathering and reporting.
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
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