Helpful Guidelines for Producing Your Systematic Reviews A Systematic Review (SR) is a synthesis of evidence that is identified and critically appraised to understand a specific topic. While SR covers a wide range of issues, its primary application lies in studying the safety/performance and effectiveness of drug treatments, medical device, or alternative treatments.
FDA Updates Recognized Consensus Standards Database with List 61 The U.S. Food and Drug Administration (FDA) has released List 61 which is an update to the Recognized Consensus Standards Database. It includes new standards, updated versions, and revisions to the extent of recognition for existing standards. Facts About This Update One significant
FDA Issues a Final Rule Amending the Quality System Regulation (QSR) The Food and Drug Administration (FDA) has issued a final rule amending the Quality System regulation (QSR). The title of the regulation has also been amended and will now be officially referred to as the Quality Management System Regulation (QMSR). The
What is PMCF? The goal of all post-market surveillance (PMS) activities is to ensure that the medical device performs as intended and that any potential safety issues are identified as quickly as possible. One of the most crucial parts of your post-market surveillance activities is the post-market clinical follow-up (PMCF). Post Market Clinical Follow
Webinar - EU Pharmaceutical Reform: Unveiling Draft Legislation Impacts What: Webinar – “EU Pharmaceutical Reform: Unveiling Draft Legislation Impacts” When: Thursday, February 29th, 2024, at 10:00 AM EST Where: Online Event How: Register Here Why: This webinar will explore the context of EU pharmaceutical reform and help identify the main changes when
Strategies for Successful PMCF under EU MDR: Unlocking the Mystery – Webinar in partnership with Medtech Intelligence What: Webinar in coordination with Medtech Intelligence - “Strategies for Successful PMCF under EU MDR: Unlocking the Mystery” When: March 6th, 2024, 10:00 am – 11:00 am EST Where: Online Event How: Register Here -
Webinar - Practical Advice and Next Steps to Ensure PLM Portal Readiness What: Webinar – “Practical advice and next steps to ensure PLM portal readiness” When: Tuesday, March 5th, 2024, at 10:00 AM EST Where: Online Event How: Register Here Why: This webinar will explore the EMA's PLM portal, spotlighting recent activities and data
All EU Clinical Trials to be Transitioned to the New CTIS Portal by January 2025 - Don’t Wait, Act Now! Since January 2022, the new Clinical Trial Regulation (CTR) has been in force, which replaced the Clinical Trial Directive (CTD). With the CTR, also a new online portal for clinical trials, the
Regulatory Submissions, Information, and Document Management Forum (RSIDMF) – February 12-14, 2024 Celegence invites you to join us for the Regulatory Submissions, Information, and Document Management Forum (RSIDM) from February 12-14, 2024, in North Bethesda, Maryland, USA. Meet our team of experts at Booth 106 to speak directly about how our full spectrum
EMA Update on On-site GMP and GDP Inspections Approach for 2024 The latest news on the approach in 2024 by the GMP/GDP Inspectors Working Group is that the validity of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) certificates has been extended until 2024 or until the completion of the next
