6th Annual Life Science Regulatory Intelligence & Strategy Conference Celegence invites you to join us for the In-Person 6th Annual Life Science Regulatory Intelligence & Strategy Conference presented by Q1 Productions from April 10-11, 2024, in Baltimore, MD, USA. This event brings together global intelligence, strategy, policy and legal experts to share
Dossplorer - Revolutionizing Regulatory Affairs In the fast-paced world of pharmaceuticals, navigating the complexities of regulatory affairs can be daunting. However, with the right tools and solutions, pharmaceutical companies can streamline their processes, save time, and reduce costs significantly.The RSIDM 2024 forum highlighted a crucial focus on improving and optimizing organizational processes and
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
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
An Inside Look: The European Commission Publishes the First Union List of Critical Medicines Shortages of medicinal products are an increasing problem in the EU, therefore, one of the objectives of the new proposed European pharma REFORM is to enhance the security of supply and ensure medicines are available to patients in
FDA Proposes Benefit-Risk Assessment Guidance for New Drug and Biological Products In October 2023, the FDA introduced a significant guidance document, “Benefit-risk assessment for new drug and biological products”, for the pharmaceutical industry. This guidance focuses on the assessment of benefit-risk for new drugs and biological products. This comprehensive guideline aims to
FDA Issues Guidance for Industry on Biosimilar Labeling Stay Informed, Stay Prepared The FDA is charting the course for the future of biosimilars with its recent release. On September 15, 2023, the FDA unveiled its draft guidance document, "Labeling for Biosimilar and Interchangeable Biosimilar Products," along with a Notice of Availability (NOA).
