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Investigational Medicinal Products (IMPs): A Comprehensive Guide for . . . The clinical trials sector continues experiencing substantial growth, with investigational medicinal products (IMPs) serving as the cornerstone of pharmaceutical innovation and drug development As regulatory frameworks evolve and breakthrough therapies advance through development pipelines, understanding the intricacies of IMP development, manufacturing, and compliance has become increasingly
Regulating international clinical research: an ethical framework for . . . Abstract The global distribution of clinical trials is shifting to low-income and middle-income countries (LMICs), and adequate regulations are essential for protecting the rights and interests of research participants in these countries However, policy-makers in LMICs can face an ethical trade-off: stringent regulatory protections for participants can lead researchers or sponsors to conduct
What is the IVDR and how does it impact clinical trial assays? The In Vitro Diagnostic Regulation (IVDR) represents a significant milestone in the European Union's regulatory landscape for medical devices Its implementation brings forth substantial changes, particularly affecting clinical trial assays Understanding these changes and adapting accordingly is crucial for ensuring compliance and maintaining the integrity of clinical trial data In this
Guidance for Clinical Investigators, Sponsors, and IRBs In the years since the IRB and IND regulations issued, changes in the conduct of clinical trials (e g , increased use of multi-center studies, international trials) have complicated the reporting
Pharmaceutical Labelling | Requirements | Pharma | Clinical Trials Key points about the importance of pharmaceutical labelling within clinical trials include: Regulatory compliance: Clinical trials are subject to strict regulations to ensure patient safety and data quality Accurate pharmaceutical labelling ensures that medicinal product information, usage and dosage instructions, warnings and precautions are
Comparison of the Latin America Regulation Landscape and International . . . Keywords: Latin America regulations, Marketing authorization procedures, Innovative clinical trial designs, Expedited regulatory pathways, Reliance pathways, New clinical evidence approach Introduction The need to provide innovative drugs promptly to patients to fulfill unmet medical needs is changing the drug development scene
The Clinical Trials Regulation The rules established in the Regulation will be supported through a dedicated EU Portal and Database (the Clinical Trials Information System) that will become the single entry point for submitting CTs information in the EU and will support the daily business processes of Member States and sponsors throughout the life cycle of their CTs
Life Sciences: Reforms on the Horizon for Clinical Trials It amends the Medicine for Human Use Clinical Trials) Regulations 2004 in the biggest overhaul of UK legislation for Clinical Trials in almost two decades It is hoped that the new regulations will place the UK at the forefront of innovation regulation for clinical trials whilst protecting the interests of trial participants