Vibha Sharma
Senior Writer
Latest From Vibha Sharma
EU Coordination Key To Speeding Up Combined Studies Of Drugs & IVDs/Devices
An EU project has proposed solutions to address key bottlenecks in the approval and conduct of studies that involve the simultaneous investigation of a medicinal product, an IVD and/or a medical device.
EU Coordination Key To Speeding Up Combined Studies Of Drugs & IVDs/Devices
An EU project has proposed solutions to address key bottlenecks in the approval and conduct of studies that involve the simultaneous investigation of a medicinal product, an IVD and/or a medical device.
EMA Consults On Using RWD In Non-Interventional Studies
The European Medicines Agency has developed draft recommendations on the key methodological factors to consider when conducting and assessing observational studies with real-world data for regulatory decision-making throughout a medicine's lifecycle.
Egypt’s First Decentralized Trials Guideline Addresses Using Off-Site Nurses
Drawing references from the EU and US guidelines for decentralized clinical trials, the Egyptian FDA has framed draft requirements that sponsors should consider when planning to use off-site nurses in their drug and medical device studies.
Egypt’s First Decentralized Trials Guideline Addresses Using Off-Site Nurses
Drawing references from the EU and US guidelines for decentralized clinical trials, the Egyptian FDA has framed draft requirements that sponsors should consider when planning to use off-site nurses in their drug and medical device studies.
Netherlands Pilots New Scientific Advice Service For Clinical Trials
The Netherlands’ Central Committee on Research Involving Human Subjects is gauging sponsor demand for a new scientific advice service for clinical trials, which is for now free of charge.