European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation entered into force from 31 January 2023. It aims…
The European Medicines Agency (EMA) has released a draft guideline on the medical device quality…
EMA has recently published the first of a series of guidance documents to help applicants…
On 1st of Feb. 2019 the FDA announced the availability of draft guidance "Rare Diseases:…
The sponsor should ensure that all trial-related tasks, which are outsourced to the contract research…
Trial master file (TMF) plays a key role in the successful management of a trial…