European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation entered into force from 31 January 2023. It aims to ensure the EU offers…
The European Medicines Agency (EMA) has released a draft guideline on the medical device quality requirements for drug–device combinations (medicines…
EMA has recently published the first of a series of guidance documents to help applicants prepare for obligations stemming from…
On 1st of Feb. 2019 the FDA announced the availability of draft guidance "Rare Diseases: Common Issues in Drug Development".…
The sponsor should ensure that all trial-related tasks, which are outsourced to the contract research organisation (CRO)/vendor, are carried out…
Trial master file (TMF) plays a key role in the successful management of a trial by the investigator/institutions and sponsors.…
A new European Medicines Agency (EMA) guideline on Good Pharmacovigilance Practices (GVP) came into effect on 8 November 2018, providing…
Human beings make mistakes regardless of their experience, intelligence, motivation or vigilance. Some people say that error is the inevitable…
Unlike the situation for new drugs, it is not necessary to conduct clinical trials for every new medical device before…
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued its annual GCP inspections metrics report for the 12-month period…