The European Medicines Agency (EMA) has released a draft guideline on the medical device quality requirements for drug–device combinations (medicines that include a medical device). The guideline (dated 29 May 2019) addresses the new obligations in Regulation (EU) 2017/745 on medical devices, in...
EMA has recently published the first of a series of guidance documents to help applicants prepare for obligations stemming from the new EU regulations on medical devices . The new regulations introduce new roles and responsibilities for EMA and national competent authorities (NCAs) in relation to certain...
On 1st of Feb. 2019 the FDA announced the availability of draft guidance "Rare Diseases: Common Issues in Drug Development". This guidance revises and replaces the previous draft guidance of the same name from 2015. Comments and suggestions regarding this draft document should...
The sponsor should ensure that all trial-related tasks, which are outsourced to the contract research organisation (CRO)/vendor, are carried out in accordance with the protocol, written agreements, GCP and local requirements. Especially, when the trial tasks are outsourced to different CROs/vendors at the same time,...
Trial master file (TMF) plays a key role in the successful management of a trial by the investigator/institutions and sponsors. The essential documents and data records stored in the TMF enable the operational staff as well as monitors, auditors and inspectors to evaluate compliance with the...
A new European Medicines Agency (EMA) guideline on Good Pharmacovigilance Practices (GVP) came into effect on 8 November 2018, providing recommendations for pharmacovigilance in paediatric populations. Adverse reactions to medicinal products in the paediatric population need specific evaluation, as they may substantially differ - in terms...
Human beings make mistakes regardless of their experience, intelligence, motivation or vigilance. Some people say that error is the inevitable downside of having a brain! One definition of “human error” is “human nature”. In another words, it is impossible not to make error when conducting...
Unlike the situation for new drugs, it is not necessary to conduct clinical trials for every new medical device before it is approved and marketed. This depends on the device classification. Although each country or region defines the device classification in somewhat different ways, they each...
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued its annual GCP inspections metrics report for the 12-month period from 1.Apr.2016 to 31.Mar.2017. Of 15 sponsor inspections, all sponsors had at least one major and/or critical finding. This is higher than in the previous 12-month...
Over the last decade, there has been a significant increase in the use of electronic systems for capture and handling of data in clinical research. In order to maintain the integrity of the data created and handled by these systems, there are several requirements to...
