Colin

New course on good manufacturing practices for medical devices

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We are delighted to announce the release of a new course: Quality Management System Requirements for Medical Devices under ISO 13485:2016 and FDA QMSR.  Manufacturers of medical devices need to provide assurance of the quality of their products. Central to this effort is the establishment and maintenance of a quality management system (QMS). The internationally recognized […]

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Substantial revision to course on variations to marketing authorisations in Europe

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We are happy to announce a substantial revision to the course SUB06: Variations to Marketing Authorisations in Europe. The course is now fully up to date with the amendments to European Union law effected by Commission Delegated Regulation (EU) 2024/1701, which came into force in 2025. It is also up to date with the amendments proposed

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New course on Good Clinical Laboratory Practice

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We are delighted to announce the release of a new course: Good Clinical Laboratory Practice The work of analytical laboratories in examining biological samples is crucial in the diagnosis and treatment of patients, in public health screening, and in clinical research. Various published guidelines and consensus standards set out criteria that laboratories should meet to provide

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New course on Good Quality Control Laboratory Practice

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We are pleased to announce the release of a new course: Good Quality Control Laboratory Practice [course details]. The medicinal products industry is heavily regulated by governments. Within the industry’s Good Manufacturing Practice (GMP) framework, analytical laboratories engaged in quality control (QC) of starting materials, intermediates, bulk products, finished products, and packaging need to comply with relevant

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New course on the 505(b)(2) application for marketing approval in the USA

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A 505(b)(2) New Drug Application (NDA) is a submission to the Food and Drug Administration (FDA) for approval to market a drug in the USA. It differs from a ‘stand-alone’ NDA in that some of the data on which the applicant relies to demonstrate safety and efficacy have been obtained from publicly available sources rather

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EU extends grace period for transition to Medical Device Regulation

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The European Union, recognising that many medical device manufacturers would be unable to meet the deadline for transition to the requirements of the Medical Device Regulation (MDR), have extended the grace period allowed for compliance with the new law. Prominent among the reasons for the postponement of the deadline is the inadequate number of third-party

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