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Substantial revision to course on variations to marketing authorisations in Europe

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: Assuring Data Integrity in Clinical Research

We are pleased to announce the release of a new course: Assuring Data Integrity in Clinical Research Pharmaceutical, biotechnology and medical device companies and clinical researchers need to assure regulatory authorities of the reliability of the data that they generate during product development and testing – that is, to demonstrate data integrity. Practices that provide assurance

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New Course: Assuring Data Integrity in the Manufacture of Medicinal Products

We are very happy to announce the release of a new course: Assuring Data Integrity in the Manufacture of Medicinal Products. Pharmaceutical and biotechnology companies and researchers need to assure regulatory authorities of the reliability of the data that they generate or acquire during product development and manufacturing – that is, to demonstrate data integrity. Data

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