Clinical Quality Management Systems
With increasing clinical quality standards required by inspectors, there is currently no harmonised regulatory guidance for clinical quality management systems (CQMS), although there are multiple documents from different sources across the pharmaceutical and medical device industries. The regulators however, both in Europe and the US, expect an effective QMS to be in place for clinical development. Organisations are struggling to effectively implement and integrate these QMS standards, including ISO 9000 principles, ICH10 for CQMS and ICH GCP R2 and R3 CQMS requirements.
This course will provide essential information and guidance to help you achieve regulatory compliance in this evolving area of clinical quality, including EMA guidance on computerised systems and ICH GCP R3 data governance.
Benefits of attending:
- Understand developing regulatory requirements for clinical quality management systems (CQMS)
- Review proposed CQMS framework
- Consider best practice in key CQMS areas
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I really enjoyed the course. Content was very interesting, presentation material well done and it was possible to ask lots of questions. Laura is a very experienced speaker and...