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 R2 CQMS requirements.
This course will provide essential information and guidance to help you achieve regulatory compliance in this evolving area of clinical quality. The interactive programme will discuss the proposal for a new industry best practice CQMS framework as well as the new EMA TMF guideline requirements and implications for CQMS.
Benefits of attending:
This course is aimed at anyone working in clinical research or associated functions, including regulatory affairs and document management, who needs to know how to establish, maintain, monitor and improve a CQMS that focuses on product quality and compliance to GCP.
The programme will also be of value to those working in quality assurance and quality improvement roles in clinical research, management responsible for governance of CQMS and anyone working with or in clinical research who needs to comply with the new requirements for CQMS, including study sites.
It is ideal for those implementing a CQMS, those wanting to share best practice and anyone wanting an update on new developments in this area.
Dr Laura Brown is an independent pharmaceutical QA, management and training consultant and senior lecturer for the MSc in Clinical Research at the School of Pharmacy, University of Cardiff. Laura has more than 20 years’ experience of quality assurance and managing international clinical trials. She has worked for several companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International and has consulted with numerous pharmaceutical companies and suppliers to the pharmaceutical industry as well as academic institutions concerning quality management. Laura has an MBA with specialisation in project management, including quality assurance.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
17-18 Nov 2022
Course code 11767
Until 13 Oct
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.
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 she knows how to get the audience's attention.
Nov 14 2019
Process Document Manager , Takeda Pharmaceuticals International AG
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training expert Aleksandra Beer to discuss your requirements:
Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: