A two-day course that will ensure you comply with new regulatory requirements.
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.
Laura Brown (More...)
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.
Laura Brown (More...)
Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years’ experience of quality assurance and regulatory requirements in clinical trials in the pharmaceutical industry. She has worked in senior positions for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality systems including data protection and data integrity in clinical trials. She was Chairman of the ACRPI GCP Forum for six years. She regularly writes on pharmaceutical regulatory issues in clinical trials
NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:
30% off the 2nd delegate; 40% off the 3rd delegate; 50% off the 4th delegate
Choose your date below - or reserve your place with no obligation for 7 days at ipi.academy: Reserve now | |||
17-18 Nov 2022 Live webinar 09:30-17:00 UK (London) |
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17-18 Nov 2022 Live webinar 09:30-17:00 UK (London) |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 13 Oct* |
Enrol now
to attend Live webinar |
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16-17 Mar 2023 Live webinar 09:30-17:00 UK (London) |
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16-17 Mar 2023 Live webinar 09:30-17:00 UK (London) |
GBP 1,299 1,099 EUR 1,869 1,589 USD 2,129 1,817 Until 9 Feb 23* |
Enrol now
to attend Live webinar |
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6-7 Jul 2023 Face-to-face, Rembrandt Hotel London 09:00-17:00 UK (London) |
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6-7 Jul 2023 Face-to-face Rembrandt Hotel London 09:00-17:00 UK (London) |
GBP 1,499 1,299 EUR 2,149 1,869 USD 2,449 2,137 Until 1 Jun 23* |
Enrol now
to attend Face-to-face Rembrandt Hotel London |
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16-17 Nov 2023 Live webinar |
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16-17 Nov 2023 Live webinar |
GBP 1,299 1,099 EUR 1,869 1,589 USD 2,129 1,817 Until 12 Oct 23* |
Enrol now
to attend Live webinar |
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Learn more about our face-to-face and webinar training formats.
* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.