Quality Management Systems (QMS) and KPIs in Pharmacovigilance
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Speaker : GRAEME LADDS
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When : Monday, November 18, 2024
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Time : 12 : 00 PM EST
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Graeme Ladds, Director of PharSafer, has over 30 years of experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1990 and becoming Head of Drug Safety & Medical Information, Graeme went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals and has also served as EU QP PV at many top ten Pharma Companies. The last twenty-one years have been spent in his consultancy company, PharSafer Associates Ltd, a niche CRO specializing in performing pharmacovigilance for many Companies around the world. During this time, Graeme has been involved in establishing Pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP PV for companies, and helping with regulatory inspections.
Graeme is also the inventor of RAPTAR – an automated safety case processing tool that enhances case processing accuracy, and speed and provides cost savings for Companies serious about safety.
Quality Management System (QMS) implementation in Pharma Companies is an expectation and a requirement from the legislation. QMS is not an extension of GMP which is the mistake made by a number of Companies. It is an over-arching system covering ALL of the Company's activities and not an offshoot of the GMP system.
QMS is also seen as an activity that begins with, is approved by, and is sustained by Senior Management in the Company to ensure that it is implemented fully, tested, and where necessary improvements made.
Such QMS systems have to be independent of any interference from any Departments which is why the individuals within QA only need to report to Senior Management and not have any findings influenced by any other Departments.
QMS is also misunderstood as being in place to ensure compliance only, but it is also to determine whether any performance improvements can be made to existing compliant systems or process improvements to gain greater efficiencies.
Areas Covered
- What are QMS and KPIs?
- Why are they required?
- How can they be implemented and maintained?
- Which areas can be covered by QMS & KPIs
Who Should Attend
- PV Compliance
- Head of Regulatory
- PV Case processing
- Clinical Staff
- EU QP PV
- Director/Manager of Pharmacovigilance
- PV QA
- Medical Information staff
Why Should You Attend
A QMS is a requirement for all sponsors of clinical trials; licence holders and CROs performing PV activities on behalf of sponsors and licence holders.
European post-marketing legislation spells out the requirements of a QMS expectation and ICH E6 covers from an international perspective all compliances required for aspects of clinical trials.
Sponsors, licence holders, and their CROs are expected to have a QMS in place to demonstrate that the data being generated is accurate and compliant. This course covers these aspects in terms of monitoring and improving systems, what systems should be monitored routinely, and how to look at QMS from a Risk perspective.
Topic Background
It is vital to understand that since pharmacovigilance activities are essential for protecting patients they have been conducted accurately, compliantly (in terms of content, format, accuracy and time) and using key performance indicators to supplement such compliance.
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$199.00
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