On 1 July 2015, the Common Arab Guidelines on good vigilance practices became effective. The Guidelines represented fundamental changes to pharmacovigilance practice and followed the EU guidelines of June 2012.
This intensive two-day course will look at the various topics and their practical application from the perspective of the introduction of the EU guidelines. The course will include experiences of inspections and audits following implementation and will identify what the main focus points have been.
This interactive course will help you:
Anyone involved in pharmacovigilance and regulatory activities – including pharmacovigilance case processing, local QPPVs, medical directors, drug safety managers, QA auditing, PSUR writers, and any company managers and licence holders wanting to know what impact this will have on their business practices.
An introduction to the PV structure
Module I – quality management systems
Module II – the pharmacovigilance system master file (PSMF)
Module III – pharmacovigilance inspections
Module IV – pharmacovigilance audits
Module V – risk management plans (RMPs)
Module VI – adverse reaction reporting (part 1)
Module VI – adverse reaction reporting (part 2)
Module VII – periodic safety update reports (PSURs)
Module IX – signals and their management
Graeme Ladds, Director of PharSafer, has over 30 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, he went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals. He then set up his consultancy and specialist CRO company, PharSafer Associates Ltd, where he has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.
|21-22 Oct 2019|
|21-22 Oct 2019||Venue not yet confirmed||GBP 1,499.00
Until 2 Sep*
* Note the early booking discount cannot be combined with any other offers or promotional code