There are fundamental changes to pharmacovigilance practice described in these guidelines which follow the EU guidelines, issued and implemented in June 2012. This intensive two-day course will look at the various new topics and their practical application.
21-22 Oct 2019
The new Arab pharmacovigilance guidelines were issued in May 2015 with their introduction on 1 July 2015. There are fundamental changes to pharmacovigilance practice described in these guidelines which follow the EU guidelines, issued and implemented in June 2012. This intensive two-day course will look at the various new 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 will be.
Anyone involved in pharmacovigilance and regulatory activities, including pharmacovigilance case processing; local QP PVs; 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.
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