This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the 2017 update.
Understand RMPs relationship to safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance
This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing
25-27 Sep 2019
Also on: 25 Mar 2020
Book by 16 Aug to save
£300 / €420 / $468
Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in drug safety.
24-26 Jun 2019
Also on: 2 Dec 2019
This course will provide you with practical advice in preparing an effective audit report, to ensure your readers understand the findings and the key messages you are trying to convey. Examples of common issues and pitfalls will be discussed to enable you to improve your audit writing skills.
We can customise this course to meet your requirements.
This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance
8 Oct 2019
Also on: 2 Apr 2020
Book by 23 Aug to save
£100 / €140 / $156
This course is designed to help understand pharmacovigilance Quality Management Systems (QMS) and risk based audits
11-12 Nov 2019
Also on: 14 May 2020
This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement
25-26 Nov 2019
Also on: 5 May 2020