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Pharmacovigilance

This course provides a practical guide to both producing and maintaining the PSMF to ensure compliance and has been fully revised to include the latest updates.

Understand the relationship between RMPs and 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.

Advanced Pharmacovigilance

23-25 Sep 2020

Also on: 17 Mar 2021

A practical guide to understanding the role of pharmacovigilance.

An Essential Overview of Pharmacovigilance

5 Oct 2020

Also on: 26 Apr 2021

Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in drug safety.

Pharmacovigilance

7-9 Dec 2020

Also on: 21 Jun 2021

This course will provide you with practical advice on 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

Pharmacovigilance Aspects of Licensing Agreements

9 Oct 2020

Also on: 15 Apr 2021

This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.

Pharmacovigilance QMS & Inspection Preparation

19-20 Nov 2020

Also on: 13 May 2021

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

Signal Detection and Regulatory Expectations

2-3 Nov 2020

Also on: 3 May 2021