Vigilance Training Courses

Pharmacovigilance has undergone rapid regulatory change in recent years and become one of the most demanding aspects of the pharmaceutical industry to both understand and comply with. Our training courses have been designed for drug safety professionals and will offer practical advice on key topics and the latest regulatory developments in this increasingly important field.

  • Next: 20 Jan 2022 Live online
  • Also: 5 Apr 2022 Classroom
  • Also: 12 Jul 2022 Live online
  • Also: 4 Oct 2022 Classroom

A Practical Guide to Producing and Maintaining the PSMF

Live online, Classroom
Focused

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.

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 13 Jan 2022 Live online
  • Also: 4 Apr 2022 Classroom
  • Also: 11 Jul 2022 Live online
  • Also: 3 Oct 2022 Classroom

A Practical Guide to Writing Risk Management Plans (RMPs)

Live online, Classroom
Focused

Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 1-3 Mar 2022 Live online
  • Also: 7-9 Jun 2022 Classroom
  • Also: 21-23 Sep 2022 Live online
  • Also: 7-9 Dec 2022 Classroom

Advanced Pharmacovigilance

Live online, Classroom
Focused

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.

  • 18 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 1-2 Feb 2022 Live online
  • Also: 4-5 May 2022 Live online
  • Also: 21-22 Nov 2022 Live online

Advanced Veterinary Pharmacovigilance

Live online
Focused

Including the main requirements of Volume IXB, an update on the proposed EU Regulation (2019/6) on Veterinary Medicinal Products and the impact of Brexit

  • 12 CPD hours
  • Presented by Mr Declan O'Rourke
  • Next: on request

An Essential Overview of Medical Information

Bespoke

In one day understand the role of medical information, the legal requirements for a medical information service, clarify the guidelines for medical information and advertising, receive practical advice on Black Triangle products and additional monitoring

  • 6 CPD hours
  • Next: 8 Apr 2022 Live online
  • Also: 10 Oct 2022 Live online

An Essential Overview of Pharmacovigilance

Live online
Focused

A practical guide to understanding the role of pharmacovigilance.

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: on request

EC Medical Devices Vigilance System and Post Marketing Surveillance

Bespoke

This conference provides a unique opportunity to meet competent authorities, notified bodies, lawyers, consultants and manufacturers to understand and discuss the regulatory and legal requirements with respect to post-marketing surveillance including vigilance.

  • 12 CPD hours
  • Next: 26-27 Apr 2022 Live online
  • Also: 5-6 Jul 2022 Classroom
  • Also: 18-19 Oct 2022 Live online

Introduction to Veterinary Pharmacovigilance

Live online, Classroom
Focused

A basic training course for those working on drug safety in the EU. This course has been designed to provide basic training and a good introduction to those concerned with veterinary pharmacovigilance. *INCLUDES: Interactive workshop and discussion sessions*

  • 12 CPD hours
  • Presented by Mr Declan O'Rourke
  • Next: 21-23 Jun 2022 Live online
  • Also: 20-22 Sep 2022 Classroom
  • Also: 14-16 Dec 2022 Live online

Pharmacovigilance

Live online, Classroom
Focused

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

  • 18 CPD hours
  • Presented by Dr Glyn Belcher
  • + 6 more
  • Next: on request

Pharmacovigilance / GCP Audit Report Writing

Bespoke

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.

  • 6 CPD hours
  • Next: 25 Apr 2022 Live online
  • Also: 13 Jul 2022 Classroom
  • Also: 17 Oct 2022 Live online

Pharmacovigilance Aspects of Licensing Agreements

Live online, Classroom
Focused

This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • and Joanne Flitcroft
  • Next: 23-24 May 2022 Live online
  • Also: 16-17 Nov 2022 Live online

Pharmacovigilance QMS & Inspection Preparation

Live online
Focused

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

  • 12 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 22-23 Feb 2022 Classroom
  • Also: 16-17 May 2022 Live online
  • Also: 29-30 Nov 2022 Live online

Signal Detection and Regulatory Expectations

Live online, Classroom
Focused

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

  • 12 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: on request

The Arab Pharmacovigilance Guidelines

Bespoke

Practical tips on introducing a compliant pharmacovigilance system

  • 12 CPD hours