Scheduled In-house

Vigilance Training Courses

Our vigilance 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.

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.

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  • Next: 17 May 2023 Live online
  • Also: 25 Jul 2023 Live online
  • Also: 6 Oct 2023 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: 20-21 Apr 2023 Live online
  • Also: 24 Jul 2023 Live online
  • Also: 5 Oct 2023 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: 22-24 Mar 2023 Live online
  • Also: 7-9 Jun 2023 Classroom
  • Also: 20-22 Sep 2023 Live online
  • Also: 11-15 Dec 2023 Live online

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: 18-19 Apr 2023 Live online
  • Also: 20-21 Jul 2023 Live online
  • Also: 18-19 Oct 2023 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: 2 Jun 2023 Live online
  • Also: 1 Dec 2023 Live online

An Essential Overview of Medical Information

Updated for 2023

Live online
Focused

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
  • Presented by Dr Graeme Ladds
  • Next: 31 Jan 2023 Live online
  • Also: 18 May 2023 Live online
  • Also: 11-12 Sep 2023 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: 22-23 Jun 2023 Live online

Cosmetovigilance

Updated for 2023

Live online
Focused

This course will provide a comprehensive overview to Cosmetogivilance in Europe, the USA and the Rest of the World (ROW). It will cover the applicable legislation, the regulatory requirements, what needs to be reported, the role of the Responsible Person, borderline products and promotional claims. Essentially it will provide key guidance for manufacturers and distributors on how to comply with the regulatory requirements, and will be valuable for pharmaceutical and medical device companies looking to access the cosmetic market.

  • 12 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 6-10 Mar 2023 Live online
  • Also: 27-29 Jun 2023 Live online
  • Also: 6-10 Nov 2023 Live online

European Post Marketing Pharmacovigilance - Including the EMA/PRAC deliberations and Brexit implications

New for 2023

Live online
Focused

This course provides a comprehensive overview of key post-market pharmacovigilance activities required as the foundation for further understanding of new EU legislation that was introduced in 2012 and has undergone over 20 updates in the last 10 years.

  • Presented by Dr Graeme Ladds
  • Next: 29-30 Jun 2023 Live online
  • Also: 4-5 Oct 2023 Live online

Introduction to Veterinary Pharmacovigilance

Live online
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: 14-16 Jun 2023 Live online
  • Also: 11-13 Oct 2023 Live online

Pharmacovigilance

Live online
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
  • + 4 more
  • Next: 17 Mar 2023 Live online
  • Also: 12 Jul 2023 Live online
  • Also: 29-30 Nov 2023 Live online

Pharmacovigilance Aspects of Licensing Agreements

Live online
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 Joanne Flitcroft
  • and Dr Graeme Ladds
  • Next: 22-24 Feb 2023 Live online
  • Also: 30 May-1 Jun 2023 Live online
  • Also: 2-4 Oct 2023 Live online

Pharmacovigilance for Drug Safety, Regulatory Affairs and PV Auditors - Broadening your Knowledge

New for 2023

Live online
Focused

This course has been designed for those wishing to learn more than the basics of Pharmacovigilance, who want to expand their knowledge and explore what they would like to understand next in this complex area.

  • 18 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 22-23 May 2023 Live online
  • Also: 28-29 Sep 2023 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: 15-16 May 2023 Live online
  • Also: 19-20 Oct 2023 Live online

Practical Requirements of the Arab Pharmacovigilance Guidelines

Updated for 2023

Live online
Focused

Practical guidance on how to comply with the pharmacovigilance requirements in the Middle East

  • 12 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 17-18 Apr 2023 Live online
  • Also: 3-4 Jul 2023 Live online
  • Also: 14-17 Nov 2023 Live online

Signal Detection and Regulatory Expectations

Live online
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