Scheduled In-house

Vigilance Training Courses

Our pharmacovigilance 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 a rapid regulatory change in recent years and become one of the most demanding aspects of the pharmaceutical industry to both understand and comply with.

We also provide training in vigilance and adverse event management for medical devices and pharmacovigilance for veterinary medicinal products and cosmetics.

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  • Next: on request

Pharmacovigilance

Bespoke

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

  • 18 CPD hours Focused
  • Next: on request

Practical Requirements of the Arab Pharmacovigilance Guidelines

Bespoke

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

  • 12 CPD hours Focused
  • Next: 18-20 Sep 2024 Live online
  • Also: 9-13 Dec 2024 Live online

Advanced Pharmacovigilance

Live online

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 Focused
  • Presented by Dr Graeme Ladds
  • Next: 2-3 Jul 2024 Live online
  • Also: 9-10 Oct 2024 Live online

Advanced Veterinary Pharmacovigilance

Live online

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 Focused
  • Presented by Declan O'Rourke
  • Next: 11-12 Jul 2024 Live online
  • Also: 14-15 Oct 2024 Live online

Cosmetovigilance

Updated for 2024

Live online

This course will provide a comprehensive overview of cosmetogivilance in Europe, the USA and the Rest of the World (ROW). 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 Focused
  • Presented by Dr Graeme Ladds
  • Next: 29 Nov 2024 Live online

An Essential Overview of Medical Information

Updated for 2024

Live online

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 Focused
  • Presented by Dr Graeme Ladds
  • Next: 9-10 Sep 2024 Live online

An Essential Overview of Pharmacovigilance

Live online

A practical guide to understanding the role of pharmacovigilance.

  • 6 CPD hours Focused
  • Presented by Dr Graeme Ladds
  • Next: 15-17 Jul 2024 Live online
  • Also: 4-8 Nov 2024 Live online

European Post Marketing Pharmacovigilance - Including the EMA/PRAC Deliberations and Brexit Implications

New for 2024

Live online

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.

  • Focused
  • Presented by Dr Graeme Ladds
  • Next: 26-27 Jun 2024 Live online
  • Also: 2-3 Oct 2024 Live online

Introduction to Veterinary Pharmacovigilance

Live online

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 Focused
  • Presented by Declan O'Rourke
  • Next: 10 Jul 2024 Live online
  • Also: 27-28 Nov 2024 Live online

Pharmacovigilance Aspects of Licensing Agreements

Live online

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

  • 6 CPD hours Focused
  • Presented by Joanne Flitcroft
  • and Dr Graeme Ladds
  • Next: 30 Sep-2 Oct 2024 Live online

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

New for 2024

Live online

This course has been designed for those wishing to expand their knowledge in pharmacovigilance and explore what they would like to understand next in this complex area.

  • 18 CPD hours Focused
  • Presented by Dr Graeme Ladds
  • Next: 26-27 Sep 2024 Live online

Pharmacovigilance QMS & Inspection Preparation

Live online

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

  • 12 CPD hours Focused
  • Presented by Dr Graeme Ladds
  • Next: 10 Oct 2024 Live online

Post-Market Surveillance - Practical Application for Medical Devices and IVDs

New for 2024

Live online

In this practical, one-day course, learn the regulatory requirements needed for successful post-market surveillance of medical devices and IVDs.

  • 6 CPD hours
  • Presented by Anne Jury
  • and Karen Pearson
  • Next: 5 Aug 2024 Live online
  • Also: 10 Oct 2024 Live online

A Practical Guide to Producing and Maintaining the PSMF

Live online

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 Focused
  • Presented by Dr Graeme Ladds
  • Next: 1 Aug 2024 Live online
  • Also: 9 Oct 2024 Live online

A Practical Guide to Writing Risk Management Plans (RMPs)

Live online

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

  • 6 CPD hours Focused
  • Presented by Dr Graeme Ladds
  • Next: 1-2 Jul 2024 Live online
  • Also: 12-15 Nov 2024 Live online

Signal Detection and Regulatory Expectations

Live online

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 Focused
  • Presented by Dr Graeme Ladds
  • Next: 8-9 Jul 2024 Live online
  • Also: 8-9 Oct 2024 Live online

Understanding Pharmacovigilance Regulations in APAC

New for 2024

Live online

Pharmacovigilance regulations in Asia are dynamic and fast-changing. As the Asia-Pacific region becomes increasingly important for pharmaceutical companies, it's vital to ensure compliance and safety by staying informed of the latest regulatory developments.

  • 6 CPD hours Focused
  • Presented by Ms Marylene Zhan
  • + 4 more