Graeme Ladds

Graeme Ladds, Director of PharSafer, has over 30 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, he went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals. He then set up his consultancy and specialist CRO company, PharSafer Associates Ltd, where he has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.

  • Next: 2-4 Nov 2022 Live online
  • Also: 6-10 Mar 2023 Live online
  • Also: 27-29 Jun 2023 Classroom
  • Also: 6-10 Nov 2023 Live online

European Post Marketing Pharmacovigilance

New for 2022

Live online, Classroom
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: 16-17 Nov 2022 Live online
  • Also: 23-26 Jan 2023 Live online
  • Also: 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: 21-23 Nov 2022 Live online
  • Also: 22-24 Mar 2023 Live online
  • Also: 3-5 May 2023 Classroom
  • Also: 2-4 Oct 2023 Live online

Pharmacovigilance for Drug Safety, Regulatory Affairs and PV Auditors

New for 2022

Live online, Classroom
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: 29-30 Nov 2022 Live online
  • Also: 17-18 Apr 2023 Live online
  • Also: 3-4 Jul 2023 Classroom
  • Also: 14-17 Nov 2023 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: 1 Dec 2022 Live online
  • Also: 1 Jun 2023 Classroom
  • Also: 1 Dec 2023 Live online

An Essential Overview of Medical Information

Live online, Classroom
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: 7-9 Dec 2022 Classroom
  • Also: 29-31 Mar 2023 Live online
  • Also: 7-9 Jun 2023 Classroom
  • + 2 more

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: 20 Jan 2023 Live online
  • Also: 27-28 Apr 2023 Live online
  • Also: 25 Jul 2023 Live online
  • Also: 3 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: 31 Jan 2023 Live online
  • Also: 18 May 2023 Classroom
  • Also: 11-12 Sep 2023 Live online

An Essential Overview of Pharmacovigilance

Live online, Classroom
Focused

A practical guide to understanding the role of pharmacovigilance.

  • 6 CPD hours
  • Presented by Dr Graeme Ladds
  • Next: 17 Mar 2023 Live online
  • Also: 12 Jul 2023 Classroom
  • Also: 29-30 Nov 2023 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
  • Next: 26-27 Apr 2023 Live online
  • Also: 19-20 Oct 2023 Live online

Practical Requirements of the Arab Pharmacovigilance Guidelines

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: 19 Jan 2023 Live online
  • Also: 20-21 Apr 2023 Live online
  • Also: 24 Jul 2023 Live online
  • Also: 2 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