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: 1 Mar 2024 Live online
  • Also: 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 Dr Graeme Ladds
  • Next: 15 Mar 2024 Live online
  • Also: 11 Jul 2024 Live online
  • Also: 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: 18-19 Mar 2024 Live online
  • Also: 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: 16 Apr 2024 Live online
  • Also: 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: 24 Apr 2024 Live online
  • Also: 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: 8-10 May 2024 Live online
  • Also: 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 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 Focused
  • Presented by Dr Graeme Ladds
  • Next: 16 May 2024 Live online
  • Also: 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: 20-21 May 2024 Live online
  • Also: 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: 20-22 Mar 2024 Live online
  • Also: 5-7 Jun 2024 Classroom
  • Also: 18-20 Sep 2024 Live online
  • Also: 9-13 Dec 2024 Live online

Advanced Pharmacovigilance

Live online, Classroom

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: 20-21 Jun 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: 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: 13-14 Jun 2024 Live online
  • Also: 17-18 Oct 2024 Live online

Practical Requirements of the Arab Pharmacovigilance Guidelines

Updated for 2024

Live online

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

  • 12 CPD hours Focused
  • Presented by Dr Graeme Ladds