Graeme Ladds

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

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

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

In this one-day course, understand everything from the role of medical information to the guidelines for medical information and advertising.

A practical guide to understanding the role of pharmacovigilance.

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.

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.

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

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.

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 ten years.

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