Vigilance Training Courses

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.

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

A practical guide to understanding the role of pharmacovigilance.

Delve into the world of additional Risk Minimization Measures (aRMMs) and explore everything from the regulatory framework surrounding aRMMs to their impact on patient safety and healthcare outcomes.

Learn the essential regulatory requirements for post-market surveillance (PMS), post-market clinical follow-up (PMCF), and vigilance of digital health technologies, ensuring product safety, compliance, and continued value creation throughout the product lifecycle

This two-day course offers a thorough understanding of literature searching in drug safety, covering regulatory requirements, search criteria, and the interpretation of safety data, while also providing practical assessments to apply knowledge to real-world pharmacovigilance cases.

This two-day course covers international standards for clinical and post-marketing drug safety, including ICH guidelines, adverse event reporting, signal detection, and risk management strategies.

A comprehensive introductory guide to signal detection in pharmacovigilance, covering its history, regulations, processes, and safety assessments.

A comprehensive comparison between the importance Risk Evaluation and Mitigation Strategies (REMS) and Risk Management Plans (RMP) in drug safety.

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

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 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.

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

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.

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.

This course provides a foundation in the critical role of signal detection in ensuring the safety and efficacy of medicines.

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

This course provides an overview for senior managers of the key post-market pharmacovigilance activities required to further understand the 2012 EU legislation that has undergone over 20 updates in the last 10 years.

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.

In this exciting new course, gain an introduction into the transformative impact of artificial intelligence on drug safety and monitoring.

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.