Vigilance Training Courses

A Practical Guide to Producing and Maintaining the PSMF

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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.

A Practical Guide to Writing Risk Management Plans (RMPs)

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

Advanced Pharmacovigilance

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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.

Advanced Veterinary Pharmacovigilance

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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

An Essential Overview of Medical Information

Updated for 2023

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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

An Essential Overview of Pharmacovigilance

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A practical guide to understanding the role of pharmacovigilance.

Artificial Intelligence and Machine Learning Powered Signal Management

New for 2023

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This course will prepare you to navigate the multiverse of Artificial Intelligence (AI), Machine Learning (ML) and Deep Learning from a drug safety perspective with an easily understandable and practical approach.

Cosmetovigilance

Updated for 2023

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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.

European Post Marketing Pharmacovigilance - Including the EMA/PRAC deliberations and Brexit implications

New for 2023

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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.

Introduction to Veterinary Pharmacovigilance

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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*

Pharmacovigilance

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

Pharmacovigilance Aspects of Licensing Agreements

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

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

New for 2023

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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.

Pharmacovigilance QMS & Inspection Preparation

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

Practical Requirements of the Arab Pharmacovigilance Guidelines

Updated for 2023

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

Signal Detection and Regulatory Expectations

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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

Understanding Pharmacovigilance Regulations in APAC

New for 2023

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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.