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.
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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
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This programme will be of interest to all personnel involved in business development and licensing agreements aspects of pharmacovigilance
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Understand the relationship between RMPs and safety reviews; PBRERs/DSURs; licence submissions (CTD) and their maintenance.
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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.
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A practical guide to understanding the role of pharmacovigilance.
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An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.
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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.
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This course is designed to help understand pharmacovigilance quality management systems (QMS) and risk-based audits.
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.
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.
Updated for 2023
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Practical guidance on how to comply with the pharmacovigilance requirements in the Middle East
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.
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
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