This course provides a comprehensive 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.
The course intends to show how the safety of products is managed at the regulatory authority level, the interactions with regulatory bodies and pharma, and the internal pharma processes in managing the safety of the company products. From receiving safety cases and information to signal analysis and safety communication, all of this is viewed from a practical point of view for compliance and Key Performance Indicators (KPIs).
The European Medicines Agency (EMA) and the Pharmacovigilance Risk Assessment Committee (PRAC) deliberations and the UK Brexit implications will be discussed.
Benefits of attending
- Explore how the safety of products is managed at the regulatory authority level, the interactions with regulatory bodies and pharma
- Learn the internal pharma processes in managing the safety of the company products from receiving safety cases/information, all the way through to signal analysis and safety communication
- Discuss The European Medicines Agency (EMA) and the Pharmacovigilance Risk Assessment Committee (PRAC) deliberations and Brexit implications
Certifications:
- CPD: 18 hours for your records
- Certificate of completion
Course Content
Day 1
Course Provider
Mr Graeme Ladds,
Director ,
PharSafer Associates Ltd.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.
Who Should Attend
This course is intended for senior management professionals from European and US pharmaceutical companies, who need to understand EU Pharmacovigilance. It will be particularly beneficial for those working in allied technical areas (regulatory, clinical, QA, and auditing) who require an overview of key pharmacovigilance activities and also need to understand the many complexities of EU pharmacovigilance, including the UK Brexit implications.
All of these activities are discussed in relation to Quality Management Systems (QMS), audits and inspections.
