Topics to be covered will include:-
The new Pharmacovigilance Legislation of 2012 now requires companies to provide Risk Management Plans (RMPs) and assessments for all new products whether those products are generic products or new chemical entities. If these are not done correctly this can delay both licensure and sales and damage the Company ability to maximise its products. Maintenance of the RMPs also is an important aspect for maintaining the licence, compliance and these are reviewed in Regulatory Inspections. Can you afford not to get this right?
This course will be relevant for anyone requiring a comprehensive overview of the Pharmacovigilance function and duties. It may be of particular interest to those who are responsible in Pharmacovigilance for any safety assessments and writing such plans including any Medical Directors who approve such plans. Those who work with pharmacovigilance, e.g. Regulatory Affairs, Clinical, Sales & Marketing, Legal, Commercial and Quality and EU QP PVs that must sign off such documents.
09.00 Registration and Coffee
09.30 Meeting begins
An Introduction to EU RMPs – Production & Maintenance
Documentation to be Supplied to Regulatory Authorities – the process for RMPs
The EU Templates & their Completion – Generic and Innovator Products Including RMPs in other Countries
Practical – Completion of Sections I – III
Practical – Completion of Sections IV – VI
Practical – Completion of Annexes
17.00 Meeting ends
Graeme Ladds (29 Jan 2018)
Graeme Ladds, Director of PharSafer, has over 26 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.