DUBLIN--(BUSINESS WIRE)--The "A Practical Guide to Producing and Maintaining the PSMF" conference has been added to ResearchAndMarkets.com's offering.
The pharmacovigilance legislation of 2012 requires companies to provide Risk Management Plans (RMPs) and assessments for all new products, whether generic products or new chemical entities.
The new pharmacovigilance legislation of 2012 now requires companies to provide a PSMF and that this document should be 'Inspections ready'. If this is not done correctly, this can result in critical findings for the Company that could set back further product launches or event sanctions against the Company existing products. Maintenance of the PSMF also is an important aspect for maintaining the Company compliance and these are reviewed in Regulatory Inspections. Can you afford not to get it right?
- Registration and Coffee
- An Introduction to PSMFs
- The Content of the PSMF
- The Sections of the PSMF
- The Annexe requirements for the PSMF
Close of Meeting
Graeme Ladds has over 22 years' experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, Graeme went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals.
The last 11 years have been spent in his consultancy company, PharSafer Associates Ltd. During this time, Graeme 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.
For more information about this conference visit https://www.researchandmarkets.com/research/7ph3t9/a_practical_guide?w=4