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DESCRIPTION:The pharmacovigilance system master file (PSMF) is a legal req
 uirement for any medicinal product authorised in the European Union. The 
 PSMF provides the regulators with a detailed description and assessment o
 f the entire pharmacovigilance system and the outputs contained in the an
 nexes provide an understanding of a company’s compliance. This course wil
 l provide a practical guide to planning\, writing\, maintaining and updat
 ing the PSMF to ensure compliance. The programme will cover the importanc
 e of the PSMF in regulatory inspections\, including common PSMF inspectio
 n findings. You will discuss the processes and systems required to manage
  the PSMF as well as the latest advice on the impact of Brexit.\n\nBenefi
 ts of attending:\n\n\nUnderstand the regulatory requirements for the PSMF
 \nGain an overview of the key issues in producing\, maintaining and updat
 ing the PSMF\nDiscuss the PSMF as a QMS document\nLearn about the roles o
 f the QPPV and the PSMF\nReview common inspection findings and deficienci
 es related to the PSMF\n
DTEND:20210129T163000
DTSTAMP:20260512T213554Z
DTSTART:20210129T090000
LOCATION:\,
SEQUENCE:0
SUMMARY:The pharmacovigilance system master file (PSMF) is a legal require
 ment for any medicinal product authorised in the European Union. The PSMF
  provide...
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