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Manjit Virdee

GSK, UK

Manjit has twenty years of experience in Pharmacovigilance working both in industry and for a regulatory authority. He worked in the global safety groups at Roche and Amgen between 2001 – 2007 which gave him a good understanding of day to day case handling activities and how this impacts periodic reporting and signal detection. Manjit joined the MHRA as a Pharmacovigilance inspector in 2007 and conducted over one hundred inspections of a diverse range of companies. During his time at the MHRA he was involved in writing the Good Pharmacovigilance Practice guide and producing inspection metrics reports for the MHRA website. He also had the opportunity to interact with inspectors from many other EU agencies and presented on behalf of the MHRA at many symposia and conferences. In 2013 he joined GSKs PV audit group where he has been responsible for conducting audits of local operating companies, licensing partners and service providers (e.g. patient support programme (PSP) and market research (MR) vendors). He has also been heavily involved in managing regulatory authority inspections and audits from licensing partners. He is responsible for risk assessing PSP, MR and digital media vendors for the GSK annual audit programme.

 


Abstract

Challenges of Collecting Safety Data from Commercial Activities

Manjit Virdee (GSK, United Kingdom) Technology is allowing pharmaceutical companies to interact with patients and prescribers through multiple channels which are managed by marketing and commercial functions. It can be challenging to implement systems to capture relevant safety information from these activities. The legislation and guidance in this area has not necessarily kept pace with changing technologies and does not give clear direction.  

The presentation will review:

  • What the current legislation and guidance say about commercial activities
  • The methods by which pharmaceutical companies can interact with their patients and prescribers (e.g. patient support programmes, market research studies, digital media activities)
  • The challenges and value of collecting safety data from commercial activities
  • Approaches to risk assessing vendors conducting commercial activities
  • What should be reviewed on audits and examples of issues that can be identified.

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