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Updated requirements for pharmacovigilance contact person at national level in EU (LCPPV)

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March 24, 2021

It is difficult to get clear information about the requirements…

Targeted Adverse Event Questionnaires

February 21, 2021

Pharmacovigilance System Master File

February 20, 2021

The MHRA has issued guidance on the QPPV for UK authorised products

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January 29, 2021

For all UK MAs, including those that cover the whole of the…

Interested in Steen Ottosen ApS

Steen Ottosen ApS

Experts with extensive experience in Global Pharmacovigilance as well as clinical medicine are available to support pharmaceutical industry and national competent authorities

Services

Strategic advice for medicines authorization filings and regulator queries
Development and management of a pharmacovigilance function
Medical Monitoring
Medical Drug Safety Operations
Data cleaning and data review
Risk Management Plans
Regulatory intelligence
QPPV (Qualified Person for Pharmacovigilance)

PSMF (Pharmacovigilance System Master File)
Maintaining EU article 57 database, SPOR system, EVDAS and Eudravigilance database
Regulatory intelligence
Literature search
Regulatory compliance
Standard Operating Procedures
Signal Detection
Inspection Support
Auditing