Since 2016 ARS has provided a full range of pharmacovigilance services in accordance with the requirements of GVP of the EEU:

  Providing a 24/7 hotline

  Pharmacovigilance trainings

  Processing of ICSR at the territory of the Russian Federation (signal management, collection, validation, medical assessment, reporting)

  Maintenance of a database of Individual Case Safety Report (ICSR)

  Scientific and medical literature and other source screening to detect spontaneous safety reports

  Submission of Periodic Safety Update Report (PSUR) to the Regulatory authorities

  Monitoring the benefit-risk ratio

  Developing of risk management plans

OUR COMPETITIVE ADVANTAGES:

6

Years of experience in this field

80+

Periodic Safety Update Reports and Development Safety Update Reports

CONTACTS

Russia, Moscow.

Multifanctional complex «Federation»
Presnenskaya embankment, 12
East Tower, 27th floor, 17 room.

© ARS PHARMRUSSIA: CLINICAL & REGULATORY EXPERT CRO, 2009-2024
All rights reserved.