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Safety Writing & Pharmacovigilance

Safety Writing/Pharmacovigilance has evolved to be a discipline of its own. With the new European GVP legislation both processes and documents become streamlined, which creates a need for professionally compiled and harmonized content. Utilising pooled resources from the Medical Writing and Pharmacovigilance departments, we have specialised in providing quality writing, consulting and editorial support services for the creation and maintenance of Pharmacovigilance documents. Our services cover pharmacovigilance in the pre- and post-marketing settings.

Safety Writing Services:
•    Development Safety Update Report (DSUR)
•    Periodic Safety Update Report (PSUR)
•    Periodic Benefit Risk Evaluation Reports (PBRER)
•    Risk Management Plan (RMP)
 
Pharmacovigilance Services:
•    Set-up & maintenance of validated safety databases
•    SAE/AE Reporting
•    Expedited Reporting
•    Monthly Line Listings
•    Medical Safety Reviews

Use of VigilanceOne (eDrug Safety Database):
•    Was developed in cooperation with the German regulatory authorities Paul-Ehrlich-Institut (PEI) and Bundesinstitut für Arzneimittel and
      Medizinprodukte (BfArM)
•    Compliant with ICH-E2B and requirements of regulatory authorities (e.g. BfArM/PEI/EMA)
•    Supports the E2B data exchange via the Eudravigilance gateway or other E2B compliant gateway interfaces
•    Offers exchange formats that guarantee efficient data exchange between VigilanceOne and external receivers and regulatory authorities

 

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