3rd Quarterly Update 2011

This quarter we have welcomed a new consultant within our team: Elvira Graat, who joined us as of August 1. She has previous experience as a safety-data manager in a Clinical Research Organization (CRO). Subsequently she worked as a Safety Data Specialist in a major pharmaceutical company being responsible for processing and entering adverse event information into the safety database and guaranteeing high levels of data quality and integrity. We look forward to her contribution to the pharmacovigiliance section of our team in the years to come .

This quarter we came to an agreement with an Asian pharmaceutical company regarding our regulatory support to their European expansion. This support will include running Decentralized Procedures (DCP’s) to get marketing authorizations for their generic products in various EU countries and will also include marketing- authorization-holdership, as well as responsibilities for the EU-release, distribution and pharmacovigilance of these generics. Thanks to our standing contracts with a certified pharmaceutical quality control laboratory and a GDP-approved logistic company we are able to provide these services instantaneously. We currently face increasing interest for this EU Market Access Program from countries all over the world, including Asia, USA, Canada and Mexico.

As of July 2012 the European requirements for pharmacovigilance will change significantly and one of these changes refers to the interfacing of the Eudravigilance database and local databases in pharmaceutical companies. One of our clients already has decided to get into the right lane and has asked us to support them with the updating of the datasets of all marketing authorizations. Simple as it seems, it appears that many entries in the old database are incomplete and incorrect, turning this project into a Regulatory Remediation Project rather than a straightforward database transfer. It clearly demonstrates the increasing complexity of the drug regulatory domain over the last decades.