This quarter we were facing significant changes within our team as both Susil Chotoe and Ivan Utama decided to leave our company in pursuit of new career options within pharmaceutical companies. We very much regret such changes as these represent a loss of experience and client-specific knowledge. However, we were fortunate in finding appropriate replacement represented by dr. Jacobine van Houts – Kuijlaars and Max Robben M.Sc. The latter will take over pharmacovigilance responsibilities while Jacobine will dedicate herself to the regulatory affairs projects.
Still we need additional QP – resources in order to cope with the massive demand for support in EU supply chain redesign we are now facing. Only this quarter we got 5 requests from global pharmaceutical companies currently busy with such redesigning. Manufacturing responsibilities and wholesale responsibilities need to be demarcated, the flow of goods needs to be differentiated from the financial flow, the site of EU-release needs to be defined and the appropriates licenses for each site should be applied for. We also frequently encounter law firms in such projects who got lost in the woods and ultimately realize this is not “legal stuff” but can only be done with extensive pharmaceutical regulatory experience on board.
One of those projects gave our colleague Jasper Vink the possibility to become our auditing record-holder after he went to China to audit 5 manufacturing sites in one week. Likewise, this project itself also became a champion with respect to the number of audits per project as a total of 13 audits, including those 5 in China, need to be performed to cover the entire manufacturing and distribution chain. The essential ones have been done by now but a few are still planned in 2018. What do you think, would this project be eligible for the Guinness Book of Records?