2nd Quarterly Update 2007
This quarter we celebrated the 20th anniversary of our company by spending a marvellous weekend in Istanbul with all team members and their partners. We enjoyed the views from a boat trip on the Bosporus and paid visits to most of the famous architectural beauties of this city. Turkish hospitality provided for lots of good food in various nice restaurants in the city and of course we paid a visit to the Grand Bazaar where some of us spent money on “nice things to have” or got chased by stallholders in case they didn’t. But as all things must come to an end we returned home to find out that it is again “business as usual”.
Not quite usual, however, is the start of a new team member this quarter. Maria Caspers joined our team as of June 1 and she brings with her considerable experience with the implementation and (lead-)auditing of ISO-9002 and HACCP systems in quite a number of companies. In addition to this there is sufficient familiarity with the quality requirements applicable to the manufacture and distribution of medicinal products and medical devices. We are convinced she will significantly contribute to the activities of our team while at the same time acquainting herself with the domain of regulatory affairs.
Over the last years some of us got that much acquainted with this field that one of us was asked to act as interim Director RA in a leading generic company in the Netherlands. Due to a maternity leave this position, involving the coaching of a team of RA-managers and –officers, will be held until August. This colleague, who has seen quite a number of RA-departments in various pharmaceutical companies, will be ideally equipped to contribute to the smooth and efficient processing of marketing authorization applications (and their variations) in this department.
An exotic project this quarter is the auditing of the drug distribution and storage in a cosmetic surgery clinic. This type of clinic is under considerable surveillance by the health authorities due to a number of recent incidents and this audit indeed was ordered by the Inspectorate following a site visit. Quite interesting it is to get introduced in the world of botox, liposuction, breast correction and dental restructuring. Indeed the audit revealed a number of necessary corrective actions as well as recommendations to improve the management of pharmaceuticals and medical devices in this facility and to upgrade this to a level which is common to regular hospitals.
