4th Quarterly update 2008

This quarter we have become Council Partner of the Gerson Lehrman Group (www.glgroup.com). This group concerns a worldwide consulting management platform currently including over 200,000 experts covering quite a few business domains. We were invited to participate with the Healthcare Group thanks to our overall knowledge of, and experience with, European and Dutch pharmaceutical issues. Likewise, some clients already could benefit from our more general overview of the Dutch healthcare system. All our senior consultants now have entered this fascinating area of high-level consulting.

However, our day-to-day operations keep on requiring our devotion and this particularly applies to our Pharmacovigilance System which is now in the process of finalizing. Our current and future reponsibilities as European Qualified Person for Pharmacovigilance (QPPV) obliges us to have such a system in place which is fully compliant with the EU Volume 9A of the Rules Governing Medicinal Products in the EU. While our clients also include companies which operate outside the EU, particular attention should be paid to the merging of these EU and non-EU vigilance activities. So, each of these companies will require a separate interfacing SOP as well as a mutual responsibility matrix. In addition, to serve as the contact point for the EMEA and the competent authorities of the various member states, access to the EudraVigilance system has been obtained.

More European regulations have crossed our path this quarter as one of our colleagues has got involved in the design of a multi-centre European clinical study involving various countries. Apart from this study design, clinical trial applications (CTA’s) should be submitted in all member states involved, requiring detailed knowledge of the relevant national regulations. For these details we gratefully consult our respective colleagues from the Eudracon network (www.eudracon.com). Time and time again such projects prove that pharmaceutical regulatory consulting requires cross-border cooperation just as much as competent authorities and medicines evaluation boards (MEB’s) need such cooperation.

But sometimes, finishing cooperation is what you aim for and that is the case with a Mutual Recognition Procedure (MRP) to be finalized this month (today being Day 88). This MRP, including a generic antibiotic, involved 5 member states and again required extensive cross-border cooperation with regulatory affairs professionals in the various member states involved. But, not uncommon to MRP’s, the sting is in the tail as one MEB submitted 15 (!) detailed questions regarding the drug substance only on Day 87….. It will be a great relief when this comes to an end next week enabling us to send the long-awaited marketing authorizations to our client. What better Christmas present is there to receive in our profession?