| what we have done so far | |||
| 2008 | |||
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Hexvix (hexaminolevulinate), an innovative agent for the detection of superficial bladder cancer, is reimbursed in Belgium as from 1/5/08 on. Furthermore Hexvix is excluded from the hospital forfait and this makes MPI’s success complete. Convincing the Commission to vote in favor of this class I reimbursement application required the construction of a sophisticated pharmaco-economics model, a well-balanced scientific argumentation and even a hearing.
Reimbursement in Belgium of Nexavar (sorafenib) has now been extended to patients with advanced hepatocellulair cancer, yet another successful application handled by MPI... |
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| 2007 | |||
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MPI managed to bring down the Belgian VAT on brachytherapy products from 21% to 6% and saved a small company over € 1 million in VAT, fines and interests. You wonder how that was done? Ask Us
Pack Insert Readability testing is now done in English, French and in Dutch. MPI signs an agreement as member of the users commission for the Tetra-project ABOP with the Antwerp and Ghent Institutes for Higher Education. The goal of this project is the development of an automated tool for the optimalisation of pack insert texts. DaTSCAN reimbursement in Belgium was revised by the Commission for the Reimbursement of Medicinal products; the modalities remain unchanged. Have a look at the European Journal of Nuclear Medicine and Molecular Imaging of 2 April 2008 for the pharmaco-economic model used to support the dossier. REACH: As a fairly small consultancy company, we cannot offer the “whole registration package from A to Z”, but we are able to help those companies which are struggling to define their role in the REACH game, with finding the right strategy on how to implement REACH, with setting up questionnaires for downstream users and/or suppliers, with filling in these questionnaires, and with meeting all different obligations. |
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| 2006 | |||
| This year only 2 orphan medical products are admitted to the Belgian reimbursement system; both dossiers have been managed by MPI. | |||
| A new service is launched: Pack insert readability testing in Dutch and in French. | |||
| MPI is now capable to prepare and submit fully compliant eCTD dossiers. | |||
We have seen an increased demand for our medical and
technical writing services:
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| 2005 | |||
| 6 entire registration dossiers have been converted to CTD format. | |||
| This year there was a major update of our computer system with the installation of a new server with improved security features (backup systems, protection against viruses, worms and trojans...) | |||
| Renewal of our alarm system. | |||
| April 2004 | |||
| MPI books a major success for Amerham Health in Belgium by obtaining Class I reimbursement for DaTSCAN (product with a proven phamaco-economical plus value). | |||
| March 2004 | |||
| DigitalRAM is launched! DigitalRAM is a total regulatory affairs solution for pharmaceutical & para-pharmaceutical companies. | |||
| October 2003 | |||
| MPI edits the 100th preclinical and clinical overview for drug registration purposes in Europe ! As the transition phase for conversion to the CTD format is now over, all MRP submissions should from now on comply with the new format. Talk to us if you wish to convert your older dossiers to meet the new requirements. | |||
| September 2003 | |||
| Opening of our new Armstraat offices, the spacious premises will allow us to serve our customers better. | |||
| December 2002 | |||
| MPI is now offering interim Regulatory Affairs management to compensate for the maternity / sick leave of one of a pharmaceutical companies’ Regulatory Affairs Officers. It is an immediate success! Feel free to contact us if you are confronted with similar within your company. | |||
| November 2002 | |||
| Good Distribution Practices for investigational medicinal products (project started March 2002) have now been implemented successfully. | |||
| August 2002 | |||
| The office in the J. Lemmenslaan is getting too cramped, making further growth of the business and expansion of the current staff impossible. We’ll start looking for a suitable alternative location. | |||
| March 2002 | |||
| MPI starts the process of implementation of Good Distribution Practices for investigational medicinal products within the premises of a medium sized pharmaceutical company. | |||
| January 2002 | |||
| An emerging innovative pharmaceutical company has requested us to provide support in the development of a revolutionary hormone-releasing IUD. We will have to provide guidance through virtually all development phases. | |||
| November 2001 | |||
| The medical writing services offered by MPI are greatly appreciated; the 50th preclinical and clinical expert report on drugs has just been finalised, numerous Periodic Safety Update Reports have been edited for our clients. | |||
| December 2000 | |||
| The first year has been difficult but business is growing steadily: several clients have already found their way to our door. | |||
| December 1999 | |||
| MPI enters the Clinical Research market and provides monitoring services on a limited scale, clients will be assisted in drafting protocols, case record forms, investigator’s brochures and other trial related materials. | |||
| November 1999 | |||
| Good Distribution Practices have been implemented in two independent companies specialized in international medicinal product trade. | |||
| July 1999 | |||
| Registration of MPI: the company will offer Medical Writing as well as Regulatory Affairs services in the EC | |||
| a list, containing the documents recently prepared by MPI, is available on request | |||
| (only the EC-type documents are listed) | |||
| z | regulatory affairs | pre-clinical and clinical expert reports | â ask list | |
| z | regulatory affairs | periodic safety update reports | â ask list | |
| z | request your free sample copy of a clinical export report | â ask sample | |
| the extensive clinical research experience is proven by the activities list | â look at list | ||