Challenge

Provide a full project management and regulatory function for a Centralised MAA for a virtual pharmaceutical company.

Approach

The EUDRAC team project managed, wrote or reviewed and published the MAA according to the client’s deadline.  A MS Project plan was developed for the preparation of the MAA and the subsequent assessment process to ensure transparency to the virtual team of their responsibilities and timelines.  People in the EUDRAC team had responsibility for different areas of the MAA in order that they had an in depth knowledge of the product.  EUDRAC was the contact point with EMA.  Successful presubmission meetings were held with EMA, the Rapporteur and the Co-Rapporteur.  Validation occurred with minimal questions.  At time of draft assessment report, strategies were already discussed as to how to answer the questions when they were officially posed at Day 120 and a clarification meeting held with the Rapporteur and the Co-Rapporteur to ensure the proposed response strategies would be acceptable.  The product information was developed based upon regulatory precedent but also to ensure key data that would subsequently be used in the promotion of the product was included.

Conclusion

The product received its marketing authorisation and the client was subsequently able to transfer this to a larger pharmaceutical company who could support a European launch of the product (achieving milestone payments and royalties).  The client continues to work with EUDRAC on other projects for over 7 years.