IPEC e-newsletter - Excipients Insight November/December 2014 - 05-12-14


Inside this issue


Word of the Chair

Dear IPEC Europe members,

This is the last edition of Excipients Insight for 2014, which was a milestone year for IPEC Europe as we finalised the move of our association from France to Belgium. The French structure has been dissolved and IPEC Europe is now solely based in Brussels. Since July, we have been operating an independent office in Brussels with two employees working exclusively for IPEC Europe. As a result, we have significantly more personnel resources to support the activities of the association and generate more activities in the future.

We organised and supported three events around excipients this year: our annual seminar in January in Cannes, ExcipientFest Europe held in June in Amsterdam and the IPEC/APV Excipient Conference in Düsseldorf in September. All events provided useful platforms to table hot topics for our industry and gave the opportunity to exchange regulatory and scientific information. For next year we are already planning an excipient forum aligned to our AGM in Nice on 5. February 2015. The programme is set and registration is open. Furthermore, we will continue collaboration with APV and arrange another open conference in Barcelona on 23 and 24 September 2015. Please save that date; further information will be available soon.

Looking back at the key events in 2014, we see some interesting regulatory changes like the revision of chapter 5 of EU GMP Part 1 - which has an important impact on our industry - and are expecting the final Risk Assessment Guide for Excipient GMP of the EU early in 2015.

Meanwhile, we completed some key IPEC projects such as the revision of the IPEC Significant Change Guide which will be published soon. Next year, new projects are waiting for us, like the revision of the IPEC PQG GMP Guide and the development of a risk management guide for excipients aligned to the new EU regulation for excipient GMP.

We intensified the relationship with our friends of IPEC Americas, IPEC Japan and IPEC China over the year and clear objectives have been jointly defined for our global umbrella association, IPEC Federation, for 2015.

I hope that all of you are looking back on a successful and productive 2014, and I thank all contributors to our various IPEC Europe projects and activities.

A special thanks to our new employees Carole Capitaine and Sarah Anhorn, for setting up our new Brussels office with no interruption of service.

I wish you all a peaceful Christmas time and a healthy and prosperous 2015. I hope to see you all in Nice early February!

Kind regards


Dr. Frank Milek
Chairman of IPEC Europe





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