IPEC e-newsletter - Excipients Insight November/December 2015 - 21-12-15


Inside this issue


Word of the Chair

Dear colleagues,
The end of the year is fast approaching, and you are probably preparing to share time with your family during the forthcoming holiday season whilst no doubt wondering at how quickly 2015 flashed by.

This is a good time to look back and review the past year. For IPEC Europe, 2015 was once again a turbulent year as the association tackled objectives and tasks that were both expected and unexpected. Nevertheless, we can look back to some good achievements.

The board has continued to increase IPEC Europe's efficiency by improving our way of collaborating, to work hand to hand with our sister associations –IPEC Federation and EXCiPACT - and to represent the association towards stakeholders. We had great support in that from our office in Brussels which has now been operational for 18 months.

IPEC Europe's committees and task forces are working relentlessly to provide the excipients community with tools to better guarantee excipients' quality and patients' safety. In collaboration with IPEC Americas and PQG, IPEC Europe has been revising the Quality Agreement Guide that should be finalised by mid-2016. A GMP Task Force has been formed and is already starting to contribute to the revision of the IPEC PQG GMP Guide. Meanwhile, the GDP Committee has started work on a new edition of the IPEC GDP guide and is contributing to the ongoing revision of the WHO GTDP guide.

The Risk Assessment task force has developed a draft of a 'how-to' document to help not only pharmaceutical companies but also suppliers implement the EU Guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients (OJ2015/C 95/02). Soon the document will be shared for comments with the IPEC Europe membership and other stakeholders, and we anticipate it will be ready for publication in early 2016.

We also organised two successful conferences in Nice and Barcelona this year with more than 200 participants in total. Many more activities happened during the year and these will be reported at our annual meeting in early February 2016. On behalf of the IPEC Europe board I would like to thank all contributors to our projects.

I would also like to remind you of our annual Excipients Forum that will be held in Nice on 4 February. The theme for the 2016 event is "Minimizing Risk, Maximizing Quality to Maintain Patient Safety". It is being held as always in combination with our Annual General Meeting, which will take place on 5 February. For more information about the programme and registration visit our website. I am looking forward to meeting you all there.
Wishing you a pleasant holiday season and a healthy and prosperous 2016.
Kind regards
Frank Milek




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