IPEC e-newsletter - Excipients Insight September 2015 - 30-09-15


Inside this issue


Word of the Chair

Dear readers,

This edition of Excipients Insight comes to you after a busy September that seems to have already made the summer a distant memory.

The highlight of the past month was IPEC Europe and APV's Excipient Conference, held on 23 and 24 September in Barcelona, Spain. For those of you who participated, you will doubtless recall not only the interesting programme and pleasant atmosphere of the city but also the unusual wake-up call on day two of the conference. A fire in the breakfast room of the conference hotel - fortunately quickly contained - reminded us of the critical need for risk assessment and a quality system programme!

Topics that were covered during the two-day event included ICH Q3D, global regulatory compliance, supply chain security and also scientific presentations covering subjects such as recombinant human serum albumin as an excipient and orodispersible tablets. With 90 delegates registered, the conference was a success and we hope you will join again next year. Keep an eye on our website and LinkedIn page to be informed about the next event.

In this edition, you will read about the Agenda 2020 put together by the board as a follow-up to the membership survey conducted earlier this year. The IPEC Europe board values members’ feedback and constantly works to meet their expectations. The Agenda 2020 will be followed by a roadmap with concrete actions and expected dates of completion.

Also, the IPEC Federation published its position paper on third party audit and certification. This is the second position statement this year after the document on risk assessment. As always, IPEC Europe collaborates with its sister associations to develop statement and guidance on global issues.

IPEC Europe's task forces are actively working on revisions to the Quality Agreement and the GMP Guide in collaboration with IPEC Americas as well as PQG in the latter case. Another team is developing a how-to guide to implement the EU guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use. The how-to guide should be ready by beginning of November. Finally a group is working on the ICH Q3D guidelines. If you are a member of IPEC Europe and interested in contributing, please do not hesitate to contact the secretariat.

Lastly, we will soon launch the registration to our annual Excipients Forum that will take place in Nice, France - once again in the prestigious Negresco Hotel on 4 February, 2016. The event committee is finalising the programme. Stay tuned to our website and LinkedIn page to know more.

All the best.

Frank Milek

IPEC Europe Chair




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