IPEC e-newsletter - Excipients Insight September 2016 - 30-09-16


Inside this issue



Dear IPEC Europe members,

This edition of Excipients Insight comes to you hoping you had a most agreeable summer break.  But 'excipient work is never done', to paraphrase a well-known saying and we are now very engaged in preparing for our remaining events in 2016 and 2017 activities.

IPEC Europe and APV's Fifth annual conference on pharmaceutical excipients was held on 20 and 21 September in Prague. The agenda included many "hot topics" in the area of excipient regulation and technology so expect a report in our next issue of Excipients Insights. We run these forums to help deliver on our mission's promise to inform and exchange good practices, hopefully to help you meet regulatory expectations in the most efficient manner. Please give us your feedback on how well we are doing. It's very much appreciated.

Pivotal to IPEC Europe's future direction is our 'Agenda 2020' which is being actively worked on by your Board, not least to facilitate planning and budgeting for 2017. The roadmap which supports our longer term vision is effectively our strategic plan, which will be presented to the membership at our next Annual General Meeting (2 February 2017), which this year will be held at the Hermitage Hotel in Monte Carlo, Monaco. The programmes for this and our annual Excipient Forum (1 February 2017) are being finalised by our event committee. This new and special location has been chosen as 2017 is a very significant year for IPEC Europe, as it marks our 25th anniversary. The registration website will open in October and full details will be available soon. Mark the dates in your calendar!

On the regulatory front, two topics which are very much under discussion are China, specifically the so-called new China 'bundling' excipient regulations, and elemental impurities which, continues to generate a lot of 'noise'! Our last Excipients Insight presented a summary of the China regulations. We're now working with our IPEC colleagues in China to clarify various points and later will circulate a summary of these to our membership. Before the summer break, IPEC Europe was fortunate to host representatives of China's National Institutes for Food and Drug Control (NIFDC, a subordinate agency of the China Food and Drug Administration) where we discussed how we may collaborate in future. Gaining a better understanding of each other regulatory processes is something which will feature heavily in this programme. More details in our next edition. Meanwhile, please don't hesitate to submit to your Secretariat any questions you have on this new regulatory process. We have another opportunity in October to engage with Chinese regulatory officers as IPEC Europe was invited to be a panellist on the forthcoming EDQM/ChP Workshop in Strasbourg (17 October).

And last but not least I am very pleased to announce that IPEC Europe will be presenting its inaugural webinar on one of the most talked about subjects of the moment, GMP risk assessment for excipients! A webinar programme is very much in line with IPEC Europe’s direction to reach out to our members and beyond, on subjects with a European focus. Our première will be on 24 November and all being well we are hoping to run several more in 2017. For this first occasion while registration will be free, places will be limited. Watch out for registration details.

Also in this issue, please look out for the PRQI collaborative study on elemental impurities, which will help to inform the debate on acceptable testing methodologies.

There's a lot going on. So until the next time, and if you have any newsworthy items to share, please get in touch!
Frank Milek

IPEC Europe, President




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