IPEC e-newsletter - Excipients Insight March 2018 - 28-03-18

 

Inside this issue

     

Editorial

Hello, Excipients Insight readers,

As the first quarter of 2018 comes to a close, I’m glad to report that while we have set in place our plans for this year, many activities are ongoing. After our annual event in Bordeaux, we’ve had our first ‘outing’ to present the association at Europe’s First Making Pharmaceuticals event in Brussels earlier this month. IPEC Europe contributed to the speaker programme through Dr Liz Meehan and Astrid Stockrahm-Uhling, to whom we offer our thanks for spreading the word on excipient developments. We also had a stand at the exhibition which is a great opportunity to meet industry colleagues and the pharmaceutical press. This conference is already well-established in the UK and is being held on 24-25 April at the Ricoh Arena in Coventry. IPEC Europe will be there both as part of the exhibition and we will have three presenters. So if you missed us in Brussels, try to catch up with us there - registration is free. As I mention often, the possibility to have face-to-face interactions with our members, or indeed anyone with an interest in excipients, is always a privilege and is a great way to keep in touch with how we can keep moving our association forward.

And of course, the regulatory world always keeps us busy! There are several features in this edition which I’d like to mention. It seems there is always something to report from China and this month is no exception. The restructuring of the drug agency in China involves separating food from the drugs division. While our colleagues at IPEC China think this will have little impact on drug regulatory processes themselves, it is hoped that a period of stability can be expected. However, we do closely monitor China as it is such a dynamic country and we will continue to report happenings, as and when they occur.

In this issue you will find an article on the new guide issued on GXP data integrity issued by the UK’s MHRA. This is still one of the most talked about subjects and it remains one of the IPEC Federation’s priorities to develop a position paper on this topic. We very much hope that this will help to inform our audience as to what are reasonable expectations for data integrity in the excipient ’world’. One of our main objectives continues to be that we must ensure that excipients and their unique nature are fully considered when viewed relative to new expectations. I am sure we will be coming back to this topic many times throughout the year. 

And finally, I’d like to ask for your help. As we try to re-establish our objectives related to compendial review and harmonisation, to inform a meeting which will be held in April, your assistance in completing this survey will help us greatly in determining our strategy for the future. We repeatedly hear that harmonisation is important to IPEC so here is your - or a colleague's - chance to let us know. We look forward to hearing from you!

Until next time,

 

Frithjof Holtz

IPEC Europe chair

 

 

 

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