IPEC e-newsletter - Excipients Insight June/July 2017 - 10-07-17

 

Inside this issue

     

Editorial

Dear colleagues,

Welcome to my first editorial since I succeeded as chair of IPEC Europe in this double edition of Excipients Insight as we head in to the summer vacation period.

As always, many things are happening and it was fortunate that the IPEC Europe Board met in Brussels at the end of June as it was a great opportunity for us to take stock of where we are with our objectives and agree plans for the remainder of 2017.

We have achieved some significant goals in the first half of this year, including the official launch of two of our most significant guides (covering excipient GMP and GDP), three new members joined us, we held a webinar on GDP, and we presented and exhibited at two major industry symposia recently in Italy (AFI) and the UK (Making Pharmaceuticals). Of course, the greatest benefit of all of these events is that we are expanding our reach, spreading the word on excipients, their role and why specific guidance is needed, which is nicely aligned with our mission. As you can see from the calendar in this edition, this continues throughout the year. In September we’ll be attending PowTech 2017 on Powder and Bulk solids in Nuremberg and the APV/IPEC Europe Conference in Berlin. And as we have other guidance documents ready for release, such as the new CoProcessed Excipients Guide and the revised Quality Agreements guide, there’ll be a lot more information to share, so don’t hesitate to come and visit us if you’re there.

One recent development on which I’m very pleased to report is that IPEC Europe is now on the European Medicines Agency’s (EMA) list of eligible stakeholders. Again, this will help to establish a platform at the regulatory level in Europe for important excipient issues. We’ll share more details of how this process works as we learn more but, however this transpires, this is a great step forward for IPEC Europe. Equally, our increased engagement with other associations such as APIC and EFCG promotes good debate on thought-provoking issues of common interest and helps focus our agenda. Your ideas are always welcome and, as an example, members have again raised the subject of excipient master files in Europe. As China has now indicated that it agrees with this philosophy, maybe it’s time again to tackle this in IPEC Europe. What do you think? As ever, if you feel there are areas uncovered you like us to address, let us know.

Meanwhile, please enjoy this edition and here’s hoping you all make the most of the summer months ahead!

 

Frithjof Holtz

Chair of IPEC Europe

 

 

 

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