IPEC e-newsletter - Excipients Insight June 2010 - 30-06-10


Inside this issue


Word of the Chair

Hello everyone.  Time flies don't you agree?  It was not very long ago when we met in Cannes to build upon last year's learnings, to carefully plan how we address this year's challenges and achieve our objectives.  Now summer is here and we continue to pursue our goals and strive hard to deliver our commitments to the regulatory authorities and industry partners.  

The IPEC-PDG meeting in June, in Tallinn, Estonia was a very constructive forum which enabled knowledge exchange among the participants.  This invaluable exercise enabled us to continue our efforts in contributing to the ongoing harmonisation program.  For the first time, we were officially represented as IPEC Federation during this event.  Check out the news from the Harmonisation Committee which provides a good summary of milestones of the recent pharmacopoeial discussions.

For many of you who are closely following the developments on the proposed Directive on Falsified Medicines, you have the Board's reassurance of relentless and sustained efforts to represent our views and support for this regulatory proposal.  We continue to contribute and offer our expertise in order to assist the authorities to formulate a Directive that truly ensures the safety and quality of medicines.  The article update [here] reflects the current state-of-play of our advocacy work on this subject.  Additionally, we have initiated the very first webinar to provide first-hand information on this hot topic to interested members.  Several sessions are planned in the coming months to enable a more interactive forum.

Excipact - our Certification Project - is moving along at a healthy pace.  A business plan is being put in place in order to define the delivery mechanism to the industry.  Efforts are being undertaken to compare the GMP and GDP guidelines to ensure a more coherent language, the scheme rules are being updated and a package being put together for review by members of IPEC.  Once in circulation, I encourage you all to peruse these materials and provide your feedback to the Excipact Team.

The Quality and Regulatory Affairs Committee has also just sent you all the QbD survey.  I hope you found time to send in your responses. If not, please do so and send in your contributions back to IPEC.  This will help us to continuously enhance our QbD aid document and, hopefully, ease our ability to implement Quality by Design.

The next six months will be a hectic time for everyone but should be nonetheless exciting.  We will do our utmost to keep the momentum going and ensure that your voice is continuously heard in the industry.  

I wish you all a warm and energizing summer!

Cheers all,





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