IPEC e-newsletter - Excipients Insight April 2017 - 30-04-17


Inside this issue


Interview: Departing chair Frank Milek looks back on past five years

After five years at the helm, IPEC Europe chair Frank Milek is stepping down, to be succeeded by the current vice chair, Frithjof Holtz.

In this last edition of Excipients Insight to be published during his tenure, we asked Frank to look back on his time leading the association and give some pointers for the future.

EI: When you took over as chair of IPEC Europe in 2012 – what did you see as the biggest challenges for the association, and what was your vision for taking it forward?

FM: When I took over the chairmanship the primary objective was to restructure the operations of the association. At the time it was registered in France, with administrative support from an external provider based in Brussels, and IPEC Europe relied heavily on volunteers from the membership. One of my main goals was to move the registration to Brussels, to benefit from close proximity to EU policymaking mechanisms and also to tap into some financial advantages unavailable in France. It was important to me that IPEC Europe should have its own office and secretariat, staffed with its own dedicated personnel. It is worse noting also that six of the eight IPEC Europe board members changed as I took over as chair. That presented some challenges in terms of continuity, but also gave us the opportunity to start fresh.

EI: What do you see as the most important changes that have taken place in the operating environment for excipient suppliers and users in the intervening years, and how successful has IPEC Europe been in responding to those changes?

FM: We had some significant regulatory changes in terms of risk-assessment and GMP for excipients – which is now required –as well as some changes relating to the relationship between excipient suppliers and users, such as a requirement for formal quality agreements. These have been a challenge for both suppliers and users.  I believe however that IPEC Europe responded effectively to that through our strong support of the EXCiPACT standard and third-party certification system – which allows better qualification of excipient suppliers and save resources on both sides – and of course A huge amount of work has gone into updating our guidelines to facilitate compliance. Revisions of the IPEC-PQG GMP Guide and GDP Guide, which were first prepared in 2006, are just about to be published, and we have also published recently the Significant Change Guide, the Quality Agreement Guide and a How-To Document for Risk assessment. Of course, that body of work drew on the excellent and close cooperation between IPEC Europe, our sister PECs and the IPEC Federation. These fruitful working relationships have also helped tackle another big challenge facing the industry over the last few years – globalization - which has added to the array of standards and regulations affecting excipients.

EI: How would you describe your legacy at the association, and what improvements could still be made?

FM: From my perspective, the biggest achievement is to leave my successor with an association that in part because of the structural changes – now registered and location in Belgium and with a growing secretariat staff – is better positioned to monitor and react quickly to new developments affecting pharmaceutical excipients. Along with two full-time employees to provide administrative and organisational support, IPEC Europe can now draw upon the expertise of Adrian Bone, senior advisor to the association, so that the projects undertaken by the association no longer all have to be done only by volunteers.  I really wanted to put all these changes into effect before stepping down, and that is one reason why I have served for five years – one of the longest tenures of any IPEC Europe chair. Expanding the network of experts such as Adrian remains a priority, to assist volunteers so that more practical work can be carried out by the association and it can respond even faster to regulatory challenges when required. It would also be desirable to increase cooperation with other stakeholders – for example other industry associations like APIC, EFCG and EFPIA – raise our visibility with regulatory authorities and also embrace newer communication channels such as social media.

EI: As IPEC Europe embarks on a new era, do you have any words for the incoming chair of the association?

I am delighted that Frithjof will be taking over as chair of IPEC Europe, as he has many years of experience as a board member of the association and has been intimately involved in setting and working on our objectives, including our recently-drafted Agenda 2020. I know that he is committed to continuing the invaluable work of IPEC Europe and I have no doubt that he will receive the same excellent level of support from the rest of the board and the membership that I have enjoyed over the last five years.




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