IPEC e-newsletter - Excipients Insight January 2018 - 20-01-18

 

Inside this issue

     

Looking ahead to the 2018 Annual Excipients Forum

On February 1, IPEC Europe will host its Annual Excipients Forum, a key date in the calendar for all involved in the supply, distribution and use of pharmaceutical excipients, Bordeaux.

We’re delighted to announce that the final version of the programme includes a presentation on the latest developments in China, and in particular a regulation on excipients – introduced briefly in the December 2017 edition of Excipients Insight – that introduces some fundamental changes to the way excipients are regulated. Mr Colin Li, Chair of IPEC China, has agreed to update delegates on these critical changes for companies operating in the Chinese pharma market.

That’s just the latest addition to what is a comprehensive and interesting programme for the annual seminar, picking up on some of the most pressing issues of the moment. There is still time for last-minute registrations if you would like to join us in Bordeaux, although the remaining seats are going fast so don't delay!

After opening comments from IPEC Europe chair Mr Frithjof Holtz, the first morning will feature a presentation from EDQM Director Dr Susanne Keitel on the draft General Monograph on Co-processed Excipients, along with other developments in the European Pharmacopoeia (Ph. Eur.) relevant to excipients, with the US perspective on co-processed excipients Mr Brian Carlin from IPEC-Americas.

After a break, Ms Catherin Sheehan of the US Pharmacopeia (USP) will cover the changes to the USP-NF excipient monographs and general chapters being carried out part as part of USP’s modernisation drive, as well as exploring harmonization opportunities between the compendium and its peers around the world – via the Pharmacopoeial Discussion Group (PDG). Dr

Dr Sabine Kopp of the World Health Organization will build on that topic with a talk on Good Pharmacopoeial Practices (GPP) as a facilitator for reduced duplication and greater convergence between pharmacopoeias.

Mr Li’s China presentation will kick off the session after lunch, and will be followed with a talk by Dr Yvonne Rosiaux of Gattefossé, who will examine how suppliers and users of excipients can work together on Quality by Design (QbD) projects – in theory and in practice – drawing on a specific case study.  That will be followed by presentations by Ms Elham Blouet of Roquette Frères on excipient attributes required for parenteral formulations – a particularly timely presentation given recent developments on GMP for sterile drugs at the WHO and ICH – and Ms Kate Coleman on risk assessment for GMP excipients, another hot topic.

Finally, after what will be a full day, there’ll be time to relax at an historical vineyard on the outskirts of Bordeaux. The Cocktail Reception and Forum Dinner will take place in the distinguished Château Smith Haut Lafitte, nestled in a 78-hectare estate surrounded by wonderful scenery. You will have the unique opportunity to visit the impressive Château’s cellars, where more than 1000 wine barrels 'rest' as they slowly mature to perfection!

Looking forward to seeing you in the fine city of Bordeaux!

 

 

 

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