|Email Newsletters from Pharmaceutical Technology and Pharmaceutical Technology Europe|
News from Europe's pharmaceutical manufacturing industry coupled with upcoming events, and exclusive articles and interviews from industry experts.
NPOs lead the way at CPhI
Another very busy day at CPhI Worldwide and co-located events with good meetings in every corner for all exhibitors.
If you missed yesterday's blog, the winner of the Innovation Awards was Glycotope for its GlycoExpress platform technology, which optimised glycosylation of antibodies and other biotherapeutics. The award was received by a very proud and happy Jens Pohl, managing director on Oct. 25, 2011.
In other news, UBM Live announced its plans for ICSE USA, which will debut at the Pennsylvania Convention Centre in Philadelphia and run from May 22-23, 2012. Apparently, 60.2 % of ICSE Europe visitors indicated that North America is the main target for business development, and ICSE USA seeks to address this trend. "ICSE USA's introduction, in conjunction with Pharmapack North America, EAST Pack and MD&M is a win-win across the board. The combined events offer a platform for US companies that are working to address the upcoming blockbuster drugs [patent] expirations to connect with global business contacts and partner with and vice versa," said Haf Cennyd, brand director of ICSE in UBM's Show Daily magazine.
RX-360 in 2012
Giving examples of potentially adulterated acetonitrile and the effects of the tsunami and subsequent radiation leaks in Japan earlier this year, one of RX-360's aims is to provide early identification of issues followed by rapid response, disseminating information through the website and social media channels at virtually no cost.
RX-360 has recently concluded its Audit Pilot, which aims to improve efficiency in the system through two routes. Sharing of redacted supplier audits through a secure database is the first, with joint audits offering further opportunities; sponsor companies can plan ahead through RX-360 and request joint audits to be conducted by a vetted third party auditor. The audit campaign will be rolled in 2012, and is particularly relevant as the Falsified Medicines Directive (FMD) will make it mandatory to conduct audits of all API suppliers every three years.
EXCiPACT - International Pharmaceutical Excipients Certification
Finally, Guy Villax graced the stage for a second time on behalf of EFCG, this time to talk about the FDA's proposed Generic Drug User Fee Act (GDUFA, seemingly pronounced ger-doo-fer), which seeks to raise funds of $299 million for FDA "to allow the FDA to do their job on a global scale." This means, from the Vilax' point of view, that FDA will be able to accelerate the approval process, promote faster access to lower-cost, higher-quality medicines, and level the playing field―all major steps forward for generics. Watch this space for news and upcoming information.
Thank you for reading, and see you in Madrid in 2012!