Those of us involved in the supply, distribution and use of pharmaceutical excipients are experiencing what is arguably one of the most dramatic periods of regulatory change in years.
New legislation such as the Falsified Medicines Directive (FDA) in Europe and Food and Drug Administration Safety and Innovation Act (FDASIA) in the US are having an operational impact on our sector. It is therefore more important than ever to stay informed of developments - not just in our own region but also other areas of the world - so we can understand, anticipate and respond to evolving circumstances.
IPEC Europe has always tried to provide this insight to its membership via its annual seminar and other channels such as this newsletter, but is committed to stepping up its communication activities even further.
An integral part of that process is to support and participate in international conferences and exhibitions and IPEC Europe is therefore proud to be collaborating on two events in 2014, namely ExcipientFest Europe in Amsterdam, the Netherlands, on 24-June and the APV/IPEC Europe Excipient Conference in Düsseldorf, Germany, scheduled for 23-24 September.
At ExcipientFest Europe, IPEC Europe will be organising three workshop tracks on risk management, quality-by-design and auditing excipient suppliers, while representatives from our organisation will present on a plethora of topics, including Good Manufacturing Practice (GMP), Certificates of Analysis (CoA), auditing and excipient supplier certification (EXCiPACT) and change control, amongst others.
The APV/IPEC Europe Excipients Conference will review the regulatory environment in Europe, the US and emerging markets such as India, China and Brazil, cover topics on supply chain and excipient quality, functionality and applications, and will also feature a podium discussion on GMP compliance.
More information on both events, as well as registration links, is available on our website.