IPEC e-newsletter - Excipients Insight June 2015 - 30-06-15


Inside this issue


Mark your diary! APV/IPEC Europe Excipient Conference 2015

IPEC Europe and APV are delighted to invite you once again to our annual conference on pharmaceutical excipients, which will take place in Barcelona, Spain on 23-24 September. As in previous years the conference will focus on “hot topics” in the area of excipient regulation and technology.

Along with a comprehensive and thought-provoking conference programme we will offer three parallel workshops to provide practical, hands-on insight and discussion on pressing regulatory topics, with a view to developing joint solutions. These workshops will focus on change management, risk management and quality agreements, topics which will have a lot of impact on the pharmaceutical industry and suppliers alike.

This year’s regulatory session will highlight the new ICH Q3D guideline on elemental impurities and the changes to EU GMP Guidelines Part 1 (chapter 5) which will create a lot of work for industry in the future. Different views will be presented and discussed from a European perspective, and we will also look at developments on the other side of the Atlantic and discuss the impact of new US regulation on the supply of excipients.

The technical and scientific part of the conference will be opened with a compendial topic presented by EDQM. All other presentations in this session will focus on the role of excipients and their function in dosage forms.

With this program we tried to gather different aspects of excipients and combine regulatory and technical topics as they are the two sides of one coin.

Once again, networking and exchange of information is a key feature of the event and table-top exhibitions aligned to the conference will encourage communication between suppliers and users as well.

We hope you will agree that the topics covered include some really pressing issues affecting excipients, and we are looking forward to welcoming you in Barcelona.


This event is designed to highlight current hot topics in the field of pharmaceutical excipients:

• Change management of excipients
• Risk assessment for excipient GMP
• Quality agreements for excipients
• ICH Q3D - Elemental Impurities
• New supplier qualification requirements in the EU
• Impact of FDASIA and GDUFA on excipient use in the US
• New developments/trends in
        o Capsule shell materials
        o Orodispersible dosage forms
        o Transdermal patches
        o Recombinant human serum albumin as excipient
        o Functional characterization of excipients
        o High purity excipient considerations
        o And more

For more details and registration information, click here




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