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APV/IPEC Europe Excipient Conference 2015  | CN 3144

An update on regulatory and application developments 23.09. - 24.09.2015 | Barcelona, Spain

Venue

Novotel Barcelona City
Avinguda Diagonal 201
08018 Barcelona
Phone:(+34) 9332 62499
Fax:(+34) 9332 08779

Dear Colleagues,

IPEC Europe and APV are delighted to invite you once again to our annual conference on pharmaceutical excipients. 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 providepractical, 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 GMPGuidelines Part 1 (chapter 5) which will create a lot of work for industry in the future. Different views will be presented anddiscussed from a European perspective, and we will also look at developments on the other side of the Atlantic and discuss theimpact 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 otherpresentations 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 thetwo 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 lookingforward to welcoming you in Barcelona.

Hubertus Folttmann
Board Member of IPEC Europe

Frank Milek
Chair to IPEC Europe

Workshop programme for download

Target groups

This conference is intended for professionals working in
• development, manufacture and quality
• distribution and sales
• qualification of suppliers
• application and control
of pharmaceutical excipients for medicinal products.
The seminar is also intended for members of regulatory authorities and purchasing departments.

Objective

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

Cooperation partner(s)

ipec EUROPE
ONdrugDelivery

Media Partner

Registration fee

  30.06.2015 01.07.2015
Regular Fee 1,490.00 € 1,590.00 €
Reduced Fee 1,360.00 € 1,460.00 €
All prices plus VAT

Organizer(s)

APV GmbH

Phone: +49 6131 97690
Fax: +49 6131 976969
E-mail: apv@apv-mainz.de
www: https://www.apv-mainz.de/apv/