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APV/IPEC Europe Excipient Conference 2017  | CN 3177

– An update on regulatory and application developments 19.09. - 20.09.2017 | Berlin, Germany

Venue

Hotel Riu Plaza Berlin
Martin-Luther-Straße 1
10777 Berlin

Dear Colleagues,

IPEC Europe and APV are delighted to invite you to our 6th annual conference on pharmaceutical excipients.

The conference will focus on “hot topics” in the area of excipient regulation and technology. In contrast to the market for finished drugs and active pharmaceutical ingredients the market for excipients is extremely difficult to quantify. For the first time one lecture of the conference will provide an overview of the global excipients market with the focus on oral solid dosage forms.

As part of the 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 data integrity in excipient manufacture and supply chain, quality agreements and stability testing of excipients.

Beyond that the regulatory session will highlight the multifaceted challenges to ensure excipient compliance such as multi-compendial compliance of excipients, excipient packaging systems and excipient supply chain. How to verify that excipient suppliers work in compliance with the regulations and the transport of excipients will be reviewed too.

The technical and scientific part of the conference will deal with important excipient functionalities such as diluents for direct compression, the role of excipients in inhalation drugs and transdermal drug delivery. Further topics will be the requirements of excipients for continuous manufacturing processes and the impact that excipient grades have on the bioequivalence of generic drugs.

Last but not least 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.

We are looking forward to welcoming you in Berlin.

Table top Presentation / Sponsoring Options

As well as in the last years, we are offering you the opportunity to present your company, products and services to a truly focused target market. Here you can reach everyone dealing with excipients without wastage.

We are offering a tabletop for 995 Euro (excl. VAT) + one mandatory full conference registration. Space is limited, and applications will be dealt with on a ”first come, first served” basis.

A tabletop includes:

  • one table
  • two chairs
  • electricity
  • power supplies

Please download here:

For more information please contact Antonia Herbert.

Workshop programme for download

Description

including 3 parallel workshops:

  • Data Integrity – How to apply in excipient manufacture and supply chain
  • Quality Agreements – A simple story!?
  • Stability testing of Excipients – The IPEC Excipient Stability Program Guide (2010)

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:

  • Data integrity in excipient manufacture and supply chain
  • The new IPEC Quality Agreement Guide
  • Appropriate stability testing using the IPEC Stability Program Guide
  • Challenges of multi-compendial compliance for excipients
  • Quality requirements for excipient packaging systems
  • Challenges in a complex excipient supply chain – recent considerations
  • Verification of excipient supplier compliance
  • A commercial view: Overview of the global excipient market
  • Formulation topics

    • Diluents for direct compression
    • Continuous manufacturing – excipient requirements
    • Capsules – filling, interaction of formulation/excipients and release profiles of different capsule polymers
    • Transdermal drug delivery: An industrial viewpoint
    • Role of excipients in inhalation drug products
    • ICH Q3D implementation by the European Pharmacopoeia

Registration fee

  30.06.2017 01.07.2017
Industry 1,490.00 € 1,590.00 €
Authorities 745.00 € 795.00 €
All prices plus VAT(19.00% VAT)

Organizer(s)

APV GmbH

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