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REGISTRATION OPEN! European Pharmacopoeia Workshop on 10-11 September 2019

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European Pharmacopoeia
Workshop
10 September 2019 to 11 September 2019
Iselin, New Jersey (USA)

Venue: Renaissance Woodbridge Hotel, 515 US Highway 1 South, Iselin, NJ 08830

Working Language: English

Programme Overview

The programme has been designed to enable participants to expand their knowledge and familiarise themselves with the work and procedures of the European Pharmacopoeia and related activities of the EDQM.

The programme covers:

  • An overview of the European regulatory framework, the role of the EDQM and the European Pharmacopoeia at a European and international level, including international harmonisation activities;
  • Practical advice on using and interpreting the European Pharmacopoeia General Chapters, what is new and what has been revised;
  • An outline of how European Pharmacopoeia Reference Standards are established and used for impurity control, system suitability, peak identification and for quantification of related substances;
  • A closer look at Specific Monographs on Finished Product and Biotherapeutics in the European Pharmacopoeia;
  • An insight into what the European Pharmacopoeia is doing to foster the implementation of new technologies and Continuous Manufacturing;
  • An overview of the Procedure for Certification of Suitability to the Monographs of the European Pharmacopoeia, including its inspection programme;
  • Workshop draft programme (subject to change).

 

Who should attend?

This workshop is of interest to those interested or working in development, production, quality control and regulatory affairs.

 

Submit your questions in advance

Participants are invited to submit theirquestions in advance using the Question Form below. We will collect your questions and deliver them to the EDQM speakers beforehand, in order to give them some time to prepare the answers.

We will also take questions during the workshop, but submitting them in advance will help us focus on the topics that generate the most interest. We cannot promise to answer every question, but all questions are welcome and encouraged.

Do not miss this wonderful opportunity to ask everything you always wanted to know about the EDQM and the European Pharmacopoeia.

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