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European Pharmacopoeia Online Webinar

NEW: Join our Webinars "Biologicals of the twenty-PhEur-st century"

Date: Thursday 19 March 2015

Time : 9.30 am – 10.30 am and 3.30 pm-4.30 pm (CET)

Duration: 60 minutes each

Language: English

Programme Overview

DCEP webinarThe European Pharmacopoeia (Ph. Eur.) provides public standards for the quality of medicinal products and their constituents which are legally binding in Europe.

The Ph. Eur. began elaborating monographs on biologicals in the 70s, starting with vaccines and then moving on to include substances extracted from animal tissues, blood products and biotech products.

 

To continue to meet the needs of users, Ph. Eur. texts must reflect changes not only in the range of medicines available on the market but also in the regulatory framework and guidance (e.g. the concept of biosimilars and the ICH Q8/Q9/Q10 guidelines). The aim of this webinar is to show how the Ph. Eur. embraces these developments, how it has adapted its texts to remain up to date with recent advances in science and medical practice and the challenges that remain ahead.

 

The presentations will cover the following topics:

 

  • Brief introduction to the Ph. Eur.
  • How monographs and general chapters are elaborated
  • Overview of the main texts dealing with biologicals, with a specific focus on biotech products (role of general chapters, general monographs and specific monographs)
  • The flexibility provided by the Ph. Eur., including examples of QbD approaches for biologicals
  • The Ph. Eur. and biosimilars, with examples of how their development is being fostered
  • Update on the current work programme and hot topics in the field of biotech product monographs

 

The webinar will be provided by Dr Emmanuelle Charton, Head of Division in the European Pharmacopoeia Department. Her division is in charge of the elaboration and revision of European Pharmacopoeia texts related to biologicals, radiopharmaceuticals and microbiology.

 

Who should attend

This webinar will be of interest to professionals working on biologicals in national regulatory agencies, regulatory affairs, manufacturing, pharmaceutical or biological analysis as well as in quality control / compliance.

 

System Requirements

No special software is necessary for the webinar. If you wish to connect to audio using VoIP (Voice over Internet Protocol) you will need a fast Internet connection, a microphone and speakers. A USB headset is recommended. The VoIP connection is free. You are strongly advised to consult your IT Department to ensure your computer can receive the webinar.

 

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 Registration Fees

 

The Registration Fee is 150 EUR per delegate.

 

Participation is free of charge for EDQM experts and permanent staff of national licensing authorities and pharmacopoeias.


Places are limited, so sign up today!



How to Register

 

  • Register Online!

 After registration you will receive an invitation telling you how to access the webinar and  to test the system beforehand. On the day of the webinar, click on the link in the registration confirmation email.


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Before registering, read:
Terms of Supply for EDQM Events

 


More Information

If you have any queries about registering or require further information, please contact the EDQM's Public Relations via the EDQM HelpDesk.

 

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