Date: Thursday 19 March 2015
Time : 9.30 am – 10.30 am and 3.30 pm-4.30 pm (CET)
Duration: 60 minutes each
The 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:
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.
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.
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.
9-10 July 2015
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!
If you have any queries about registering or require further information, please contact the EDQM's Public Relations via the EDQM HelpDesk.