Time: 10:00 am - 11:30 am CET (Paris)
Duration: about 60 minutes + 30 minutes for questions
The aim of this webinar is to explain the context of the elaboration of the new European Pharmacopoeia (Ph. Eur.) general chapter Raw materials of biological origin for the production of cell-based and gene therapy medicinal products and its scope. The first part of the webinar will give an introduction to the Ph. Eur. and its place within the EU regulatory network. The second part will be dedicated to the general chapter 5.2.12 and will provide information on the context of its elaboration followed by an overview of the chapter and the class of raw materials of biological origin covered.
The webinar will be provided by Dr Jaana Vesterinen, Finnish Medicines Agency (Fimea) and Chair of the Ph. Eur. Group of Experts on RCG, and Dr Céline Pugieux-Amarantos, Scientific Officer in the European Pharmacopoeia Dept., EDQM/Council of Europe.
Who should attend?
This webinar will be of interest to professionals working in the quality control, development, and manufacture of biologicals, cell-based and gene therapy medicinal products.
Prior to the webinar you have the possibility to use a question form to submit general questions which you would like to have addressed in the webinar. Due to organisational reasons, these questions should be submitted not later than
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 and that the following domain name are neither rejected nor blocked as spam, otherwise you will not receive the link to connect to the webinar: @gotowebinar.com and @care.gotowebinar.com.