Date: 26 September 2018
Time: 10:00 am-11:00 am (CET, Paris)
Duration: 45 minutes + 15 minutes for questions
The objective of this live, interactive webinar is to present the changes in the acceptability and classification of some revisions described in the newly revised EDQM ‘Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia monographs’ which is expected to be published on the EDQM’s Certification web pages in the summer. There will also be a presentation on the revision process and good practices to help certificate holders gain rapid acceptance of their proposed changes.
The presentation will cover the following topics:
- Summary of the revision process.
- Recent changes in acceptability and classification of some revisions included in the revised guideline.
- Where to include supporting and revised documentation in the submitted file.
The webinar will be given by Ms Nataliia Mostrianska, Scientific Assistant, Mr Ciaran Feeney, Principal Scientific Assistant and Dr Andrew McMath, Head of Section for Revisions, Certification of Substances Department, EDQM, Council of Europe.
Who should attend
This webinar will be of interest to professionals working in regulatory affairs.
Participation is FREE OF CHARGE.
If you have any general questions which you would like to have addressed during the webinar, you may submit them via a question form prior to the webinar. For organisational reasons, these questions should be submitted not later than 14 September.
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 access the webinar and that the following domain names 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.