The objective of these FOUR FREE WEBINAR SESSIONS is to enable participants to expand their knowledge and familiarise themselves with the work and procedures of the European Pharmacopoeia (Ph. Eur.) and related activities of the EDQM.
Webinar 1: General Concepts & Methods
This webinar will give participants 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. It will also cover the Ph. Eur. General Methods and present concrete examples on using and interpreting these texts.
- Webinar 2: European Pharmacopoeia Monographs
This session will focus on Specific Monographs on substances for pharmaceutical use and on Finished Products (containing chemically defined APIs) in the European Pharmacopoeia.
- Webinar 3: Ph. Eur. Reference Standards & Databases
Participants will be given an outline of how Ph. Eur. Reference Standards are established and used for impurity control, system suitability, peak identification and for quantification of related substances. It will also cover practical aspects such as the handling and dispatch of reference standards as well as getting the most from the EDQM’s databases and tips using its online publications (e.g. Knowledge, Pharmeuropa and Ph. Eur. Online).
- Webinar 4: CEP Procedure & Inspections
This webinar will focus on the Procedure for Certification of Suitability (CEP) to the Monographs of the European Pharmacopoeia and its inspection programme. The webinar is designed to clarify and improve holders and users’ understanding of the content of a CEP. Topics include the aim and scope of a CEP, how to interpret the information laid down in a CEP, the update of CEPs after revisions and renewals, and a summary of deficiencies and common problems encountered during evaluations and some practical advice on how to avoid them.
Ample time has been scheduled in each webinar session for question and answer sessions. The webinars will be recorded and the link to watch the recording sent to registered participants afterwards. Participants can register for as many sessions as they wish, based on their interests and learning needs.
Download the detailed programme
Who should attend?
These webinars are of interest to those interested or working in development, production, quality control, compliance and regulatory affairs. They may also be of interest to manufacturers of chemically-defined substances for pharmaceutical use who are interested in applying for CEP’s, who deal already with CEP applications or that would like to better understand the basis of the evaluations performed by the EDQM.
Send us your questions in advance
Do not miss this opportunity to ask everything you always wanted to know about the EDQM, the European Pharmacopoeia and the CEP Procedure.
Registered webinar participants are invited to submit their questions in advance using the question form below. It will also be possible to send us questions during the webinars, 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.
If you would like to submit a question in advance, please complete the Question form and send it to the Public Relations Division. For organisational reasons, these questions should be submitted not later than 1 July.
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 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.