Every year, European countries celebrate European Organ Donation Day (EODD). The idea behind this Day, initiated by the Council of Europe, is to encourage debate and provide information on organ, tissues and cells donation and transplantation, and legal and medical measures so that every European can decide about donation and make their wishes known to their family. Organ, tissues and cells transplantation is one of the great medical success stories of modern times and is the only life-saving treatment for end-stage organ failure in many conditions.
The Procedure of Certification of Suitability to the Monographs of the European Pharmacopoeia (CEP) is an important tool for regulators and industry in preparing, assessing and managing marketing authorisations for medicinal products. The aim of this conference is to trace recent evolutions and changes of the Certification Procedure in a fast moving regulatory environment.
The software has been developed at the EDQM and can perform calculations according to Chapter 5.3 of the European Pharmacopoeia (5th Edition to 9th Edition). The primary objective of this training session is to provide insights into the main functionalities proposed in the CombiStats™ software, illustrated with demonstrations of the tool. The programme will focus on the practical use of the software in a variety of situations. Each session will include examples and exercises.
The EDQM will hold an international symposium on 10-11 October 2017 in Strasbourg (France) to present and discuss recent achievements, as well as future perspectives, of the Ph. Eur. in the microbiology field. The programme will cover, among others, topics such as Rapid Microbiology Methods (RMMs), including specific sessions on pharmaceutical water and cell therapy preparations, methods of preparation of sterile products and Biological Indicators (BIs) used in the manufacture of sterile products.
During this conference, speakers from authorities, inspectorate bodies, blood establishments and suppliers will provide you with information about the current regulatory requirements and present their knowledge and practical experience in the field of qualification, validation, change management and risk management
From 24 to 26 October, the EDQM will be exhibiting at CPhI Worldwide which will take place in Frankfurt, Germany. Meet us at 41K80 to learn more about the European Pharmacopoeia, our latest publications (9th Edition), what new products will be coming out in the months ahead and the comprehensive range of services we offer.
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 EDQM will be participating at CPhI India which will take place in Mumbai at the Bombay Exhibition Centre. Visit our stand D65 to learn more about the European Pharmacopoeia, our latest publications, what new products will be coming out in the months ahead and the comprehensive range of services we offer.