Following the release of the EDQM guideline “Implementation of ICH Q3D in the Certification Procedure” (PA/PH/CEP (16) 23) in August of this year, the EDQM will host a FREE webinar on Tuesday 16th May 2017.
This event will be especially significant as the EDQM will present its latest edition of the Guide to the Preparation, Use and Quality Assurance of Blood Components (18th Edition).
The EDQM will be participating at CPhI China which will take place in Shanghai at the Shanghai New International Expo Centre (SNIEC). Meet us at stand E1A19 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.
The programme has been designed to enable participants to expand their knowledge and familiarise themselves with the work and procedures of the European Pharmacopoeia.
The need for organ transplants is increasing worldwide. The on-going lack of available organs has resulted in an increase in the number of patients on the waiting list. In 2015, in the European Union (EU) countries, 100,000 people were waiting for organ donations. Each day, on average, 11 people died while waiting for a transplant.
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 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.
More information will be published shortly.