Online training | Online
The training will focus on chemically defined substances and cover all the fundamentals related to the use of the European Pharmacopoeia and its reference standards, as well as the procedure for Certification of suitability to the monographs of the European Pharmacopoeia (CEP).
Transplantation / Tissue | Online training | 13 September 2021 to 15 October 2021 | online
The course covers the fundamental aspects of biovigilance in the field of tissues and cells and provides guidance on how to ensure accurate and harmonised information is submitted to the annual EU SARE exercise.
Certification of suitability (CEP) / Procedure of certification (general) | Online training | 28 September 2021 | Strasbourg, France
This webinar is for holders of a Certificate of Suitability to the European Pharmacopoeia (CEP). Experienced EDQM CEP Assessors will explain how to maintain a CEP once it has been granted. Advice will be given on what to include in a revision application with a view to obtaining rapid acceptance of the proposed changes.
European Pharmacopoeia / CombiStats TM | Online training | 05 October 2021 to 07 October 2021 | Strasbourg, France
The CombiStats™ software was developed at the EDQM to perform calculations according to chapter 5.3 of the European Pharmacopoeia (5th Edition to 10th Edition). The primary objective of these webinars is to provide insights into the main functionalities of the CombiStats™ software, which will be illustrated with demonstrations of the tool.
Transplantation / Tissue | Online training | 20 October 2021 to 25 November 2021 | online
Tissue establishments implement a quality management system (QMS) to ensure that tissues and cells consistently comply with technical and legal requirements; this QMS must cover all aspects of the activities undertaken by the tissue establishment. During the last decade, many sector developments have led to continuous changes in the organisation of tissue establishments and in their approaches to ensuring safety and quality. The concept of quality management (QM) has also greatly evolved within this field and, consequently, tissue establishments have had to continually adapt to new requirements.