Inspection Ready Consulting, Austrian Qualified Person Association (aqpa)
Dr Alexander Bachmann
ATB Pharma Innovation
Dr. Thomas Becker
Dr. Thomas Becker Pharma & Biotech Consulting
Dr Lenka Taylor
University Hospital of Heidelberg
Ian Holloway
former GMP/GCP/GDP Inspector at MHRA
Gerlinde Schmitter
CureVac
Note: All times mentioned are CET.
Objectives
During this Live Online Training Course, well-experienced specialists will share their expert knowledge about important aspects of IMP Supplies and the Management of Clinical Trials. Hear essential aspects about the organisation and management of the supplies, their distribution, things to consider during the study and learn how the various regulations lead the way. During this event, the important interfaces between GMP and GCP will be elaborated.
Background
In the development of new pharmaceutical products, it is a challenge to design and initiate sound and appropriate studies. Compliance with GMP and GCP regulations is mandatory. A prerequisite for a successful study is the thorough planning of the clinical trial supplies. Beginning with the order, the manufacturing and supply of the IMPs, an efficient study management and full compliance with applicable rules and regulations will lead to satisfactory results. GMP and GCP requirements need to be considered and understood from all parties involved.
Since 31 January 2022, the Clinical Trials Regulation 536/2014 (CTR) is applicable. This is followed by a consecutive Transition period of three years, during which both the contents of the CTR and the previous legislation on clinical trials will apply. Trials outside the EU and contracts and agreements are two other aspects which require particular attention. Especially, in regard of trials performed in UK after the Brexit.
This Live Online Training Course has been designed by the ECA to enhance and broaden your knowledge and to consolidate the various aspects which need to be considered for an efficient management of clinical Trials.
Target Group
Specialists, managers and executives from R&D dealing with the various aspects of IMP supply and clinical trial management. It addresses representatives from IMP manufacturing, packaging, QP certification and supply as well as from the study design and management and the respective Quality Assurance units. It is also directed to CROs and members of inspectorates and authorities.
Technical Requirements
We use Webex for our live online training courses and webinars. At https://www.gmp-compliance.org/training/onlinetraining-technical-information you will find all the Information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary Installation is fast and easy.
Testimonials
Seminar Programme as PDF