recorded on 13.11.2019
|Non-ECA Members:||EUR 249,--|
|ECA Members:||EUR 199,--|
(All prices excl. VAT)
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You will learn about the new requirements for manufacturing, labelling, testing, release and distribution of investigational medicinal products (IMPs) and get to know different aspects of the outstanding changes in the EU and in Germany.
The Clinical Trials Regulation No 536/2014 (CTR) entered into force in 2014. The date of its initial application depends on the full functionality of the Clinical Trials Information System (CTIS) being established by an independent audit. Right now, preparations for the CTIS’ audit are being made. The CTR will become applicable six month after the publication of this confirmation by the European Commission.
With the coming into force of the CTR, the currently valid GMP guidelines for IMPs as well as the current Annex 13 will be repealed. Various customary provisions for IMPs (e.g. Labelling, import, sponsor responsibility, safety reporting) have been revised, partly with considerable consequences regarding the time and budget for clinical trial supplying. The resulting changes in the handling of IMPs will be introduced in this webinar. It will also throw light on the newly regulated comparator products and non-IMPs (NIMPs) which are used as background therapy in clinical trials.
This training is aimed at all workers in the pharmaceutical industry involved in the development, manufacturing, quality control, packaging, quality assurance, release and distribution of IMPS, as well as persons from authorities and associations. It also addresses employees of IMP contract manufacturers and staff at CROs who are involved in the project planning for provisioning IMPs.
Changes of regulatory requirements due to Regulation (EU) No 536/2014 on clinical trials for human medicines (CTR) and the repealing of Directive 2001/20/EC
Regulation (EU) 536/2014 (CTR) and associated Delegated Regulations and guidelines
Major changes in comparison with GMP Directive 2003/94/EC, Annex 13 of the EU GMP Guidelines and Directive 2001/20/EC
Sponsor responsibility in IMP release, distribution and agreements on limitations of liability
Perceived loopholes and pain points
Labelling according to Annex VI of the CTR
Major changes in comparison with Annex 13 and challenges of Annex VI
Possible solutions to the challenges of Annex VI
Comparators and auxiliary medicinal products (AxMPs)
Use of comparators and AxMPs in clinical trials
Changes due to Regulation (EU) 536/2014 (CTR)
Imports from third countries
Imports from third countries (i.e. drug substance, drug product, IMP); changes due to Regulation (EU) 536/2014 (CTR)
Mutual recognition agreement (MRA)
Qualifying suppliers in the supply chain
The role of the QP
Dr Rango Dietrich, PharmDev Innovations
Dr Rango Dietrich is CEO of PharmDev Innovations and Qualified Person as per §14 AMG. He has worked in the pharmaceutical industry, at Byk Gulden GmbH (later Altana Pharma AG), for over twenty years. As a company executive, he had full responsibility for the global pharmaceutical development there. Since 2007, he has been working as a consultant for the pharmaceutical industry, covering the topics pharmaceutical development and investigational medicinal products