Dr Rango Dietrich, PharmDev Innovations
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the coming into force of the CTR, the currently valid GMP guidelines for IMPs as well as the current Annex 13 will be repealed.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.
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
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