Live Online Training - How to write the Quality Part of an IMPD
8/9 December 2020
Course No. 18433
Speakers
Dr Wolfram Eisenreich
Boehringer Ingelheim Pharma
Dr. Jörg Engelbergs
Paul-Ehrlich-Institut
Objectives
This Live Online Training highlights the key principles of the Quality Part of an IMPD for Investigational Medicinal Products, both of chemical and biotechnological origin. You will get to know the essential aspects relevant for compiling the IMPD Quality Part and you will learn
How to prepare and process the quality related information for drug substance and drug product
How to manage and document changes concerning quality data
How to consider quality parameters of drug substance and drug product with potential clinical relevance
How to describe the manufacturing process development for a biotech IMP
How to process and document stability data for an IMPD of a biotech product
Background
An IMPD is required for every Investigational Medicinal Product (IMP) to be used in a clinical study, regardless of whether it is the test product itself, a reference product already authorised or a placebo. The IMPD includes summaries of information related to the quality, manufacture and control of the IMP as well as data from non-clinical and clinical studies. Furthermore, it contains an overall risk-benefit assessment and critical analyses of the non-clinical and clinical data related to the potential risks and benefits of the proposed study.
In March 2006 the CHMP “Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation concerning Investigational Medicinal Products in Clinical Trials” was published in Chapter III of Volume 10 of EudraLex.
Another CHMP Guidance for Biologicals entitled “Guideline on the Requirements for Quality Documentation concerning Biological Investigational Medicinal Products in Clinical Trials” was adopted in March 2012 and became effective in April 2012.
Target Group
This Live Online Training is designed for all persons involved in the compilation of IMPDs who want to become familiar with the requirements for the quality documentation of investigational medicinal products. The training will be of interest in particular for personnel from Regulatory Affairs as well as for personnel from Quality Assurance, Quality Control and Production.
Technical Requirements
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://www.webex.com/test-meeting.html 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.
To find alternative dates for this training/webinar or similar events please see the complete list of all events.
For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.
Testimonials
Seminar Programme as PDF