Webinar Series on Impurities: European Pharmacopoeia Activities on Elemental Impurities and Nitrosamines
Tuesday, 30 June 2020 14.00 - 15.30 h
Course No. 18175
Speakers
Dr. Ulrich Rose
Straßburg
Important: Deadline is 12 noon on 29 June 2020You will find all webinars of this series in this overview
Background
In September 2019 EMA published documents which request Marketing Authorisation Holders (MAHs) to evaluate the risk of the presence of Nitrosamine impurities in human medicinal products containing chemically synthesised APIs. In case of contamination with Nitrosamines which requires critical changes in the manufacture of drug substances and drug products MAHs have to file a variation application. All regulatory activities with regard to such cases have to be completed within a 3 years period (end of March 2022). Contamination with Elemental Impurities (EIs) in drug products is a critical case as well. The ICH Q3D Guideline outlines PDE values for EIs and requests controls designed to limit their presence in Drug Products to levels at or below the PDE. As both Nitrosamines and EIs are of particular concern in pharmaceutical products European Pharmacopoeia policies had to be amended which led to the revision of a number of monographs.
Target Group
The webinar addresses all personnel involved in development of drug substances and drug products from scientific staff to laboratory heads involved in R&D. The needs of Laboratory Managers, Supervisors and Analysts in pharmaceutical quality assurance and quality control departments will also be covered. This event will also address regulatory requirements and hence is applicable to people working in the regulatory affairs area.
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.
In this webinar you will get an update of European Pharmacopoeia activities around mutagenic impurities with focus on Nitrosamines and Elemental Impurities. You will be informed about
how the control of Nitrosamines is reflected in the Ph. Eur.
the changes in the individual and general monographs of the Ph. Eur.
what has to be considered regarding the new general chapter on control of nitrosamines
how ICH Q3D has been implemented in the Ph. Eur.
the second phase for revision of excipient monographs
A representative of EDQM will explain the recent initiatives with respect to drug substance monographs of the Ph. Eur.
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Testimonials
Seminar Programme as PDF