Webinar Series on Impurities: Mutagenic Impurities with Focus on Nitrosamines - What do Regulatory Authorities Expect

Webinar Series on Impurities: Mutagenic Impurities with Focus on Nitrosamines - What do Regulatory Authorities Expect

Course No 18176

Important: Deadline is 12.00 noon on 01 September 2020

You will find all webinars of this series in this overview
 

Costs

ECA-Member: EUR 199,--
Non ECA Member: EUR 249,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr Corina Nachtsheim, BfArM, Germany

Background

In June 2018 EU authorities were notified that a Chinese API manufacturer has detected the presence of N-nitrosodimethylamine, NDMA, in batches of Valsartan. Meanwhile different Nitrosamines (NDMA, NDEA and others) were detected in several drug products containing Sartan derivatives as an API. NDMA is a genotoxic and carcinogenic agent in animals and is classified as a Class 2A carcinogen to humans. Therefore Marketing Authorisation Holders are requested to evaluate the risk of the presence of Nitrosamine impurities in human medicinal products containing chemically synthesised APIs and to take immediate steps to avoid nitrosamines in human medicines. As a consequence in case of any contamination with mutagenic impurities Marketing Authorisation Holders have to file a variation application. All regulatory activities with regard to such cases have to be completed within a 3 years period.

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.

Programme

This webinar will provide an update of the expectations of regulatory authorities with respect to mutagenic impurities with focus on Nitrosamines.

The following topics will be addressed:
  • Overview ICH M7 principles
  • Nitrosamines – the Valsartan case
  • Limits, interim limits and acceptable intakes
  • Deadlines for submitting risk assessments
  • Variation procedures
A representative of a Regulatory Authority will explain the assessors approach in the assessment of dossiers in particular with respect to the Impurities section.

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