Live Online: The Impurities Workshop Part II and III
Im Auftrag der ECA Academy

2/3 December 2020

Seminar Nr. 18617

All times mentioned are CET

Unser Seminarservice

Kosten

Für dieses Online Seminar ist leider keine Aufzeichnung verfügbar. Haben Sie jedoch Interesse, an einem kommenden Live Online Termin dieses Seminars teilzunehmen? Oder wünschen Sie eine individuelle Beratung zu unserem Schulungsangebot? Dann nutzen Sie einfach das folgende Kontaktformular, um uns Ihre Anfrage zu senden.

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Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Jürgen Martin, Martin-Consulting, Germany
Dr Lutz Müller, F. Hoffmann-La Roche, Switzerland
Dr Corina Nachtsheim, Quality Assessor, Germany
Dr Ulrich Rose, EDQM, France

Dr Andrew Teasdale, AstraZeneca, UK

Technical Requirements

For our Live Online Trainings and 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.

Programm

Part II: Nitrosamine Impurities on 02 December

European Pharmacopoeia Activities (Policy) on Mutagenic Impurities with Focus on Nitrosamines

Ph. Eur. General policy on DNA reactive impurities
Control of Nitrosamines in Ph. Eur.
Changes in individual and general monographs following the Sartan case
New general chapter on control of nitrosamines

Root Causes for Nitrosamine Impurities and Other Mutagenic Impurities – Practical Approaches to Assess the Risks

Development of a systematic risk based approach
Key factors and the development of a decision tree
- API
- Drug Product
- Packaging

ICH M7 Safety Risk Assessment and the Cohort of Concern – How to Deal with e.g. Nitrosamines

Principles of cancer risk estimation in ICH M7
Why was the cohort of concern excluded from ICH M7?
Applicability to use ICH M7 based cancer risk assessment to the cohort of concern
Nitrosamines, why are they in the cohort of concern?
Major risk factors for sources of nitrosamines in drugs
Way forward to handle cohort of concern within ICH M7

Workshop:
Conducting a Risk Assessment

In this Workshop the participants will work on several case studies and perform a risk assessment for different scenarios taking into account e.g. manufacturing equipment, dosage form of the drug product etc.

Nitrosamines and Other Genotoxic Impurities – Authorities' Expectations and Dossier Requirements

The assessor’s approach: principles of toxicological assessment
Structural alerts
Limits and Permitted Daily Exposure
The ALARP principle
Examples of low daily dose drug substances
Impurities derived from alkylating agents (mesilate, besilate, tosilate, diisothionate); examples
Nitrosamines – the Valsartan case
Potential mutagenicc residual solvents
Impurities derived from metal catalysts

Part III: Elemental Impurities on 03 December

European Pharmacopoeia Activities (Policy) on Elemental Impurities – an Update

Implementation of Q3D in Ph. Eur.
Changes in individual and general monographs
Harmonisation of general chapter 2.4.20
Second phase for revision of excipient monographs

Risk-Based Approach for Elemental Impurities in the Supply Chain

APIs, excipients, packaging materials impacting the purity profile
Evaluation of supply chain processes
Risk analysis as evaluation tool
Audits and monitoring programs as important sources
Testing strategies

Control Strategies for Elemental Impurities in Final Dosage Forms – Case Studies

Utilisation of Data as part of an Integrated EI Risk Assessment Process
Potential Sources of Elemental Impurities in the Finished Product
- API
- Equipment
- Container-closure system
- Excipients
Conclusions