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

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

Seminar Nr. 18617

All times mentioned are CET

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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
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.

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