Dr. Peer Schmidt
AbbVie
Referent:innen
All times mentioned are CEST
Zielsetzung
The first revision of the ICH Q9 guideline on risk management has provided further clarification on Quality Risk Management (QRM). Topics specifically addressed by the revision are subjectivity, formality and risk-based decision-making in QRM. In addition, the revision clarifies why the risk management process starts with hazard identification rather than risk identification, and how QRM can support medicinal product availability. The ICH Q9(R1) training package provides in-depth information on all these topics, and has an additional chapter on risk review. The aim of the event is to give you a compact overview of the 9 slide sets with over 300 slides of the ICH Q9(R1) training package.
Addressed are:
- Changes in Revision 1 of the ICH Q9 Guideline
- Hazard identification vs risk identification
- Formality according to ICH Q9(R1)
- Risk-based decision making
- Availability of medicinal products
- Risk review
- Reduction of subjectivity in risk management
As a member of the Expert Working Group (EWG), the speaker is a co-author of the ICH Q9(R1) Guideline.
Hintergrund
Since 2005, the ICH Q9 guideline has been the state of the art when it comes to quality risk management. It found its way into the EU GMP guidelines, initially as Annex 20 and was then incorporated into Part III, where it is still to be found today. In addition, an ICH Q9 briefing package was also developed and then made available on the ICH website. This briefing package was intended to clarify the Guideline.
At the end of 2020, the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) announced that it would revise the ICH Q9 guideline. After several years of work, the final revision was released as “R1” at the beginning of 2023. Changes were mainly made in four areas
- Subjectivity in risk assessment and QRM results
- Management of product availability risks
- Understanding how much formality is required for risk management
- Clarity on risk-based decision making
In addition, training material on risk review and hazard identification as the first step in QRM has been produced. Detailed training material on all these areas was published in October 2023; it consists of nine files totaling over 300 slides and some case studies.
Zielgruppe
The event is aimed at people who want to familiarise themselves with the topic of risk management in accordance with ICH Q9(R1) and in particular with the changes introduced by Revision 1.
Technical Requirements
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Programm
Gesamtes Programm als PDF herunterladen
The ICH Q9 Training Package Part I
Overview of the ICH Q9 revision
Overview of the ICH Q9 revision
- Hazard identification instead of risk identification
- Explanation of the change
- QRM tools for hazard identification
- Product development case study
- How hazards can be considered in the FMEA
- Human error
Formality according to ICH Q9(R1)
- Influencing factors
- Case study: Process development
- Case study: Change to the tablet press
Risks in drug availability
- Case study: Fictitious cancer drug
- Case study: Combination Product
The ICH Q9 Training Package Part II
Risk-based decision-making - a daily Task
- Examples of approaches to risk-based decision-making
- Case study: integrating different approaches to decision-making
Dealing with subjectivity
- Background and examples of subjectivity
- Tips for identifying and managing it
- Case study: Subjectivity in data integrity
The risk review
- Implementation
- Examples: Tablet cross-contamination, impurities, contamination control
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