Quality Risk Management Summit

Quality Risk Management Summit

Lisbon, Portugal

Course No 16327


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Speakers from Regulatory Agencies:
Colm Reddington, MHRA, U.K.
Dr Karmin Saadat, AGES, Austria and PIC/S QRM Expert Circle
Dr Franz Schönfeld, GMP Inspector, Germany

Speakers from Industry:
Sofia van Berlekom, AstraZeneca, Sweden
Tor Gråberg, AstraZeneca, Sweden
Dr Brigitte Gübitz, VTU Engineering, Austria
Aidan Madden, FivePharma, Ireland
Dr Lisa Matzen, Boehringer Ingelheim, Germany
Prof Jose C. Menezes, 4Tune Engineering, Portugal
Rui Pinto, Hovione, Portugal
Emma Ramnarine, Genentech/Roche, USA
Audrey Schwebel, Merck, France
Dr Remo Studer, Galexis, Switzerland


  • Discuss how to implement integrated quality risk management principles over the life cycle of your products.
  • Learn how to implement optimised Quality Risk Management (QRM) approaches to increase efficiency and to meet the expectations of the regulators.
  • Take advantage to meet, listen to and interact with colleagues, regulators and industry experts.


The ultimate responsibility for the performance of a medicinal product over its lifetime, its safety, quality and efficacy, lies with the marketing authorization holder (MAH). To achieve the quality objective, “there must be a comprehensively designed and correctly implemented system of Quality Assurance incorporating Good Manufacturing Practice, Quality Control and Quality Risk Management.” [EU-GMP Guidelines, Part 1, Chapter 1].

Quality Risk Management (QRM) was formally introduced to the pharmaceutical industry in 2005 with the publication of ICH Q9 Guideline. But QRM is not only limited to the manufacturing process. It starts much earlier in the development phase and lasts until the distribution. Even more, the new ICH Q12 Draft Guideline (Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management) likes to facilitate risk-based regulatory oversight, e.g. for Post-Approval Change Management (PACM).

No matter in which area, the intent of QRM is to make data-driven and scientifically sound decisions and to support the agreed actions. Companies are currently establishing integrated risk-based thinking into their quality and regulatory affairs systems over the lifecycle of their products. This is more than just a task of the Quality Unit; it is bringing together knowledgeable people from different disciplines with various informed perspectives. The background and examples will be discussed in this QRM Summit.

Target Group

This conference is designed for all persons in pharmaceutical, biopharmaceutical and API industry who establish, manage and improve quality risk management systems.


Part 1: QRM in the Lifecycle Management

Changing the Habits: Value and Role of Quality Risk Management
  • Regulatory requirements on risk management over the whole product lifecycle
  • The Importance of QRM
  • How ICH Q8-Q12 Guidelines work together from
  • Development to Product Realisation and Continuous Improvements
Life-Cycle Risk-Management in Quality by Design (QbD)
  • Status Quo of risk management in the pharmaceuticals industry
  • How to implement a lifecycle risk management
  • Model of Object Oriented Risk Management
  • Risk communication – a key enabler for efficient risk management
  • Advantages by working with innovative risk management tools

Part 2: QRM in ICH Q12

Post approval CMC Lifecycle Management – Mitigation of global complexity?
  • Agile Post-Approval Change Management within ICH Q12
  • PACM Protocols & Classification of Changes
  • Regulatory Flexibility & Robustness of Current
  • Pharmaceutical Quality Systems
Risk-based Post-Approval Development and Change Management
  • How to use QRM to assess criticality (minor/ major) of specific post-approval changes
  • PACM protocols (access to data & info making established-conditions)
Views and Expectations of the Regulators
  • ICH Q12: a way to relief burden for regulators and industry to the benefit of patients by harmonising change classifications, requirements and review timelines?
  • Risk-based regulatory oversight and optimisation of resources for assessment and inspection
  • What type of changes will benefit
  • Concerns and implications

Part 3: QRM meets Industry 4.0

Knowledge Management – a central Element of Industry 4.0 in Pharma Manufacture
  • The knowledge cycle at a Pharmaceutical CMDO
  • Knowledge Management and Industry 4.0 – How to make the best use of digitalized data?
  • Case studies
  • Challenges and next steps
QRM for agile Post-Approval Change Management
  • Agility in PACM is a requirement of Industry 4.0
  • QRM used over lifecycle enables risk-based decisions and knowledge-excellence
  • Risk-management best practices for PACM
  • Case Studies

Part 4: QRM in GMP/GDP

Is QRM (really) a new GMP Requirement?
  • The Inspector’s View: Expectations
  • Examples
How to effectively use QRM in the GMP Environment
  • QRM –more than risk assessment
  • Defining what the risk is - vital for correct and effective QRM
  • How to integrate QRM in the other PQS elements
  • Effort and formality – adapt QRM to your everyday business as well as major project
QRM in a complex global pharmaceutical Organisation as enabler for Knowledge Management and Quality Oversight
  • How to implement QRM oversight: harmonization as one of the key elements
  • Management of risks; Risk register principles including escalation of risks in a global organization
  • Example of implementation of an IT tool enabling a better overview, follow-up of overall risks and knowledge management
  • Delimitation of responsibilities and interfaces over the product life cycle based on a common denominator
QRM and the new Annex 1
The term “risk management” can be found 4 times and “risk assessment” 25 times in the new Annex 1. Discuss how to establish an integrated risk assessment process within sterile manufacturing processes.

GDP: Practical Approaches to QRM using FMEA
  • Examples from: Inventory, High-level risk assessment (HLRA), FMEA
  • Protocols and documentation

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