Programme

EFGCP Workshop on
Quality Risk Management in Clinical Trials:
Demonstrating How to Implement
Risk-Based Monitoring
16 & 17 June 2014
University College London, United Kingdom
Organised by the
In partnership with
[email protected] – www.efgcp.eu
EFGCP Workshop on
Quality Risk Management in Clinical Trials: Demonstrating How to Implement Risk-Based Monitoring
16 & 17 June 2014 – UCL, London, United Kingdom (Final Programme)
Workshop Rationale
EFGCP in association with ACRES, EORTC and UCL are pleased to announce an interactive Workshop intended
to develop practical strategies and approaches for risk management and risk-based monitoring in clinical trials.
The workshop has been developed in close collaboration with thought-leaders from Health Authorities, industry,
CROs, academia and patients representatives. Up to now discussions on risk management have been mainly
theoretical and the practicalities of ‘how to’ has not been defined. Yet nobody is sure how much is actually ‘enough’
and how much is too little. Research Organisations are starting to create their approaches to risk assessment and
risk-based monitoring and yet there are still questions which need to be addressed, especially on how to define,
justify and "validate" of what is critical to patients' safety, integrity & rights, and data integrity. At the end of the
workshop a discussion round with regulators is planned to give participants guidance whether the approaches
developed during the workshop would be acceptable in their view.
Programme Committee
Christine de Balincourt
Ingrid Klingmann
Nicky Dodsworth
Valérie Journot
Raik Knieknecht
Peter Schiemann
Beat Widler
European Organisation for Research and Treatment of Cancer (EORTC), Belgium
Pharmaplex, European Forum of Good Clinical Practice (EFGCP), Belgium
Premier Research, European Forum of Good Clinical Practice (EFGCP), United
Kingdom
Université Bordeaux Segalen, INSERM, France
KCR – Knieknecht Clinical Research, Germany
Widler & Schiemann AG, Alliance for Clinical Research Excellence and Safety
(ACRES), Switzerland
Widler & Schiemann AG, Alliance for Clinical Research Excellence and Safety
(ACRES), Switzerland
Faculty
Moe Alsumidaie
Christine de Balincourt
Gunnar Danielsson
Nicky Dodsworth
Gail Francis
Ingrid Klingmann
Raik Knieknecht
Philip Lange Møller
Louise Mawer
Max Parmar
Randy Ramin-Wright
Volker Rönicke
Peter Schiemann
AnnexClinical, USA
European Organisation for Research and Treatment of Cancer (EORTC), Belgium
Medical Products Agency (MPA), Sweden
Premier Research, European Forum of Good Clinical Practice (EFGCP), United
Kingdom
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Pharmaplex, European Forum of Good Clinical Practice (EFGCP), Belgium
KCR – Knieknecht Clinical Research, Germany
Danish Health and Medicines Authority, Denmark
Mirabilitas, United Kingdom
MRC Clinical Trials Unit, University College London (UCL) & Institute of Clinical
Trials & Methodology, United Kingdom
International Institute for the Safety of Medicines (ii4sm), Switzerland
Strategy&, Germany
Widler & Schiemann AG, Alliance for Clinical Research Excellence and Safety
(ACRES), Switzerland
Workshop Venue
University College London
Lecture theatres 1 & 2, Cruciform Building
Gower Street, London WC1E 6BT
United Kingdom
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EFGCP Workshop on
Quality Risk Management in Clinical Trials: Demonstrating How to Implement Risk-Based Monitoring
16 & 17 June 2014 – UCL, London, United Kingdom (Final Programme)
Programme
Monday 16th June 2014
09:15
Registration and Welcome Coffee
09:50
Welcome
Max Parmar, Director of the MRC Clinical Trials Unit, University College London (UCL) & of the
Institute of Clinical Trials & Methodology, United Kingdom
09:55
Introduction
Ingrid Klingmann, Chairman of the European Forum of Good Clinical Practice (EFGCP) &
Pharmaplex, Belgium
MORNING SESSION - DEFINING THE RISKS
10:00
The Protocol for a Risk Adaptive Approach
This session sets the scene for the other workshops at this seminar. In this first session the core
team will analyze a real-life protocol and identify protocol elements that
• are critical for a Risk based Monitoring approach
• from a Quality by Design perspective are problematic or could be modified
Facilitators: Christine de Balincourt, Education Working Party, EFGCP & Quality Assurance &
Control Unit, European Organisation for Research & Treatment of Cancer (EORTC), Belgium &
Peter Schiemann, Widler & Schiemann AG, ACRES, Switzerland
11:20
Coffee Break
11:50
Design Space & Key Risk Indicators (KRIs)
Participants will learn about:
• What are KRIs (Key Risk Indicators) and what are they good for?
• How KRIs are shaped by the design space stipulated in the protocol
• How KRIs are designed - the principles and practical exercises
• How to work with KRIs for Quality Management purposes - case study exercises
• How to use KRIs to steer Risk Based Monitoring
• How are threshold for KRIs validated
Facilitators: Peter Schiemann, Widler & Schiemann AG, ACRES, Switzerland & Randy RaminWright, International Institute for the Safety of Medicines (ii4sm), Switzerland
12:45
Lunch
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EFGCP Workshop on
Quality Risk Management in Clinical Trials: Demonstrating How to Implement Risk-Based Monitoring
16 & 17 June 2014 – UCL, London, United Kingdom (Final Programme)
AFTERNOON SESSION - RISK-BASED MONITORING
14:00
Data Management & Statistical Monitoring
Participants will learn about:
• The use of EHR databases to validate the protocol design
• The use of statistical performance assessments to identify proactively “performing” sites
and differentiate these from “problem sites”
• The use of EHR and FDA medical data to establish analytical parameters for KRI
thresholds
• Use of statistical analysis to generate analytical triggers for audits
This section addresses the QbD aspect of RbM. Without a solidly tested study design statistical or
centralized monitoring is to fail.
In the second part the validation of KRIs and other decision making algorithms will be explored by
means of examples “from the real world”
• How can we use EHR data to set a reasonable baseline for a KRI threshold
• What is a simulation exercise and how does it work. Monte Carlo simulations as a baseline
for KRI thresholds?
• What else needs to be done to bestow credibility to our “assumptions”?
Facilitators: Moe Alsumidaie, AnnexClinical, USA (via WebLink) & Peter Schiemann, Widler &
Schiemann AG, ACRES, Switzerland
15:15
Coffee Break
15:45
Site Monitoring Plans
This workshop will start with a short overview of FDA’s recommendation (Oversight of Clinical
Investigations – A Risk Based Approach to Monitoring, Aug 2013) looking at the design of
Monitoring Plans, concentrating on the identification of critical and non-critical data on the given
example of a real protocol by answering the following questions:
• Which data points can be verified centrally?
• Which data points require an on-site verification?
• What are the critical data points where data errors are not acceptable?
• How decision algorithm is defined when data are outside the design space?
Facilitator: Raik Knieknecht, Education Working Party, EFGCP & KCR – Knieknecht Clinical
Research, Germany & Ingrid Klingmann, EFGCP & Pharmaplex, Belgium
17:00
Summary of the key lessons learnt
Ingrid Klingmann, EFGCP & Pharmaplex, Belgium
17:10
Close
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EFGCP Workshop on
Quality Risk Management in Clinical Trials: Demonstrating How to Implement Risk-Based Monitoring
16 & 17 June 2014 – UCL, London, United Kingdom (Final Programme)
Tuesday 17th June 2014
08:50
Welcome Coffee
09:20
Welcome & Introduction
Ingrid Klingmann, EFGCP & Pharmaplex, Belgium
MORNING SESSION: QUALITY & COMMUNICATION PLANS
09:30
Audit, Quality Plans and Risk Management
What is risk, how can we measure and minimise it? You will hear how to put plans together to
cover your areas of responsibility (no matter how large or small). The dangers of risk tools
rebounding and causing you additional headaches will be discussed. Get it right, and risk
assessment will mean your resource is placed in appropriate areas and helps to safeguard your
research. Get it wrong, and risk assessments may give you a false sense of security, right up to
the point you receive a major finding.
Facilitators: Louise Mawer, Mirabilitas, United Kingdom & Nicky Dodsworth, Education Working
Party, EFGCP & Global QA, Premier Research, United Kingdom
11:00
Coffee Break
11:30
Risk Communication & Change Management
The session will deal with two topics: Achieving the required behavioral change for sustainability of
prospective risk management and risk communications.
Participants will better understand how to facilitate the change in mindset of stakeholders that is
required during the transition from the traditional quality management to the prospective quality
risk management approach and how to make it stick. In addition, participants will better
understand the key success factors for meaningful risk reporting to various audiences.
Facilitators: Volker Rönicke, Strategy&, Germany & Peter Schiemann, Widler & Schiemann AG,
ACRES, Switzerland
12:45
Lunch
AFTERNOON SESSION - RISKS AND THE REGULATORS
13:45
Working with the Regulators
In this session, the invited regulators, who will observe the two days of the workshop and its
results, will discuss the outcome of the individual sessions and how they fit the requirements put
forward in recent publications by the agencies (EMA, FDA, MHRA and others).
Chairpersons: Nicky Dodsworth, Education Working Party, EFGCP & Premier Research, United Kingdom &
Peter Schiemann, Widler & Schiemann AG, ACRES, Switzerland
Panelists:
Gunnar Danielsson, Medical Products Agency (MPA), Sweden
Gail Francis, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Philip Lange Møller, Danish Health and Medicines Authority, Denmark
15:15
Summary of the key lessons learnt
Ingrid Klingmann, EFGCP & Pharmaplex, Belgium
15:20
Close of Workshop
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