- email:registrations@informa-ls.com
- phone:+44(0)20 7017 7481
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Quality Risk Management for GCP in Clinical Development
9 - 10 November 2011
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Quality Risk Management for GCP in Clinical Development
Identifying the key risk indicators (KRIs) to ensure quality, meet new requirements and guarantee patient safety
Quality Risk Management for Good Clinical Practice in Clinical Development. Identification of quality-associated hazards pertaining to clinical development
- Estimation and evaluation of the associated risks
- Means by which these risk can be controlled
- Methods to monitor the effectiveness of the quality controls in place
- Ensuring readiness for audit and inspection under GCP
This is an opportunity for those implenting quality risk management methodologies to share experiences and learn from peers to ensure Good Clinical Practice (GCP) compliance; with the ultimate goal of accelerating time to market.
November 2011 Conference Highlights
- Explore the implementation of QRM approaches at J&J and learn about the impact of the FDA-483
- Attend a free legal breakfast briefing to better understand the UK Bribery Act and other international anti-corruption legislation
- Learn about the implementation of QRM approaches including the quality metrics put in place at Bayer HealthCare Pharma and Boehringer-Ingelheim
- Discover how to ensure GCP compliance when conducting global trials with key talks from WHO, Novartis and AstraZeneca
- Understand tools to mitigate risk in study oversight from Eisai and Milennium
- Assess the use of quality metrics to ensure quality control within a QRM model with F. Hoffmann-La Roche
- Understand GCP audit and inspection finding and exploring the best practice for implementing an effective audit strategy with lessons from Merck Serono and Amgen
Who You Will Meet...
Who You Will Meet...
Brenda Scarth
Director, Compliance Advice & Assurance
AstraZeneca, UK
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Rolf Banholzer
Head Corporate eCompliance, HEad Dev QA eCompliance
Novartis, Switzerland
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Johann Pröve
Head Global Data Management
Bayer Vital GmbH, Germany
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Arthur Hecht
Head Quality Management Medicine & Regulatory WE South
Boehringer-Ingelheim, Germany
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Donna Edgerton
Senior Director, Clinical Quality Standards QA
Millennium, USA
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Brian O'Neill
Global Head, External Alliances/Enterprise Systems QRM
F. Hoffmann-La Roche, Switzerland
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Amer Alghabban, Director GCP QA Auditing, Merck Serono, Switzerland
Brian O’Neill, Global Head, External Alliances/Enterprise Systems QRM, Roche, Switzerland
Brenda Scarth, Regional Director, Compliance Advice & Assurance, AstraZeneca, UK
Geoff Taylor, Director, QA, Eisai, UK
Greg Koski, Associate Professor of Anaesthesia, Massachusetts General Hospital, Harvard Medical School, USA
Kevin Painter, Head, Quality Risk Management, Global Development, Bayer HealthCare Pharmaceuticals, Germany
Petra Knupfer, Research Ethics Committee, Landesärztekammer Baden-Württemberg, Germany
Lars Brolund, Director, Processes & Compliance, AstraZeneca, Sweden
Michael Mihut, Quality Management, World Health Organisation, Switzerland
Steve Berry, Vice President, Global System Quality Assurance, Johnson & Johnson, UK
Valeri Mikhailovski, Head, Global Clinical Quality & Compliance, Novartis Vaccines, USA
Pre-conference workshop W: Tuesday 8th November
Implementing risk-based decision making within clinical trials
- Building quality at key points in the clinical trial process
- What to consider when setting up QRM at your company including identifying key risk indicators (KRI)
- Expanding the scope of QRM
- Leveraging pre-existing information into useful decisions
- Implementing a “quality by design” approach to overcome shortcomings in quality and compliance
- Appling lessons from manufacturing, ICH Q9 and Q10: E6B GCP regulations
Led by: Ken Schiff, Quality Risk Management Consultant, Quality Risk Management Associates & ii4sm, USA
Evening Seminar Y: Wednesday 9th November 2011
Share and share alike: Barriers and benefits to data sharing in drug development
Led by: Greg Koski, Associate Professor of Anaesthesia, Massachusetts General Hospital, Harvard Medical School, USA
- Assess the current extent to which information is shared among pharmaceutical companies, the public and third-parties during the process of drug development
- Understand why some information is shared while other information is not
- Explore potential benefits and barriers to more extensive data sharing
- Develop alternative models for data-warehousing, mining and sharing that would benefit the drug development process
- Consider incentives and disincentives for such models and appropriate oversight and regulatory mechanisms
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Dates and Venues
09 Nov 2011 - 10 Nov 2011
Courtyard by Marriott Hotel Basel
