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Cross-functional Standards Governance for Pharma - PhUSE 2017 2
Standards Governance for Pharma Warwick Benger PhUSE 2017 The - - PowerPoint PPT Presentation
Standards Governance for Pharma Warwick Benger PhUSE 2017 The - - PowerPoint PPT Presentation
Cross-functional Standards Governance for Pharma Warwick Benger PhUSE 2017 The opinions expressed in this presentation do not necessarily represent those of GSK and are non -binding recommendations. Cross-functional Standards Governance
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– The challenge – Examples – A modernised approach
Cross-functional Standards Governance for Pharma
Agenda
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Standards Governance for global industry standards The challenge
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Cross-functional Standards Governance for Pharma
The challenge
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Cross-functional Standards Governance for Pharma
The challenge
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Cross-functional Standards Governance for Pharma
The challenge
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Cross-functional Standards Governance for Pharma
The challenge
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Cross-functional Standards Governance for Pharma
The challenge
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Cross-functional Standards Governance for Pharma
The challenge
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Cross-functional Standards Governance for Pharma
The challenge
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Cross-functional implementation challenges for global standards Examples
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Data management Clinical Operations Regulatory Operations Clinical Dictionaries Stats & Programming Pharmaco- kinetics Trial Summary for legacy studies
Cross-functional Standards Governance for Pharma
Examples
Systems / IT
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Data management Clinical Operations Regulatory Operations Clinical Dictionaries Stats & Programming Pharmaco- kinetics PK Terminology
Cross-functional Standards Governance for Pharma
Examples
Systems / IT
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Data management Clinical Operations Regulatory Operations Clinical Dictionaries Stats & Programming Pharmaco- kinetics WHO-DD adoption (PMDA and FDA)
Cross-functional Standards Governance for Pharma
Examples
Systems / IT
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Data management Clinical Operations Regulatory Operations Clinical Dictionaries Stats & Programming Pharmaco- kinetics RACE coding
Cross-functional Standards Governance for Pharma
Examples
Systems / IT
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An updated approach to cross-functional standards governance
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Cross-functional Standards Governance for Pharma
A modernised approach
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Cross-functional Standards Governance for Pharma
Clinical Data Standards – Board & Advisory Committee
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Cross-functional Standards Governance for Pharma
Clinical Data Standards - Advisory Committee
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Cross-functional Standards Governance for Pharma
Every company should have a standards catalogue
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Cross-functional Standards Governance for Pharma
Business users as 1st line support and content developers
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Cross-functional Standards Governance for Pharma
– The adoption of global industry standards has increased the complexity and impact of change management related to the implementation of new standards, versions and
- content. In particular, the likelihood of impacts on process and technology, and wider
cross-functional organization is increased. – A more evolved structure for standards curation and governance is recommended, through significantly increased engagement with cross-functional business users which enhances the flow of information between external sources, internal standards teams and end users, and helps drive standards content development. – The use of a standards catalogue within a company is highly recommended as a mechanism to ensure clear line of sight for all staff. – Two levels of governance are recommended;
– a Board which is responsible for approval of general operating principles and new work efforts, and enabling of resource, as well as advocacy and risk management. – an Advisory Committee which is responsible for tracking and managing the company standards, identifying the need for remediation, and defining and planning updates to the standards as appropriate.
In summary
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