TransCelerate BioPharma is a non-profit organization whose mission is to collaborate across the biopharmaceutical industry to identify and implement solutions to improve the delivery of new medicines. The Quality Management System initiative aims to advance quality management across the industry by developing a conceptual framework for clinical quality management systems. The initiative has published several papers outlining its frameworks and tools. Its upcoming milestones include releasing additional tools and publishing additional framework papers on risk management and processes.

1. Updated: 08 March 2017
Overview
Quality Management
System

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Our Innovative Leaders
TransCelerate BioPharma is proud to
have leadership from major
biopharmaceutical companies –
who have dedicated their careers
to medicine, science and ensuring
access to life-saving medicines
through efficient and safe research
and development.
We are fortunate to have the
greatest minds in pharmaceutical
R&D dedicated towards this
common goal of identifying
common issues and model solutions
that will drive efficiencies into the
R&D process.
About TransCelerate
TransCelerate BioPharma Inc.
was launched in 2012 as a
non-profit organization with a
mission to collaborate across
the biopharmaceutical
research and development
community to identify,
prioritize, design and facilitate
the implementation of
solutions to drive efficient,
effective and high-quality
delivery of new medicines,
improving the health of
people around the world.
Our Mission Statement
TransCelerate BioPharma’s mission is
to collaborate across the global
biopharmaceutical research and
development community to identify,
prioritize, design and facilitate
implementation of solutions designed
to drive the efficient, effective and
high quality delivery of new
medicines.
Our Members
TransCelerate BioPharma is
comprised of the world’s leading
biopharmaceutical companies, with
the vision of accelerating and
enhancing the research and
development of innovative new
therapies. The spirit of innovation and
collaboration occurs across
TransCelerate Member
Companies on Initiative goals.
Welcome to
TransCelerate BioPharma Inc.

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TABLE OF CONTENTS
Initiative Overview
Value Proposition
Stakeholder Benefit / Impact
Accomplishments to Date
Upcoming Milestones
Who’s Involved
Additional Resources

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Quality Management System (QMS)
Unmet Need:
Currently industry guidance for quality in clinical development is fractured across
multiple documents from multiple sources. The regulators require improved quality, the
inspectors are expecting QMSs to be operating effectively. There is no industry-wide
conceptual framework for clinical Quality Management that aims to address quality
and monitor and improve performance in complex clinical development-specific
environments. Such systems exist in other industries, such as pharmaceutical
manufacturing.
Objective:
Advance ways to improve quality industry-wide
through partnership interfaces with Regulatory
Authorities and other industry stakeholders.
Benefits:
Speed medicines to market through high quality
research and development to serve patients
through focused quality management system,
increase efficiency and patient safety, and
reduce burden on sites.

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Vision
Transform the
application of quality
science to improve
patient safety, data
reliability, and data
integrity
Approach
Advance transformational focus areas of tangible and
intangible value that will move the Clinical Quality
needle by:
• Defined and published conceptual frameworks for:
– Clinical QMS Vision & Outline
– Clinical QMS Concept Paper
– Clinical Knowledge Management
– Issue Management
• Delivered additional operational tools and resources
for the manuscripts listed above
• Deliver a self assessment tool for a clinical QMS for
industry use (Assessing the CQMS)
• Explore, develop and deliver the principles and model
approach for an enterprise level Risk Management
conceptual framework
• Explore, develop and deliver a best practice
framework for Processes, Documentation and
Training/Performance
Quality Management System (QMS)

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• Clinical QMS requirements are
fragmented across multiple guidances,
with no unifying guidance from industry
body like ICH
• Individual companies’ QMS are
challenged to reduce reoccurring
quality issues common in the industry
• Companies cannot solve for, and
continue to see repetitive quality issues
which are not captured by monitoring,
audits, or inspections
• Member Company and HA feedback
suggests more practical examples and
tools are needed
• Poor industry image/reputation
• Patient and consumer benefit through
increased safety and more drugs to
market quicker
• Achieve unifying ICH guidance (or
similar)
• Collaborate to solve repetitive quality
issues which individual companies have
been unable to solve on own
• Provide improvement to industry
image/reputation through commitment
to improve patient safety, data integrity,
and reliability
• Moves the quality issue needle from a
reactive to proactive state
• Focus on “Issues That Matter”
Value Proposition / Benefits When Delivered
Through development of Quality Management Systems…
Unmet Need Value Proposition

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• Improved image and credibility of medical
research through commitment to improve
patient safety, data integrity, and reliability.
• Collaboration solves repetitive quality issues
which individual companies have been
unable to solve.
• Cost avoidance and increased efficiency
through reduction of remediation and re-
work costs associated with addressing quality
issues.
• ICH guidance would achieve consistent
framework for managing quality across the
industry and benefit the industry on a wider
scale
• Increased safety during clinical trials.
• Less study delays due to remediation
• The process to get drugs to market is made
quicker through improved processes.
Stakeholder Benefit/Impact
PatientsMember Company
• Increase in industry ability to proactively
adapt to Regulatory changes.
• Provides consistent quality framework for
Regulatory Authorities to evaluate and
measure “Issues That Matter.”
• Decreased burden on the sites by
streamlining clinical trial processes and
focusing on measuring “Issues That Matter.”
SitesRegulatory Authorities

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2015 2016 2017
Accomplishments to Date
Since endorsement as a workstream in June 2014
by TransCelerate Board of Directors the QMS workstream has:
• Published a Concept Paper
Vision and Outline for a
Clinical QMS Conceptual
Framework (DIA Therapeutic
Innovation & Regulatory
Science(TIRS) Sept 2015).
• Began broadly socializing the
QMS concepts with Regulatory
agencies (FDA, EMA, PMDA,
Health Canada, BfARM,
COFEPRIS, CFDA, MFDS,
ANVISA) and industry
stakeholders (eg, PhRMA,
JPMA, EfPIA, SCRS) to gain
support for the conceptual
framework as an ICH
Guidance.
• Published conceptual
frameworks in DIA
Therapeutic Innovation &
Regulatory Science(TIRS) for:
• Clinical QMS Concept Paper
(July 2016)
• Issue Management (July
2016)
• Clinical Knowledge
Management (August 2016)
• Conducted
interviews/surveys to collect
data from Member
Companies on overall QMS
concepts, Issue
Management and Clinical
Knowledge Management.
• Established an Asia Pacific
team accountable for review
of deliverables and
messaging in that region
• Updated website with more
interactive features, tools
and resources for industry
use
• Plan surveys for Risk
Management and
Processes/Documentation/
Training
• Plan to initiate new External
Engagement Strategy and
Governance
• Plan to deliver tool for
industry use in 2Q2017 on
Assessing the CQMS.
• Plan to publications on Risk
Management &
Processes/Documentation/
Training 4Q2017

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Upcoming Milestones 2017
• Release all previously developed tools and resources to external web site for industry
use (end of Q1)
• Publish the Assessing the cQMS Tool for industry use (end of 2Q)
• Change Management Tools released to external web site for industry use (end of 2Q)
• Develop Realization and Transition Plan (2-4Q)
• Submit the Risk Management conceptual framework to DIA TIRS (Dec 2017)
• Submit the Processes conceptual framework to DIA TIRS (Dec 2017)
End of 4Q
Risk Management
Paper submitted to
DIA TIRS
Processes Paper
submitted to
DIA TIRS
End of 3Q
Realization
& Transition
Plans
submitted
for Approval
Jul Aug Sep Oct Nov DecJan Feb Mar Apr
End of Q2
Publish
Assessing the
cQMS Tool
Release
Change
Management
tools
Begin to draft
Realization&
Transition
Plans
May Jun
End of Q1
Release all
tools for
industry use

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Who’s Involved
Workstream Lead
Executive Leadership
Core Team
Andy Lee (Merck) – Co-Sponsor
Deb Driscoll (Merck) – Co-Sponsor
Magda Borda (Roche)
* NOTE: Participating on the Working Groups does not require implementation of the workstream’s solutions

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View the entire Quality
Management System
team.
Team Roster Initiative Assets Knowledge Vault
View the Quality
Management System
Assets.
View the Vision and
Outline publication for
the Clinical QMS
Conceptual Framework
Learn more about
Quality Management
System.
Additional Resources

12. THANK YOU