Breakfast II: Knowledge Management - Q12 Update … · Ursula Busse PhD MBA ... • Denyse Baker,...
Transcript of Breakfast II: Knowledge Management - Q12 Update … · Ursula Busse PhD MBA ... • Denyse Baker,...
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2017 PDA Annual Meeting | April 3-5, 2017 | Anaheim Marriott | Anaheim, California
Breakfast II: Knowledge Management – Q12 Update
The Future State ‐ Knowledge Management and Sharing to Reduce Regulatory Burden Ursula Busse PhD MBA
Head Quality Intelligence, External Relations
Novartis
2017 PDA Annual Meeting | April 3-5, 2017 | Anaheim Marriott | Anaheim, California
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Breakfast II: Knowledge Management – Q12 Update
Breakfast II: Knowledge Management - Q12 Update By: Ursula Busse, PhD
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2017 PDA Annual Meeting | April 3-5, 2017 | Anaheim Marriott | Anaheim, California
Knowledge is important
ICH Q8 (November
2005)
30
ICH Q9 (November
2005)
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ICH Q10 (June 2008)
20
ICH Q11 (May 2012)
35
ICH Q12 (in progress)
?
Breakfast II: Knowledge Management – Q12 Update
Number of times the term «knowledge» is mentioned in ICH guidelines
The basic economic resource –the means of production –
is no longer capital, nor natural resources, nor labor.
It is and will be knowledge.”
– Peter Drucker
2017 PDA Annual Meeting | April 3-5, 2017 | Anaheim Marriott | Anaheim, California
Knowledge
• Knowledge develops from data, information
• Knowledge is information in action
– Knowledge needs to flow
• Knowledge is sticky
– 20% of knowledge is explicit
– but often not accessible
– 80% of knowledge is tacit
Breakfast II: Knowledge Management – Q12 Update
“Connectivity above hierarchies”
Breakfast II: Knowledge Management - Q12 Update By: Ursula Busse, PhD
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2017 PDA Annual Meeting | April 3-5, 2017 | Anaheim Marriott | Anaheim, California
How Knowledge creates Value
• Dynamic knowledge flow between tacit and explicit knowledge
• Integrated use of knowledge gained during the product lifecycle
Breakfast II: Knowledge Management – Q12 Update
SECI model (Nonaka, 1994)
2017 PDA Annual Meeting | April 3-5, 2017 | Anaheim Marriott | Anaheim, California
Knowledge Management
ICH Q10“A systematic approach to acquiring, analyzing, storing, and disseminating information related to products, manufacturing processes and components”
Breakfast II: Knowledge Management – Q12 Update
Systematic
1. Acquire2. Analyze
3. Store4. Disseminate
Breakfast II: Knowledge Management - Q12 Update By: Ursula Busse, PhD
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2017 PDA Annual Meeting | April 3-5, 2017 | Anaheim Marriott | Anaheim, California
Knowledge over the product lifecycle
• Knowledge grows over the product lifecycle
• Knowledge is used to support change management
• Challenges– Many different
changes– Supply chain
complexity– Long timelines
Breakfast II: Knowledge Management – Q12 Update
Pharmaceutical Development
Technology Transfer
Commercial ManufacturingProduct
Discontinuation
2017 PDA Annual Meeting | April 3-5, 2017 | Anaheim Marriott | Anaheim, California
Effective Knowledge Management over the Product Lifecycle
Breakfast II: Knowledge Management – Q12 Update
Rapid and comprehensive access to product, process and technology knowledge
Timely and
accurate decision making
Effective QRM
Tacit knowledge is consistently
harnessed and shared
Company‐external knowledge is
incorporated into internal processes
Explicit knowledge is
readily available to those who
need it
Effective Knowledge Management ACROSS THE ENTIRE SUPPLY CHAIN
Reliable product quality
State of control
Sustainable product realization
Continual improvement
Breakfast II: Knowledge Management - Q12 Update By: Ursula Busse, PhD
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2017 PDA Annual Meeting | April 3-5, 2017 | Anaheim Marriott | Anaheim, California
Effective QRM supports PAC
• Risk reduction – Identify changes that reduce risk of quality
failures /manufacturing problems; improve process capability
• Change categorization– Distinguish changes of regulatory relevance
from changes that can be managed solely in the PQS
• Effective change control– Assess risk level before and after PAC
implementation to ensure no increase in risks to product quality or patient safety
Breakfast II: Knowledge Management – Q12 Update
2017 PDA Annual Meeting | April 3-5, 2017 | Anaheim Marriott | Anaheim, California
Opportunities for regulatory flexibility
ICH Q10, Annex 1
Manage PAC with reduced regulatory oversight
Effective PQS
Effective QRM
Effective KM
Effectiveness Checks (Industry)
Breakfast II: Knowledge Management – Q12 Update
• PAC verification– Monitor deviations, process trends, analytical trends – Trend stability, deviations, OOS, technical / medical
complaints, inspection/audit outcomes
• PQS effectiveness KPIs• Internal audits• Management review
Effectiveness Checks (Regulator)• Inspections
– Verify that processes are in place and followed
Breakfast II: Knowledge Management - Q12 Update By: Ursula Busse, PhD
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2017 PDA Annual Meeting | April 3-5, 2017 | Anaheim Marriott | Anaheim, California
Established reporting channels result in fragmented access to company knowledge
• Knowledge shared with regulators is mostly explicit
• Assessors see part of it, inspectors other parts
Breakfast II: Knowledge Management – Q12 Update
Assessors
Inspectors
e.g.Submissions
APR/PQRSite Master
FileQuality ManualSOPs
2017 PDA Annual Meeting | April 3-5, 2017 | Anaheim Marriott | Anaheim, California
Enhanced knowledge sharing between industry and regulators
Convert tacit knowledge into explicit knowledge, make it available
•Post‐Approval Change Management Protocols (PACMPs)
•Documented Lifecycle Management Strategy
Leverage opportunities for tacit knowledge exchange
• Meetings between MAH and Assessors
• During Inspections
Documented Lifecycle Management Strategy• Facilitates communication between Company and Regulator; provides opportunity to discuss risks and plan proactively
• Elements of a product’s LCM strategy
Product Established Conditions and Control Strategy Summary
Planned changes and regulatory approaches
Summary of product lifecycle management in the PQS
• Managing Product Knowledge During the Commercial Lifecycle
• Control System Management
• Managing Post‐Approval Changes
Breakfast II: Knowledge Management – Q12 Update
Breakfast II: Knowledge Management - Q12 Update By: Ursula Busse, PhD
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2017 PDA Annual Meeting | April 3-5, 2017 | Anaheim Marriott | Anaheim, California
Knowledge sharing promotes better decision makingIndustry ‐ RegulatorsEnhanced communication above established reporting channels
Inspector ‐ AssessorCommunication between inspectors and assessors
Breakfast II: Knowledge Management – Q12 Update
Between RegulatorsCommunication between regulators
PAC evaluation in its context Mutual reliance / recognitionPAC evaluation based on increased knowledge
Enhanced regulatory decision making
Access to tacit
knowledge
2017 PDA Annual Meeting | April 3-5, 2017 | Anaheim Marriott | Anaheim, California
Knowledge sharing reduces regulatory burden
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Breakfast II: Knowledge Management - Q12 Update By: Ursula Busse, PhD
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2017 PDA Annual Meeting | April 3-5, 2017 | Anaheim Marriott | Anaheim, California
Regulatory flexibility means less control..
• Trust is a key success factor for regulatory flexibility
• Trust needs to be earned
• Knowledge sharing (transparency) with regulators increases trust
Breakfast II: Knowledge Management – Q12 Update
2017 PDA Annual Meeting | April 3-5, 2017 | Anaheim Marriott | Anaheim, California
Key take home messages
• Knowledge is needed to make the right decision
• Knowledge sharing enhances trust
• Trust promotes regulatory flexibility
Breakfast II: Knowledge Management – Q12 Update
Quality of knowledge depends on integrity of source data
Increased knowledge promotes better decision making
Breakfast II: Knowledge Management - Q12 Update By: Ursula Busse, PhD
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2017 PDA Annual Meeting | April 3-5, 2017 | Anaheim Marriott | Anaheim, California
Acknowledgement
PDA PAC iAM Core Team
• Anders Vinther, Sanofi Pasteur
• Emma Ramnarine, Roche/Genentech
• Marcello Colao, GSK Vaccines
• Julia Edwards, Biogen
• Kara Follman, Pfizer
• Karolyn Gale, Emergent BioSolutions
• Kassidy Good, Mylan Laboratories
• Barbara Jengtes, PhACT GmBH
• Maik Jornitz, G‐CON LLC
• Morten Munk, NNE Pharmplan
• Kevin O’Donnell, HPRA
• Melissa Seymour, Biogen
• Mihaela Simianu, Pharmatech Associates
• Lisa Skeens, Pfizer
• Denyse Baker, PDA
• Rich Levy, PDA
Breakfast II: Knowledge Management – Q12 Update
Breakfast II: Knowledge Management - Q12 Update By: Ursula Busse, PhD