Download - INSEAD Risk Management Introduction
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IntroductionDr. David Cocker Senior Partner, MDCPartners
The ‘Big Pharma’ point of viewDr. Gerd Johnscher Senior Consultant, Pharmakon
Former Senior VP, Adviser to the CEO, UCB
The ‘Regulator’s point of viewProf. Bruno Flamion FUNDP – University of Namur and CHMP
The ‘Economist’s and Innovator’ point of viewProf. Koenraad Debackere Managing Director of K. U. Leuven R&D
Chairman of Gemma Frisius-Fonds
The ‘End-user’s’ point of viewMr. Jo De Cock General Manager, RIZIV/INAMI
Risk Management and Innovation in the Health Care Industry:Are they (in)compatible?
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Risk Management and Innovation in the healthcare industry
Good evening, my name is David Cocker and I am in the chair tonight.
are they (in)compatible ?
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Talking about risk is of course one of the riskiest things one can do. There are so many experts about !
( J.D.Remington, HSE, UK )
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What’s risk ?• The risk the first speaker will look up • wikipedia.org/historical_background/ “the definition of risk”.
its very simple
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Thx Peter Bernstein & Rembrandt
Once risks was in the hands of “others”
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Most of us view risk as either ……acceptable
…………..or unacceptable
That’s if we have a choice …………..
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Risk
Reputational
• People• Share price
Human Health• Efficacy• Safety
Financial•Investments
•Liabilities
Environmental• Ecotox
• Compliance
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Risk Management
Mitigate the risk of injury
Mitigate the risk of accidents
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Study suggests heart attack risk persisted for one year after patients stopped taking Vioxx.
Oct. 14 issue of The Lancet. The study "also
appears to show the higher risk started soon
after patients began taking Vioxx, though" the
analysis "notes a small sample size precludes
a definitive finding on this issue."
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Do you hold a good hand of cards ?
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The industry is good at communicating data.
NGO’s are good at communicating emotion
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Risk communication will be as important as the data to substantiate it
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RISK ASSESSMENT
RISK CHARACTERIZATION
DECISIONS & ACTIONS
RISK MANAGEMENT
Hazard identification Dose (conc)-response (effect) Exposure assessment
Regulatory
oversight
Management option: Consequences of the options at public health, economic, social & political levels
time
Chain of evidenceProof
You need a plan
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Towards an Evidence-based Toxicology
Expert-based vs. evidence-based
toxicology
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• Reformulate the product X 2
• Redesign the product X 5
• New ways to deliver function X 10
• Redesign the system X 20
Reducing EnvironmentalFootprint
Source : Miller, Chemistry Innovation (2007)
Design Strategies