Left & Right Brain Thinking Read out the color not the word - - PowerPoint PPT Presentation

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Left & Right Brain Thinking Read out the color not the word - - PowerPoint PPT Presentation

Left & Right Brain Thinking Read out the color not the word Yellow Blue Orange Green Black Red Red Purple Yellow Black Orange Green Purple Blue Red 24 Hour Challenge PhUSE 09 Accelerating Clinical Welcome Development


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SLIDE 1

Left & Right Brain Thinking

Read out the color not the word

Yellow Blue Orange Black Red Green Purple Yellow Red Orange Green Black Blue Red Purple

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SLIDE 2

Welcome

24 Hour Challenge PhUSE 09

Accelerating Clinical Development

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SLIDE 3
  • Michael Whitworth
  • Business Analyst – AstraZeneca Pharmaceuticals
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SLIDE 4

24 Hour Challenge Overview

  • Optimising the way AstraZeneca responds to

regulatory requests

  • Regulatory Knowledge and Information
  • Submission to Regulatory Authorities
  • Defence of product information
  • ’24’ Hours is an aspirational target
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SLIDE 5

24 Hour Challenge Overview

  • Outlining the problems – root cause analysis
  • Knowing how information flows
  • Within and across functions
  • Gain a true understanding of the information that

supports the label –

  • Data
  • Information
  • Knowledge
  • Wisdom
  • Measure and improve the speed and accuracy of

how it can be accessed

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SLIDE 6

Create, Store, Retrieve

  • Building awareness

“How we create and store information today will achieve effective retrieval in the future” “Traceability back to the raw data needs to be done in an efficient and effective timeframe”

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SLIDE 7

24 Hour Challenge

  • The focus is on
  • Governance
  • Behaviours
  • Audit/Metrics
  • Stakeholder Management
  • Process

Good Information Management

This is not a technology response although the end point may need to have technology element

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SLIDE 8

Governance

  • Governance is key to delivering the change required
  • This spans across R&D and operations
  • This has meant sponsorship from a Senior

Executive Team level

  • The changing landscape of the industry means that

we need to maintain our focus on the traceability of regulatory knowledge and information

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SLIDE 9

Governance

  • Compliance to policy relating to Regulatory

Knowledge

  • Day to day adherence to definitions
  • Understanding of internal and external drivers
  • Tactical responses
  • Strategic Roadmap to deliver towards vision
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SLIDE 10

Communication and Behaviours

  • Behavioural changes across a large
  • rganisation can be daunting
  • Communication plan has focused every

individual

  • SET
  • Leadership teams
  • Functional Areas
  • Individuals
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SLIDE 11

Communication and Behaviours

  • Message around the effective creation

storage and retrieval of our products throughout it’s lifecycle

  • Posters
  • Training and awareness sessions
  • Videos
  • Portal
  • Newsletters
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SLIDE 12

Audit and Metrics

  • Already have many projects focussed on improving

the submission of a product

  • There is also a focus here on the approval and

lifecycle of a product

  • To gain and measure success:
  • Mapping out our current information flows
  • Looking at route cause problems
  • Providing a vision as to where we want to be
  • Build in Measures
  • Audit our compliance to policy
  • Put in controls
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SLIDE 13

Stakeholder Management & Buy-in

  • Everyone in R&D and operations is a stakeholder
  • Establish decision makers and blockers
  • Continuously manage stakeholders
  • Buy-in needs to be documented and communicated
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SLIDE 14

Information Principles

  • “Information is information”
  • Data, Information, Knowledge used interchangeably

Label Conclusions Analysis/Summary Raw Data

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SLIDE 15

Information Principles

  • Should be more information focussed not document

focussed

  • This will allow better traceability back to the raw

data from any summary or conclusion

  • Need to support statements in label:
  • 1. Safety
  • 2. Efficacy
  • 3. Quality
  • 4. Patient Population
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SLIDE 16

Conclusions

  • To be more effective in management regulatory

knowledge and information

  • Governance
  • Behaviours
  • Information Maturity
  • Traceability of data, information, knowledge and wisdom
  • Our ultimate measure to success is to have no questions

back from the authorities

  • High quality of information supporting the label
  • Faster approval
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SLIDE 17

Thankyou

24 Hour Challenge PhUSE 09

Accelerating Clinical Development

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SLIDE 18

Ice-Breaker Catch Phrase

1

The Left Dark Uckly Lkylu Lucky Punch

No No No No No No No

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