Drug Safety Strengthened by Technology and Data Integrity
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Drug Safety Strengthened by Technology and Data Integrity Lisa Olson, SEC Associates, Inc. FDA Regulatory & Compliance Symposium Cambridge, August 26, 2005. Agenda?. What's Going on Now? Some Problem Areas What's Changing? How is Risk Manifested? Important Focus

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Fda regulatory compliance symposium cambridge august 26 2005

Drug Safety Strengthened by Technology and Data Integrity

Lisa Olson, SEC Associates, Inc.

FDA Regulatory & Compliance Symposium

Cambridge, August 26, 2005


Agenda

Agenda?

  • What's Going on Now?

  • Some Problem Areas

  • What's Changing?

  • How is Risk Manifested?

  • Important Focus

  • Business Value of Accurate Systems


Fda regulatory compliance symposium cambridge august 26 2005

What's Going On Now?


Current environment

Current Environment

  • Product problems

  • Need to see early signals

  • Increasing interactions

    • Multiple chronic conditions

    • Insurance promoting the "quick fix" (drug)

  • Physicians are rushed


Current environment1

Current Environment

  • Pressures

    • Congress

    • Patient

    • Industry

    • Various organizations (trade, patient advocacy, disease research)

  • Need/want to look at safety from research through to manufacturing and use


Current environment2

Current Environment

  • FDA

    • Wants to partner with industry

    • Pressure to get drugs to market quickly

    • Yet, under scrutiny for not protecting the public

  • Industry

    • Economic and competitive pressures

    • Bad press

    • Changing the way we approach therapies (more individualized)


Current environment3

Current Environment

  • Move towards electronic health records

  • Almost too much information to analyze – large amount of data

  • Computer usage increasing – storage, capture, analysis

  • Reliance on automation is increasing

  • Safety measures change and may be electronic (ECGs, specialty labs)


Current environment4

Current Environment

AGHGHG!!

  • Reduce risks or deal with appropriately throughout life cycle of the product

  • Want to be able to look at data cross-program

  • Increased interest in quick solutions


Fda regulatory compliance symposium cambridge august 26 2005

Some Problem Areas


Problem areas

Problem Areas

  • Wide variety of "solutions"

  • Systems don't talk to each other

  • Increased outsourcing

  • More information coming from multiple parties


Problem areas in research

Problem Areas in Research

  • Separation of drug safety data from clinical data management (reconciliation task)

  • We do QA of CDM – what about SAEs, PVG?

    • What checks are done on the data?

    • What about coding – is it accurate?

    • Versions of dictionaries?

  • Any check that periodic safety reports are correct?


Problem areas1

Problem Areas

  • We focus on accuracy of collection – what about the analysis?

  • Need to ensure availability of data

These problems are solvable, but you do need to address them


Fda regulatory compliance symposium cambridge august 26 2005

What's Changing?


Critical path

Critical Path

  • FDA's Critical Path Initiative

  • Make right decisions based on reliable data

  • Need better assessment of safety early on

  • Use new technology, but take care with it

  • Look at data cross-company (need for standards)

  • Want to be able to analyze data quickly, but watch out for bias which could invalidate study


What s different

What's Different

  • Data mining will be critical

    • Ability to slice and dice

    • Ability to quickly aggregate

    • But must be accurate

    • Hard to mine, if in multiple places

  • Health (medical) records vs. clinical trial records – can they be the same?


What s different1

What's Different

  • Importance of PAT – finding a process or measurement problem that might cross products

  • Consider infrastructure that is needed

    • Staff roles changing

    • QA staff vs. scientists

    • Computer security

    • Analysis tools – training!


Fda regulatory compliance symposium cambridge august 26 2005

How is Risk Manifested?


Fda regulatory compliance symposium cambridge august 26 2005

Risk

  • Wrong decisions based on bad data

  • Data being changed inappropriately

  • Misrepresented results (not necessarily an error message!)

  • Unavailability of data/records

    • Technology issues

    • Training


Fda regulatory compliance symposium cambridge august 26 2005

Risk

To Patient?

Or risk of getting caught?


Fda regulatory compliance symposium cambridge august 26 2005

Important Focus


Realize impact of

Realize Impact of:

  • Inaccurate software

  • Incorrect use

  • Control over changes

  • Integrity controls

  • Security


What else is important

What Else Is Important

  • Employing the right skills

  • Auditing/verifying suppliers – know what you're buying!

  • Compliance (this is implied, but maybe shouldn't be)

    • Clinical investigators

  • Compliance is everyone's responsibility

    • All uses

    • All analyses


Fda regulatory compliance symposium cambridge august 26 2005

Business Value of Accurate Systems


The v word

The "V" Word

What does "validation" mean?

Simply, is it working correctly? (And can you prove it?)

Why is this a bad thing?


Validation

Validation

  • Arguments:

    • "It takes too long – let's just put it in and fix it later"

    • "I'm buying it – the vendor should ensure it's correct"

    • "Nobody else is doing this"

    • "We won't get inspected"

    • "We'll know if it's not working"


A contradiction

A Contradiction

  • We are tending to trust computers more at a time when:

    • Impact of software bugs is greater

    • Timelines are too short to build in quality

    • We are trying to link incompatible things together

    • Security exposures are increasing

    • We are using other companies (and their systems) to do our processes, without adequate investigation


Value

Value

  • Get things right the first time (more expensive to fix and patch)

  • Decrease overall costs of system deployments

  • Avoid making wrong decisions based on incorrect data


Value1

Value

  • "Hidden" costs

    • Company reputation

    • Staff confidence

  • Partner with suppliers – get better products

  • Minimize risks – appropriate mitigation

  • React vs. prevent

  • Not an add-on; just part of your business


Fda regulatory compliance symposium cambridge august 26 2005

In Summary


In summary

In Summary

  • For safety, remember the importance of:

    • Accurate data

    • The right data

    • Availability / timeliness

  • Use technology, but make sure it's right!


Fda regulatory compliance symposium cambridge august 26 2005

Thank You!

Lisa Olson

Principal Consultant

SEC Associates, Inc.

2100 Gateway Centre Blvd., Suite 150

Morrisville, NC 27560

Phone: (919) 532-1241

Fax: (919) 467-1109

[email protected]


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