Strategy of Implementation

1
Strategy of Implementation

• IV Pan American Conference on Drug Regulatory
  Harmonization Dominican Republic2-4 March 2005

2
Background

• PhRMA and FDA developed a pilot methodology to
  assess the implementation, application and
  utilization of ICH guidelines
• The approach was a simple, process-based
  assessment of guideline implementation
• It was apparent that there are a number of
  general systems that need to be in place both at
  a regulatory and industry level to successfully
  implement any regulatory guideline

3
Value of Tool

• The tool provides both a measure of how
  guidelines will be implemented, and what may be
  done by regulatory agencies and industry to
  improve their own systems of implementation
• May also be used as a diagnostic when
  implementation issues occur
• System-level approach will help determine problem
  area needing corrective action

4
Implementation Process Flow
Implementation Step
Process
Actions
Topic Selection
Good guideline topicselection
Guideline must be value- added and
implementable
Dissemination
Formal communicationprocess
Use multiple avenues
Publication
Active distribution
Targeted via meetingsalso non-PANDRH groups
Training
Educating users
Early, often, all within andacross
organizations
Implementation
Putting guideline theory into practice
Integrated process-address questions/issues
Management
Active monitoringof utilization
Feedback to PANDRH SC
5
Selection of Topics

• Successful implementation is predicated on
  selection of good topics for guideline
  development
• Key criteria for topic selection include
• Is there a clear need for harmonization?
• Will the new guideline improve add valuable
  quality, safety or efficacy standards?
• Will the new guideline decrease redundancy in
  drug development?
• Does the guideline have a specific/technical
  focus?
• Is the guideline relevant and applicable to all
  parties?

6
Publication

• There must be a formal process to communicate a
  completed guideline
• Communication must be undertaken using multiple
  avenues
• Journals
• Websites
• Meetings

7
Dissemination

• There must be an active process of distributing
  and increasing awareness of a completed guideline
• Approved guidance must be processed through local
  regulatory procedures
• The guideline should be distributed to targeted
  stakeholders
• The guideline should be discussed at relevant
  international, national and local meetings and
  conferences

8
Training

• All those using the guideline must be educated on
  what the guideline means and how to employ the
  guideline
• Training must be inclusive-early, often, all
• Should be open to all stakeholders
• Open access to all information
• Goal is increased comfort level with change
  brought about by guideline

9
Training

• There should be adequate advanced notice of
  educational forums, seminars, workshops
• Training should be targeted to appropriate
  audiences
• There should be cross training between
  regulators and industry
• There should be training within organizations
• A mechanism should be established to address
  questionswithin and across stakeholders

10
Implementation

• Putting the guideline into practice
• The appropriate authorities (both industry and
  regulators) should manage the implementation plan
• It is important to continue to communicate
  awareness about the guideline at the local and
  regional level
• Appropriate resources should be allocated to
  implementation (time, personnel, money)

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Implementation

• Implementation is as, if not more important, than
  guideline development itself
• During implementation, it is important to
  recognize the need to integrate any related
  guidelines
• A mechanism should be put in place to identify
  issues that were overlooked or changing science

12
Management

• There should be active monitoring of the
  utilization of guidelines
• Regular communication and cooperative feedback in
  necessary
• An annual report by all parties should be
  undertaken which details discrepancies between
  ideal and actual implementation processes
• Mechanisms must be established to correct gaps in
  a guideline in a timely fashion
• Continuing education is important

13
Implementation Process Flow
Implementation Step
Process
Actions
Topic Selection
Good guideline topicselection
Guideline must be value- added and
implementable
Dissemination
Formal communicationprocess
Use multiple avenues
Publication
Active distribution
Targeted via meetingsalso non-PANDRH groups
Training
Educating users
Early, often, all within andacross
organizations
Implementation
Putting guideline theory into practice
Integrated process-address questions/issues
Management
Active monitoringof utilization
Feedback to PANDRH SC
14
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