<Draft> Issues Analysis Summary

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Contact: Policy Bureau Enquiries

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Template Date August 2007

<Name of Issue>

Therapeutic Products Directorate/Biologics and Genetic Therapies Directorate

Contents

• 1 Issue
• 2 Purpose/Objective
• 3 Background and Issue Analysis
• 4 Options Analysis
  • 4.1 Issue #1
  • 4.2 Issue #2
  • 4.3 Other Considerations
• 5 Consultations
  • 5.1 Internal Consultations
  • 5.2 External Consultations
• 6 Recommendations
• 7 Implementation and Evaluation Plans
• 8 References
• Appendices

Note that it is reasonable to assume that the issue analysis associated with detailed, scientific guidance documents may be more straightforward than that associated with broader, more complex issues dealing with multiple areas of expertise.

1 Issue

State a brief definition of the issue, from SOP #1 (Issue Analysis in TPD/BGTD), Step 3.

2 Purpose/Objective

State the purpose or objective of the issue analysis that has been undertaken.

3 Background and Issue Analysis

Give a brief history of the background - what initiated the analysis of this issue? Has previous work been done on this issue?

Describe how the project developed - was a working group formed?

Describe the analysis of the issue itself, conducted in SOP #1 (Issue Analysis in TPD/BGTD), Step 7.

4 Options Analysis

For each component of the issue (or topic, or sub-project), describe the topic, and the options for resolution. For each option, describe the analysis, and finish with the recommendation for that topic. Refer to SOP #1 (Issue Analysis in TPD/BGTD) for detailed instructions on the options analysis.

4.1 Issue #1

Option A
Description of Option
Analysis of Option
Recommendation

Option B
Description of Option
Analysis of Option
Recommendation

4.2 Issue #2

Option A
Description of Option
Analysis of Option
Recommendation

Option B
Description of Option
Analysis of Option
Recommendation

4.3 Other Considerations

Describe any other considerations that factored into the recommendations - for example, the international situation, any ongoing projects or initiatives that may impact on this project (or vice versa), etc.

5 Consultations

5.1 Internal Consultations

Comments may be addressed using the Summary of consultations table template located in Chapter 5 of the GGP Manual. This can be incorporated into the IAS as an Appendix. Similar comments should be grouped where possible. Attribution numbers are not necessary for internal comments but may be used if valuable (e.g. comments could be attributed to groups of people, i.e. reviewers, managers, etc.).

5.2 External Consultations

Comments may be addressed using the Summary of consultations table template located in Chapter 5 of the GGP Manual. This can be incorporated into the IAS as an Appendix. Similar comments should be grouped where possible. Attribution numbers are not necessary but may be used if valuable (e.g. comments can be attributed to pharmaceutical industry, industry associations, patient associations, regulatory authorities, etc.).

6 Recommendations

Summarize the recommendations. What are the next steps? (E.g. DMC approval of the recommendations, followed by internal or external consultation, or implementation.)

7 Implementation and Evaluation Plans

Describe the plan for implementation of the recommendations, including time lines. Will training be a component of implementation? An implementation plan (template located in Chapter 5 of the GGP Manual) may be drafted separately and referenced here.

Describe the plan for evaluating the success of the recommendations if accepted.

8 References

Appendices