Regulatory Task & Deadline Management Template

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In the pharmaceutical industry, regulatory compliance is crucial for the success of research and trials. This template helps Sr. Medical Science Liaisons manage and track regulatory tasks and deadlines efficiently.

By using this template, you can ensure timely compliance with all necessary regulations, thereby maintaining the integrity and progress of your research activities.

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Regulatory Task & Deadline Management for Priority Matrix

Regulatory Task & Deadline Management in Priority Matrix

Keep track of regulatory tasks and deadlines to ensure compliance in research and trials.

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Proposed Tasks

High Impact, Urgent

  • Task 18: Prepare for Regulatory Inspection - Due in 13 months
    ☐ Review Previous Inspection Reports ☐ Prepare Inspection Plan ☐ Implement Plan
  • Task 1: Submit Trial Protocol for Approval - Due in 1 week
    ☐ Prepare Trial Protocol ☐ Review Protocol ☐ Submit Protocol
  • Task 2: Schedule Regular Compliance Audits - Due in 2 weeks
    ☐ Identify Compliance Parameters ☐ Set Audit Schedule ☐ Inform Relevant Teams
  • Task 5: Prepare for Upcoming Inspection - Due in 6 weeks
    ☐ Review Previous Inspection Reports ☐ Identify Areas of Improvement ☐ Implement Improvements
  • Task 8: Prepare Annual Report - Due in 3 months
    ☐ Collect Data ☐ Prepare Report ☐ Review Report
  • Task 14: Prepare for Clinical Trial Audit - Due in 9 months
    ☐ Review Previous Audit Reports ☐ Prepare Audit Plan ☐ Implement Plan

High Impact, Non-Urgent

  • Task 19: Review Data Management Plan - Due in 14 months
    ☐ Identify Data Management Requirements ☐ Review Plan ☐ Identify Areas of Improvement
  • Task 20: Update Clinical Trial Agreements - Due in 15 months
    ☐ Identify Agreement Requirements ☐ Update Agreements ☐ Review Agreements
  • Task 3: Review Regulatory Changes - Due in 3 weeks
    ☐ Identify Sources of Regulatory Changes ☐ Review Changes ☐ Identify Impact on Operations
  • Task 4: Update Compliance Training - Due in 1 month
    ☐ Identify Training Needs ☐ Update Training Materials ☐ Schedule Training
  • Task 6: Update Clinical Trial Data Management System - Due in 2 months
    ☐ Identify System Updates ☐ Test Updates ☐ Implement Updates
  • Task 7: Review New Drug Application (NDA) Requirements - Due in 10 weeks
    ☐ Identify NDA Requirements ☐ Review Requirements ☐ Identify Impact on Operations
  • Task 9: Review Device Classification - Due in 4 months
    ☐ Identify Device Classification Requirements ☐ Review Classification ☐ Identify Impact on Operations
  • Task 10: Update Safety Reporting Procedures - Due in 5 months
    ☐ Identify Safety Reporting Requirements ☐ Update Procedures ☐ Inform Relevant Teams
  • Task 11: Review Adverse Event Reporting - Due in 6 months
    ☐ Identify Reporting Requirements ☐ Review Current Reporting ☐ Identify Areas of Improvement
  • Task 12: Update Risk Management Plan - Due in 7 months
    ☐ Identify Risk Management Requirements ☐ Update Plan ☐ Review Plan
  • Task 13: Review Quality Management System - Due in 8 months
    ☐ Identify Quality Management Requirements ☐ Review System ☐ Identify Areas of Improvement
  • Task 15: Update Investigator's Brochure - Due in 10 months
    ☐ Identify Brochure Requirements ☐ Update Brochure ☐ Review Brochure
  • Task 16: Review Clinical Trial Protocols - Due in 11 months
    ☐ Identify Protocol Requirements ☐ Review Protocols ☐ Identify Areas of Improvement
  • Task 17: Update Informed Consent Forms - Due in 1 year
    ☐ Identify Form Requirements ☐ Update Forms ☐ Review Forms