Developing the Chemical and Regulatory International Strategic Plan (CRISP)

  1. Critical Success Factors for the CRISP
    • Defining the Goals
    • FOCUS
  2. Outlining the Clinical Plan Defining the Product Profile
    • Choosing the Target Indication and Patient Population
    • Annotated Labeling as a Planning Tool
  3. Defining the Regulatory Strategy
    • Location, Location, Location: Choosing Sites for Clinical Trials
    • Country Requirements for Initiating Clinical Trials
  4. Critical Questions for Phases 1, 2, and 3
    • Selecting Key Investigators
    • First in "Man"/Proof of Principle
    • Early Efficacy Trials
    • Pivotal Studies
    • Phase IV

 

 

  1. The Clinical Dossier
    • Defining Preclinical Requirements to Support the Clinical Program
    • IND Item 6
      - The Investigator's Brochure
      - The Protocol and Informed Consent
      - Planning for Support of the Package   Insert
    • CTD Summarien and Module 5
  2. Recent Changes
    • Financial Disclosure
    • Pediatric Trials
  3. NDA's, MAA's and the Common Technical Document
    • Organization and Content
      - The Submissions
      - The US Package Insert (PI) versus the EU   Summary of Product Characteristics   (SmPC)
    • US and EU Clinical Guidance Documents