Event Calendar

Agenda

Day 1

8:00 am / 2:00 pm - Welcome and Expectations (1 CE)

  • What is "good clinical practice"
  • The "spirit" of the conference
  • Great change in the Industry
  • Pharma Industry overview/drug approval process

9:00 am / 3:00 pm - Good Clinical Practice: Obligations of the Sponsor and Monitor (1.25 CE)

  • Basic Principals
  • International Conference on Harmonization
  • Investigator's Responsibilities
  • Monitor's Responsibilities
  • Company SOPs
  • Record Retention

 10:15 am / 4:15 pm - Break

 10:30 pm / 4:30 pm - Ethical Considerations (1.25 CE)

  • Institutional Review Boards
  • Informed Consents
  • Financial Disclosure
 Day 2

8:00 am / 2:00 pm - Investigator Recruitment and Selection (1.25 CE)

  • Investigator Recruitment
  • Potential Investigative Sites
  • Investigator Selection Factors
  • Site Selection Visits

9:15 am / 3:15 pm Study Start-Up and Site Initiation Activities (15 min break) (1.5 CE) 

  • Essential Documents
  • Site Initiation
  • Subject Recruitment Planning

10:45 am / 4:45 pm - Monitoring Activities and Site Visits (1.25 CE) 

  • Purpose
  • Preparation
  • On-site Document Review
  • Visit Summary with Study Personnel
  • Visit Report and Follow-up
  • Monitoring Activities
Day 3

8:00 am / 2:00 pm - Monitoring Activities and Site Visits (continued) (2 CE)

  • Case Studies
  • Exercises

10:00 am / 4:00 pm - Break

10:15 am / 4:15 pm - Risk Based Monitoring (1.75 CE)

  •  Definition of risk based monitoring
  • Rationale for change to risk based monitoring
  • Implementation of risk based monitoring by Sponsors
  • Site strategies to navigate this change in monitoring process
 Day 4


8:00 am / 2:00 pm - Risk Based Monitoring (continued) (1 CE)

9:00 am / 3:00 pm - Quality Assurance Audit (1 CE)

  • Difference between Auditing and Monitoring
  • Sponsor Audits
  • Preparing for an Audit
  • FDA Inspections
  • FDA Warning Letters
  • QA Exercise

 10:00 am / 4:00 pm - Break

10:15 / 4:15 pm - Case Studies (1.75)