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Online

06 jun 2017 11:00 a.m. - 08 jun 2017 1:00 p.m.

How to Prepare for a Safety Inspection

Part 3: Module 6, Module 7, and Module 8

Session Chair(s)

Jennifer  Kane, BSN, RN

Jennifer Kane, BSN, RN

Head of Pharmacovigilance

Flexion Therapeutics, United States

Module 6 - What You Really Have to Do

  • General Considerations
  • Roles and Responsibilities - Preparation for Inspections
  • Preparation for Future Inspection
Module 7 - Behavior, Advice, and Comments
  • Demonstration of different behaviors and interviewee response types
  • The Park Doctrine
Module 8 - Case Studies

Exercise

Q&A, Summary and Conclusions

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