Good Pharmacovigilance Practice Discussion Forum

• SUSAR Reporting

  Ekkehard Herpers

  Mian (23/06/2019)

  2
• SAE reporting in clinical trial

  Anon

  Mian (23/06/2019)

  3
• Entering suspect drugs into database

  Caroline Ahmed

  Caroline Ahmed (28/05/2019)

  0
• Short format DSUR for Type A trials - Due dates

  Paula

  Paula (08/05/2019)

  0
• Medical Evalaution on Medically significant/IME

  Anshu Tomar

  ravindra honrao (03/05/2019)

  4
• AE "worsening of underlying disease" not reportabel per study protocol. What to do if event fulfills Seriousness criteria?

  Nanda Brattinga-van Roekel

  Ravindra Honrao (03/05/2019)

  2
• Client/ Distributor PVAs

  Kashmira Gupte

  D Chesnais (26/04/2019)

  1
• Does an LMS need to be 21 CFR Part 11 compliant

  Michael

  Trev Simmons (DIGIT) (25/04/2019)

  4
• PV in Russia

  Nina

  Nina (23/04/2019)

  0
• ICSR Medical review

  Alan Wesley

  D Chesnais (19/04/2019)

  1