Good Pharmacovigilance Practice Discussion Forum

Please ensure you are logged in to the website in order to post in the forum.

• Risk Management during CT

  anonymous

  Rathod (23/02/2021)

  2
• [FREE]: US FDA CDER Small Business and Industry Assistance (SBIA) Learn Online Training Repository

  Aldwin Aldana

  Aldwin Aldana (16/02/2021)

  0
• Medical Evalaution on Medically significant/IME

  Anshu Tomar

  Nick (13/02/2021)

  10
• Safety data collection after subject withdrawal

  Anon

  Anon (11/02/2021)

  0
• PMDA Japan shares process for certain remote compliance inspections

  Aldwin Aldana

  Juergen Kaetzler (01/02/2021)

  2
• Correct end date of a Serious Adverse Event

  Nadine Roethling

  Nadine Roethling (13/12/2020)

  0
• Does an LMS need to be 21 CFR Part 11 compliant

  Michael

  Anon (27/11/2020)

  5
• New IB version with updated RSI approved by CA, rejected by EC. Expedited reporting SUSAR

  Nanda Brattinga

  Dominique Chesnais (17/10/2020)

  1
• Deriving safety concerns from RSI (CDS/SmPC/PI)

  anonymous

  anonymous (02/10/2020)

  0
• MHRA: New rules for January 2021

  Dominique Chesnais

  Dominique Chesnais (02/09/2020)

  0