Good Pharmacovigilance Practice Discussion Forum

• SUSARs notification to Principal Investigators

  Ana

  Marko (25/03/2021)

  11
• Day Zero

  Kerry Bunyan

  Kerry Bunyan (22/03/2021)

  0
• [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
• Risk Management during CT

  anonymous

  Dominique Chesnais (02/10/2020)

  1
• MHRA: New rules for January 2021

  Dominique Chesnais

  Dominique Chesnais (02/09/2020)

  0
• MHRA: Guidance on pharmacovigilance procedures in the event from 1 January 2021

  Dominique Chesnais

  Dominique Chesnais (02/09/2020)

  0
• Potential Signal Vs Noise

  Manoj Swaminathan

  Manoj Swaminathan (14/08/2020)

  3
• Cross-reporting SUSARs received from MAH to Investigators

  Nanda

  Dominique Chesnais (31/07/2020)

  1
• EMEA reporting

  Anon

  Dominique Chesnais (30/07/2020)

  3
• Pharmacovigilance Audit Reports

  Sophie Moya

  Sophie Moya (20/07/2020)

  4
• PSP qualification and oversight

  Frederique Roesch

  Frederique Roesch (02/07/2020)

  0
• GPvP training to all employees?

  anonymous

  Dominique Chesnais (01/07/2020)

  2
• Minutes from affiliate PV/RA meetings

  tina

  Tina (20/06/2020)

  2

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