Good Pharmacovigilance Practice Discussion Forum

• Inclusion of vendor's internal process audits in PSMF

  S Dean

  Paul Shillito (RQA PV Committee) (02/12/2021)

  2
• Is the PSMF global despite MAH status

  Nina

  Paul Shillito (RQA PV Committee) (02/12/2021)

  1
• Correct end date of a Serious Adverse Event

  Nadine Roethling

  Naveed (27/10/2021)

  1
• AE "worsening of underlying disease" not reportabel per study protocol. What to do if event fulfills Seriousness criteria?

  Nanda Brattinga-van Roekel

  paul keown (20/10/2021)

  3
• RoW in Pharmacovigilance

  anonymous

  anonymous (16/10/2021)

  0
• How long do you have to wait to start using updated IB (RSI) when no RA approval received?

  Nanda van Roekel

  Nanda van Roekel (04/10/2021)

  0
• Armed or Alarmed? Share your thoughts on alert management, and how you manage EUFMD alerts as a pharma manufacturer by completing this survey

  EU ALERT MANAGEMENT SURVEY

  EU ALERT MANAGEMENT SURVEY (27/09/2021)

  0
• Average number of calendar days - Audit query (distribution & CAPA Plan response)

  Crystal Dart

  Andrea Berardi (16/09/2021)

  1
• Telephone Land line requirements globally

  Crystal Dart

  Crystal Dart (09/09/2021)

  0
• Remote pharmacovigilance inspections of MAHs

  Dominique Chesnais

  Colin Wilsher (28/07/2021)

  3
• SUSAR Reporting Requirements in RUSSIA

  Silvia Palau

  Dominique Chesnais (26/07/2021)

  1
• GVP Auditor in Australia

  Sophie Moya

  Sophie Moya (06/07/2021)

  0
• Safety data collection after subject withdrawal

  Anon

  Pubrica healthcare (16/06/2021)

  2
• Medical Evalaution on Medically significant/IME

  Anshu Tomar

  Pubrica healthcare (16/06/2021)

  11
• GVP Auditor in China?

  Raquel Pensado

  Dominique Chesnais (03/05/2021)

  1
• Distributed Manufacturing

  Jennifer Bell

  Jennifer Bell (27/04/2021)

  0
• 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
• PMDA Japan shares process for certain remote compliance inspections

  Aldwin Aldana

  Juergen Kaetzler (01/02/2021)

  2

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