Good Pharmacovigilance Practice Discussion Forum

• 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
• Reporting SAE at screening

  QA Consultant

  Henrieke (07/06/2020)

  2
• Practical guidance of the CMDh

  Dominique Chesnais

  Dominique Chesnais (24/04/2020)

  0
• ICMRA meeting: COVID-19 Real-World Evidence and Observational studies

  Dominique Chesnais

  Dominique Chesnais (17/04/2020)

  0
• PhV training in the field of clinical trials

  Jordi

  Jordi (15/04/2020)

  4
• COVID-19 pandemic pharmacoepidemiological studies reported in the EU PAS Register (EMA)

  Dominique Chesnais

  Dominique Chesnais (31/03/2020)

  0
• SUSARs notification to Principal Investigators

  Ana

  D Chesnais (28/01/2020)

  7
• ADR Submission USA

  nt

  nt (17/12/2019)

  0
• ICSR submission Timeline-calculation of 15 calendar days

  Gayathri S

  Gayathri S (02/12/2019)

  0

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