Good Pharmacovigilance Practice Discussion Forum

• Reporting SAE at screening

  QA Consultant

  Dominique Chesnais (30/05/2020)

  1
• Minutes from affiliate PV/RA meetings

  tina

  tina (14/05/2020)

  0
• 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
• Query about expedited reporting.

  Manoj Swaminathan

  Manoj Swaminathan (11/10/2019)

  0
• SUSAR cover letter

  Eleonora

  Anon (10/10/2019)

  1
• GVP Deviations Categorization

  Raquel Pensado

  Manoj Swaminathan (10/10/2019)

  1
• Safety Database - Audit Trail Review

  Manoj Swaminathan

  Manoj Swaminathan (10/10/2019)

  2
• Potential Signal Vs Noise

  Manoj Swaminathan

  Manoj Swaminathan (06/10/2019)

  0
• Medical Evalaution on Medically significant/IME

  Anshu Tomar

  Manoj Swaminathan (30/09/2019)

  6
• Pharmacovigilance Auditor Training

  Deepak

  Manoj Swaminathan (30/09/2019)

  1
• Incidental AEs in HCP/ patient interactions

  John

  John B (03/09/2019)

  1
• DSUR/PBRER

  Priya G

  Priya G (23/08/2019)

  0
• SUSAR Reporting

  Ekkehard Herpers

  Mian (23/06/2019)

  2
• SAE reporting in clinical trial

  Anon

  Mian (23/06/2019)

  3

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