Good Pharmacovigilance Practice Discussion Forum

• ICSR Medical review

  Alan Wesley

  D Chesnais (19/04/2019)

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

  Nanda Brattinga-van Roekel

  Nanda Brattinga-van Roekel (15/04/2019)

  0
• Risk Assessment Criteria for PV Audits

  David

  Dan (29/03/2019)

  3
• Creating a QMS from the ground up

  Hannah

  GMP Committee (08/03/2019)

  5
• Client/ Distributor PVAs

  Kashmira Gupte

  Kashmira Gupte (07/03/2019)

  0
• CTR implementation in UK and Europr

  Jan

  Anon (25/02/2019)

  3
• Medical Evalaution on Medically significant/IME

  Anshu Tomar

  nihal` (31/01/2019)

  3
• CAPA Verification

  Anon

  RICHARD LAURENCE (21/01/2019)

  1
• scope in clinical research

  vaibhav raj kapoor

  danish (04/12/2018)

  3
• Adverse Events "Unlikely"

  Diana

  Anon (17/09/2018)

  4
• GDPR in Pharmacovigilance

  Hari

  Almas (10/09/2018)

  2
• Editable closed case

  Anon

  Shaun Hastings (23/08/2018)

  1
• Does an LMS need to be 21 CFR Part 11 compliant

  Michael

  Matt Jones - Chair, DIGIT Committee (03/06/2018)

  1
• Grading of findings

  Anu

  RQA GLP Committee (04/05/2018)

  4
• SAE reporting in clinical trial

  Anon

  D. Chesnais (04/04/2018)

  2
• Rechallenge Assessment - Tratment intervention for entry of Rechallenge

  Anonymous

  RQA GPvP Committee (21/03/2018)

  1
• Source data in pharmacovigilance

  anon

  RQA GPvP Committee (20/03/2018)

  1
• Pharmacovigilance audits for Medical Device

  Anoynomous

  RQA GPvP Committee (18/03/2018)

  2
• Safety reporting to Chinese FDA

  ANON

  RQA GPvP Committee (18/03/2018)

  1
• Local Literature review - ICSRs AND Articles of interest?

  anon

  RQA GPvP Committee (18/03/2018)

  2

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