Good Pharmacovigilance Practice Discussion Forum

• 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
• GDPR in Pharmacovigilance

  Hari

  Hari (23/04/2018)

  0
• 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
• Medical Evalaution on Medically significant/IME

  Anshu Tomar

  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
• Compliance % and/or delays limit acceptable for ICSR submission

  Anshu Tomar

  Anshu Tomar (26/01/2018)

  2
• Missed Dose?

  Anonymous

  Anon user (08/12/2017)

  2
• Vendor Qualification Audit

  Anu

  RQA GLP Committee (08/09/2017)

  2
• Safety Officer

  Emma

  Emma (01/09/2017)

  0
• Follow-ups

  Anon

  GPvP Committee (17/05/2017)

  1
• Reporting Rules

  Anon

  GPvP Committee (31/01/2017)

  1
• PV Partner Agreements

  nbt

  GPvP Committee (17/01/2017)

  1
• Medical Monitoring Procedures

  Anon

  GPvP Committee (27/10/2016)

  1
• Risk Assessment Criteria for PV Audits

  David

  GPvP Committee (15/07/2016)

  2
• Medical review

  Nina Toubro

  GPvP Committee (13/07/2016)

  1

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