Good Pharmacovigilance Practice Discussion Forum

• 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
• Entering suspect drugs into database

  Caroline Ahmed

  Caroline Ahmed (28/05/2019)

  0
• Short format DSUR for Type A trials - Due dates

  Paula

  Paula (08/05/2019)

  0
• AE "worsening of underlying disease" not reportabel per study protocol. What to do if event fulfills Seriousness criteria?

  Nanda Brattinga-van Roekel

  Ravindra Honrao (03/05/2019)

  2
• Client/ Distributor PVAs

  Kashmira Gupte

  D Chesnais (26/04/2019)

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

  Michael

  Trev Simmons (DIGIT) (25/04/2019)

  4
• PV in Russia

  Nina

  Nina (23/04/2019)

  0
• ICSR Medical review

  Alan Wesley

  D Chesnais (19/04/2019)

  1
• Risk Assessment Criteria for PV Audits

  David

  Dan (29/03/2019)

  3

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