Good Pharmacovigilance Practice Discussion Forum

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Correct end date of a Serious Adverse Event

Nadine Roethling

Nadine Roethling (13/12/2020)

0
Does an LMS need to be 21 CFR Part 11 compliant

Michael

Anon (27/11/2020)

5
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

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