Details
– Understanding aggregate modules-GPV-7.
-Why it E14:E18is important to follow it.
-What is PBRER, PSURs, DSUR & ACO. Detailed outline of different sections.
-How to author different sections of PBRER with examples.
-How to draft Request for Information for different Reports
-What is Reference Safety Information (RSI). Covering detailed information on different sections of RSI.
-How to interpret Risks from RSI.How to analyse Aggregate Line Listings (LL).
-How to develop search strategies for Safety topics/Risks. Importance of MedDRA SMQ.
-How to retrieve cases pertaining to Risks from Aggregate LL.
-Guidance on PBRER Template
-Participants to author mock reports for better understanding of PBRER
-Assignment of 3-4 different mock reports
-Doubt clearing sessions
Outline
– Understanding aggregate modules-GPV-7.
-Why it E14:E18is important to follow it.
-What is PBRER, PSURs, DSUR & ACO. Detailed outline of different sections.
-How to author different sections of PBRER with examples.
-How to draft Request for Information for different Reports
-What is Reference Safety Information (RSI). Covering detailed information on different sections of RSI.
-How to interpret Risks from RSI.How to analyse Aggregate Line Listings (LL).
-How to develop search strategies for Safety topics/Risks. Importance of MedDRA SMQ.
-How to retrieve cases pertaining to Risks from Aggregate LL.
-Guidance on PBRER Template
-Participants to author mock reports for better understanding of PBRER
-Assignment of 3-4 different mock reports
-Doubt clearing sessions
Speaker/s
The primary focus area of Pharmamentor is Pharmacovigilance and safety writing Trainings.
Pharmamentors offers 3 main courses Pharmacovigilance training for beginners, Safety Writing- Aggregate Reports, Safety Writing-Signal Detection.
Training remains the focus to generate quality industry skillset to meet the global requirement in the field of Pharmacovigilance, Medical Writing, Clinical Research and Regulatory Affairs.
Our key strengths include service excellence, quality management, strict adherence and compliance to Regulatory guidelines, cost effectiveness and thorough understanding of local and global regulatory policies and processes.
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