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Signal Detection- (Qualitative & Quantitative)

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On-Site / Training
Jul 18, 2021 - Sep 19, 2021
INR  59,000.00

Details

-What is Signal and why it is important in PV.

-Different Sources of Signal.

-Different Signal Approaches- Qualitative & Quantitative Methods

-In-depth understanding of Signal Detection, Validation, Assessment & Prioritization with different scenarios covering Drug-Event Pair

-What is EVDAS & FAERS methods of Signal Detection

-What is next steps post Signal Assessments

-Causality Assessment & Interpretation

-What is Reference Safety Information (RSI). Covering detailed information on different sections of RSI

-How to analyse Signal Line Listings (LL). How to develop search strategies for Safety topics/Risks. Importance of MedDRA SMQ.

-Empirica Signal Guidance

-Guidance on Signal TemplateParticipants to author mock reports for better understanding of Signal Reports

-Assignment of 3-4 different mock reports

-Doubt clearing sessions

Outline

-What is Signal and why it is important in PV.

-Different Sources of Signal.

-Different Signal Approaches- Qualitative & Quantitative Methods

-In-depth understanding of Signal Detection, Validation, Assessment & Prioritization with different scenarios covering Drug-Event Pair

-What is EVDAS & FAERS methods of Signal Detection

-What is next steps post Signal Assessments

-Causality Assessment & Interpretation

-What is Reference Safety Information (RSI). Covering detailed information on different sections of RSI

-How to analyse Signal Line Listings (LL). How to develop search strategies for Safety topics/Risks. Importance of MedDRA SMQ.

-Empirica Signal Guidance

-Guidance on Signal TemplateParticipants to author mock reports for better understanding of Signal Reports

-Assignment of 3-4 different mock reports

-Doubt clearing sessions

Speaker/s

MrAjay Sharma has around 10+ years of experience in Safety Writing and aggregate reports.

Schedules

Jul 18, 2021 - Sep 19, 2021
Total Hours: 32
No. of Participants: 4
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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.

Pharmamentor
India 401105
7400082233
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