Is there life outside of signal Detection?
Who does Dona love more than Signal
Little brother
What begins with generalization and moves toward specific predictions
Deductive reasoning
Who are the 6 key receivers of new signal information
TAH, Safety Board, RA, LOC, BP, and Empirica Topics
What is created for non-validated and validated signals
Empirica Topic
What is the platform for the MSR (Monthly Signal Report)
COGNOS IBM
Who has their own personal live Teddy bear
Sue
What interferes with deductive reasoning
Prior knowledge
Who should the GSL/PVS communicate alerts to in a timely-manner
HA and DSO/LOCs
Must be completed for every evaluated signal
Signal Evaluation Form (Form-0003984)
What is a gun or the Global Labeling Oversight Committee
GLOC
Medicinal Chemistry & Pharmacognosy
What is the basis of deductive reasoning
Strength of the evidence
Who the GSL/PVS notify if an update to the Warnings and Precautions section is anticipated (i.e., whenever there is a potential for CCDS/CCSI/RSI update)
Head of GPSE and the Safety Board Chair
Who attaches all relevant documents to the relevant Empirica Topic and updates the topic status and outcome as per the signal evaluation outcome.
PVS
What is the numerical result above a preset threshold generated from any data mining algorithm using disproportionality analysis applied to a spontaneous report database.
Statistic of Disproportionate Reporting (SDR)
What was Dona's specialty area when she practiced as a nurse
Neuro clinical specialist
What is an example of a deductive reasoning step in signal mgt
Causality
Who validated signals meeting the definition of an Emerging Safety Issue (ESI) as per Global Pharmacovigilance Practices (GVP) Module IX – Signal Management, must be communicated to for further assessment
Head of GPSE (PV), the SMT, and the European Union Qualified Person Responsible for Pharmacovigilance (EU-QPPV) (if applicable)
What is appropriate documentation in Topics for a labelling update
Justification documents and/or Global Labeling Oversight Committee (GLOC) Meeting Minutes in addition to FORM-0003984
A safety issue considered by a marketing authorization holder to require urgent attention by the competent authority because of the potential major impact on the risk-benefit balance of the medicinal product and/or on the patients’ or public health, and the potential need for prompt regulatory action and communication to patients and healthcare professionals.
Emerging safety issue (ESI)
Who are we missing today from our Signal Management and Innovation team
Christine
What starts with specific observations and build generalizations
Inductive reasoning
What is the "source" for signal management
Tool-0001894
What is the official signal tracker for Takeda
Empirica Topics
What provides guidance for individual healthcare professionals/providers of the need for certain actions or adapting of their practices in relation to a medicinal product
Direct Healthcare Professional Communication (DHPC)