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MODULE 2: MAPPING AND GIS!! Had, I\'m Alex. I was told I will be your guide for this module. So here\'s the thing, mapping is a profession that is way old. We are talking at least 8,000 years old.

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Start by identifying the key components of the process or system you want to map out.

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What is module 2 mapping and?

Module 2 mapping is a process of identifying and documenting the relationship between the safety data in a medicinal product's Summary of Product Characteristics (SmPC) and the corresponding safety data in its risk management plan (RMP).

Who is required to file module 2 mapping and?

Marketing Authorization Holders (MAHs) are required to file module 2 mapping.

How to fill out module 2 mapping and?

Module 2 mapping can be filled out by comparing the safety data in the SmPC with the safety data in the RMP and documenting the relationships.

What is the purpose of module 2 mapping and?

The purpose of module 2 mapping is to ensure consistency and alignment between the safety information provided in the SmPC and the RMP.

What information must be reported on module 2 mapping and?

Module 2 mapping requires reporting on the relationship between safety data in the SmPC and the RMP.

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