Module 12: Data Management and Digitalisation in Regulatory Affairs - 7FHH1150

Data Management and Digitalisation in Regulatory Affairs

Next course: 1 December 2021

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Gives an understanding of the theoretical background to data management, document management, electronic submissions, eCompliance, regulatory information management and the new Identification of Medicinal Products (IDMP) requirements. It will help students find solutions to practical problems in this area; and deal with large volumes of data and different data – from nonclinical to post-market pharmacovigilance.

Overview

Data management has always been a key part of regulatory affairs from nonclinical data to post-market pharmacovigilance – and the amount of data and the complexity of the data analysis are increasing.

This module covers data management in daily regulatory affairs work, including digitisation, EMA telematics strategy, EMA collaboration strategy, archiving of documents, CSV, regulatory information management, regulatory intelligence and knowledge management, and big data approaches to RA.

Although some parts were new and require deeper understanding, the presenters were very open and easy to communicate with to gain knowledge. In addition, experiences shared by others on the course helped show how others tackle issues in a different way."

Learning outcomes

Knowledge and understanding

Successful students will typically:

• Be able to explain the importance of data, document and information management and critically evaluate the IDMP requirements
• Demonstrate a critical understanding of the processes and requirements necessary for completing an eCTD (electronic common technical document)
• Demonstrate a conceptual understanding of data and document management in daily regulatory affairs work and identify issues with electronic compliance.

Skills and attributes

Successful students will typically:

• Be able to make recommendations about regulatory information management and IDMP strategies
• Manage documents and data in an effective and efficient way
• Critically analyse data and documentation strategies and processes
• Critically appraise regulatory processes and documentation
• Be able to explain the basis for electronic regulatory submissions.

Focusing on global regulatory affairs? Consider:

• Module 4: Regulatory Strategy for a New Active Substance: Global Clinical Development
• Module 5: Regulatory Control of Clinical Operations
• Module 6: Regulatory Strategy: From Development to the Market Place
• Module 8: Data for Abridged Applications and Specialised Products

Expanding your options? Consider:

• Module 1: Strategic Planning in Regulatory Affairs
• Module 20: Regulation of Electrical, Electronic and Software Devices

See the table below for the next planned dates for these modules.

Module schedule

The following table outlines the scheduling for all MSc modules through 2025.

Visit our Masterclasses page to see which modules are currently open for registration.