Data Generation for Regulatory Agencies: A Collaborative Approach

A common dataset from diverse stakeholders can help make regulatory decision-making easier and more cost-effective. Task forces and submitted data can be used by regulators to evaluate individual products.

Format: Hardback
Length: 188 pages
Publication date: 12 July 2022
Publisher: Oxford University Press Inc

The process of generating data for regulatory decision-making, particularly for risk assessment purposes, has become increasingly complex and costly. This complexity arises from the fact that data are often generated by different submitters, using diverse protocols and methodologies. As a result, regulatory decision-making becomes challenging as it becomes difficult to reconcile and integrate these diverse data sources.

One potential solution to address these challenges is for the regulated community to collaborate in generating a common dataset. By pooling their resources and expertise, the community can develop a comprehensive and standardized dataset that can be used by regulators to evaluate individual products.

This work aims to highlight the formation, operation, and data submission of task forces, as well as the use of the submitted data by regulators evaluating individual products. It is intended to be a valuable resource for scientists and regulators who are responsible for assessing risks.

The formation of task forces involves bringing together diverse stakeholders together to work towards individual products. These stakeholders may include scientists, regulators, industry representatives, and other interested parties. The task force is responsible for developing a common dataset that meets the specific needs of the regulated community.

Once the task force is formed, it operates by establishing clear guidelines and protocols for data submission. These guidelines may include specific formatting requirements, data quality standards, and security measures to ensure the confidentiality and integrity of the data.

Data submission is typically done through a secure online platform, which allows for easy access and retrieval of the data by regulators. The submitted data may include a wide range of information, such as experimental results, clinical trials, and other relevant data sources.

Regulators then use the submitted data to evaluate individual products. This evaluation may involve assessing the safety and efficacy of the product, as well as its potential risks and benefits. The data submitted by task forces can provide valuable insights into the safety and effectiveness of individual products, which can help regulators make informed decisions about their approval and regulation.

In conclusion, generating a common dataset from diverse stakeholders is a promising approach to addressing the challenges of data generation for regulatory decision-making. By collaborating and pooling their resources, the regulated community can develop a comprehensive and standardized dataset that can be used by regulators to evaluate individual products. This work highlights the formation, operation, and data submission of task forces, as well as the use of the submitted data by regulators evaluating individual products. It is intended to be a valuable resource for scientists and regulators who are responsible for assessing risks.

Weight: 574g
Dimension: 181 x 259 x 18 (mm)
ISBN-13: 9780841298293