Where regulatory meets e-regulatory: bringing answers to the pharmaceutical industry.

The use of Real World Evidence and AI within the regulatory landscape


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Healthcare data and technology are intertwined, and the regulatory framework governing the medicines regulation is looking to update the regulations to bring them in tune with the use of new technologies and access to new platforms for handling healthcare data in real time.

This whitepaper looks at the roles of AI applications and Real World Evidence in the pharma industry and how both can be leveraged while devising successful global regulatory strategies, including:

- The role of AI in collecting and storage of data - is it being accepted globally?
- AI in pharmacovigilance (handling structured and unstructured datasets)
- Improving safety and risk management
- Real World Evidence and defining its quality
- Initiatives to incorporate RWD into regulatory decision making
- The challenges in using AI in the healthcare industry

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This piece represents the views of the author and not necessarily the views of Informa Connect Life Sciences or the Global Pharmaceutical Regulatory Affairs Summit.

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