Artificial intelligence (AI) is increasingly shaping regulatory affairs, and this transformation goes far beyond generative AI. This webinar will provide an overview of the different AI approaches being used today in regulatory affairs and what they mean for day-to-day work. This includes pre and post approval document authoring, regulatory intelligence, artwork and labelling, submissions and responses to authority questions. We will discuss key considerations before any AI solution is introduced to regulatory departments including data and governance to help participants reflect on the capabilities and practices that support safe and effective adoption. We will also look at the translational skills required to enable rgulatory professionals to design workflows where humans and AI work effectively together to anticipate issues early.

Registration Fees & Deadlines

Learning Objectives

• Gain awareness of the breadth of AI approaches beyond generative AI for regulatory affairs.
• Understand what to consider upfront including data and governance considerations in your regulatory department.
• Explore what translational regulatory skills can support effective human AI collaboration.
• Appreciate why human judgement is critical for quality, compliance and strategic decisions.

Who Should Attend?

Regulatory Professionals and scientific professionals who interact with Regulatory Affairs in their day to day roles.

Audience Learning Level

Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.

Speakers

Nicholas Littlebury
EVP Regulatory Affairs, Coronado Research

Nick is a senior regulatory leader for life sciences with 19 years’ experience in the industry. He has spent the last 13 years managing teams and client projects in global regulatory consulting environments across medicines and devices. Prior to this he worked for both niche and global pharmaceutical companies in regulatory affairs as well as the UK government regulator (MHRA). He has acted as the regulatory lead for health authority GvP inspections and is a qualified ISO 9001 internal auditor. He has a strong focus on regulatory strategy and innovation including integrated regulatory affairs and artificial intelligence technology solutions.

Jennifer Bradford
VP Data Science, Coronado Research

Jennifer has a diverse background spanning academia, contract research organisations and pharmaceutical companies. She has a proven track record in leading the development and implementation of customer-centric digital solutions, including artificial intelligence and data science, within industry. With over 20 years of experience at the intersection of digital innovation and clinical research in both the pharmaceutical industry and academia, she has been instrumental in leveraging advanced digital technologies to deliver value to organisations. Her career began in proteomics research and has since evolved to include clinical drug development and pharmaceutical applications, where she has consistently bridged the gap between scientific knowledge and the practical implementation of technical solutions.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions