Upcoming Webinar | September 24 | 15:00-16:00 PM CEST

Webinar: Future Of Regulatory Affairs

Man in medical equipment testing a drug sample in a laboratory.

Regulatory requirements for data, submissions, and manufacturing oversight are changing in measurable ways. Health authorities and pharmaceutical companies are increasingly relying on structured data, interoperability, and AI to support regulatory operations and decision-making.

In response to these expectations, organizations are revisiting how product and manufacturing data are governed, how submissions are assembled, and how regulatory teams work across functions. As a result, the scope of Regulatory Affairs is expanding beyond submissions to include data governance, cross-functional coordination, and operational enablement.

To examine how these changes are being addressed in practice, we invite you to join our webinar, “The Future of Regulatory Affairs.” This session will explore the regulatory and technology trends influencing how regulatory operations are designed and executed today.

Who is speaking at the webinar?

Laurent Lefebvre, Head of Regulatory Affairs Data & Technology, Novartis
Rowan Nidd, Head of Regulatory Affairs, NNIT
Caitrin O’Shea, Vice President R&D, NNIT

What to Expect

This webinar will address likely regulatory and technology developments expected to affect Regulatory Affairs over the coming years. Topics will include data governance models, interoperability approaches, and current uses of AI in regulatory contexts.

Agenda

The changing regulatory landscape
Overview of current and emerging regulatory trends, including how health authority initiatives such as FDA’s PQ/CMC program, EMA’s ePI and IDMP requirements, evolving ICH standards and AI are driving the shift to structured data and changing how product data are managed, submissions are prepared, and teams collaborate.
Rowan Nidd, Head of Regulatory Affairs, NNIT
Enabling the future of Regulatory Affairs
An exploration of how FHIR-based data exchange and new interoperability models are connecting manufacturing data with regulatory submissions, creating structured data to support enterprise-wide efficiency and AI goals.
Caitrin O’Shea, Vice President R&D, NNIT
Getting ready for ICH M4Q(R2) and M16 Structured Product Quality Submissions
A practical industry perspective of how the new dossier structure of M4Q(R2) is supporting the coming digitalization of the CMC dossier content by ICH M16 SPQS. By embracing these emerging standards early and embedding them into manufacturing, technical development and regulatory processes, companies can expect better reliability of data and greater cross-functional efficiency.
Laurent Lefebvre, Head of Regulatory Affairs Data & Technology, Novartis

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