Developing a successful global regulatory strategy increasingly requires sponsors to think beyond sequential submissions. As sponsors look to bring therapies to patients more quickly across multiple regions, and use of global pathways increases, many sponsors are exploring parallel or closely coordinated filings across multiple agencies.
In this webinar, MMS’ regulatory strategists will discuss the practical realities of planning and executing parallel global submissions, drawing on real‑world experience across various advice procedures.
It is critical to look beyond what the regulations and processes say, and to understand how they really work in practice, including the operational hints and tips to enable successful outcomes. With this in mind, the session will focus on pragmatic, time tested solutions for aligning strategy, timing, and content, to support faster, more coherent submissions when running programs on compressed timelines.
Meet the Speakers
Amanda Beaster
Senior Director of Regulatory Strategy, MMS
Sharon Morton
Principal Regulatory Strategist, MMS
Philippe Motté
CEO, Celestial Consulting & Coaching
Moderator
Ben Dudley
Chief Commercial Officer, MMS
Key Highlights
- Understand how to build a single, coherent dossier that meets global regulatory expectations
- Explore practical approaches to early alignment across global agencies
- Learn how to approach global expediting strategies, including pre‑submission planning, timing, and sequencing
- Gain insight into the operational realities of running parallel submissions
- Hear real‑world lessons from parallel advice and collaborative regulatory review
Inspire. Connect. Innovate.
