Learn how leading regulatory experts are helping sponsors accelerate global submissions through parallel filing strategies, early agency alignment, and practical execution across multiple regulatory pathways.

Bringing innovative therapies to patients faster requires more than traditional sequential submissions. As global development programs become increasingly complex, sponsors are adopting parallel regulatory strategies to accelerate approvals while maintaining compliance across multiple health authorities.

In this on-demand webinar, MMS regulatory experts share practical insights into planning, coordinating, and executing parallel global submissions. Drawing on real-world experience, the discussion explores how organizations can align regulatory strategy, submission timing, and content development to support faster, more efficient approvals.

Beyond regulatory guidance, this session focuses on the operational realities of parallel submissions—highlighting proven approaches that reduce risk, improve collaboration, and strengthen submission readiness across global programs.

Speaker

Amanda Beaster – Senior Director, Regulatory Strategy, MMS
Sharon Morton – Principal Regulatory Strategist, MMS
Philippe Motté – CEO, Celestial Consulting & Coaching

Moderator

Ben Dudley – Chief Commercial Officer, MMS

Watch This Webinar To:  

  • Understand how parallel submission strategies can accelerate global regulatory approvals.
  • Learn how to build a single, globally aligned dossier that supports multiple regulatory agencies.
  • Discover practical approaches to pre-submission planning, sequencing, and cross-functional coordination.
  • Explore strategies for achieving early alignment with global health authorities.
  • Gain real-world insights into managing parallel submissions across complex development programs.
  • Hear expert perspectives on overcoming common regulatory challenges while reducing submission timelines.

What You Will Learn:

  • Best practices for developing a coordinated global regulatory strategy.
  • How parallel submissions differ from traditional sequential filing approaches.
  • Methods for improving collaboration across regulatory, clinical, and operational teams.
  • Practical techniques for managing timelines, content consistency, and submission readiness.
  • Key considerations for maximizing regulatory efficiency across multiple regions.

Topics We’ll Explore:

  • Parallel versus sequential global submission strategies
  • Global regulatory planning and execution
  • Early agency engagement and scientific advice
  • Submission timing, sequencing, and coordination
  • Building globally consistent regulatory dossiers
  • Lessons learned from real-world regulatory programs

Who Will Benefit From Attending?

This webinar is designed for:

  • Regulatory Affairs Leaders
  • Global Regulatory Strategists
  • Clinical Development Leaders
  • Regulatory Operations Professionals
  • Program and Project Managers
  • Submission Managers
  • Biotech and Pharmaceutical Sponsors
  • Professionals responsible for global regulatory planning and execution

FAQs

Is this webinar available on demand?
Yes. Register to access the webinar anytime.

Who should watch this webinar?
Professionals involved in global regulatory strategy, submission planning, and regulatory operations.

What practical insights will I gain?
You’ll learn proven approaches for coordinating parallel submissions, aligning global regulatory activities, and improving submission efficiency using real-world examples.

Is there a cost to attend?
No. This webinar is available free of charge after registration.

Register Now