Live Workshop Title here
The Future of Regulatory CMC Submissions
Regulatory CMC is moving from documents to data. Learn what ICH M4Q(R2), ICH M16, FDA PQ/CMC and FDA KASA mean for how quality information is authored, submitted and assessed.
- Free 60-minute live session
- Led by Neha Parashar, RAC, PMP
- Latest ICH and FDA initiatives
- Practical, day-to-day examples
- Live Q&A with the speaker
From documents to data.
Regulatory CMC submissions are changing. New ICH guidelines and FDA programmes are moving quality information from static documents towards structured, reusable data.
Neha Parashar explains what is changing, why it matters and what it means for the people who author, publish and maintain CMC dossiers. Expect clear explanations, practical examples and time for your questions.
Five topics. One hour.
- Topic 01
ICH M4Q(R2)
What changes in Module 2 and Module 3, and how the revised quality structure affects the way you plan and write CMC content.
- Topic 02
ICH M16 and FDA PQ/CMC
Structured quality submissions explained: what structured product quality data looks like and why regulators are asking for it.
- Topic 03
FDA KASA
How quality assessment is evolving with the Knowledge-aided Assessment and Structured Application approach.
- Topic 04
Digital regulatory and AI
The impact on authoring and lifecycle management, and what to prepare for in your own team and systems.
- Topic 05
Practical examples
What this means for our day-to-day work, illustrated with real-world CMC situations. Bring your questions.
Built for the people who shape the quality dossier.
Regulatory Affairs
Plan submissions with the new structure and expectations in mind.
CMC
See how development and manufacturing data will flow into structured submissions.
Quality
Understand how assessment is changing and what reviewers will look for.
Regulatory Operations
Prepare publishing and lifecycle processes for data-centric submissions.
Digital Regulatory
Connect structured data, automation and AI to real regulatory use cases.
Neha Parashar
RAC, PMP | Founder and CEO, RegAtrium
Neha has more than 13 years of experience in global regulatory affairs, with deep expertise in CMC strategy for biologics and combination products. Her career spans Biocon, Merck and argenx.
After nearly a decade in Germany, she concluded her corporate journey as Director, CMC Regulatory and Devices at argenx, where she led global regulatory strategy, submissions and health-authority interactions across major markets.
- 13+years in regulatory affairs
- 8years in Germany
- RAC, PMPcertified
Reserve your free place.
Register to receive your joining link for the live session.
Questions? Write to info@regatrium.com or WhatsApp +91 96851 00662.
- Sunday, 25 October 2026
- 11:00 AM to 12:00 PM IST
- Live online, with Q&A
Global Regulatory CMC Strategy for Biologics
A three-day live online workshop, 20 to 22 November 2026, from development strategy and global registration to Digital CMC.
About Lesson
Almost before we knew it, we had left the ground. All their equipment and instruments are alive.Mist enveloped the ship three hours out from port. The spectacle before us was indeed sublime.A red flair silhouetted the jagged edge of a wing.