M4Q(R2): The Road to Pragmatic, Modernized CMC Submissions
Overview
Where
Online Webinar
When
December 4, 2025 | 10:00 AM ET
Overview
As 2026 approaches, Notified Bodies are raising the bar for Clinical Evaluation Reports (CERs). The focus is shifting from procedural compliance to scientific rigor – demanding clear endpoint definitions, justified acceptance criteria, and traceable evidence across the entire clinical evaluation process.
In this upcoming webinar, our experts will provide strategic insights on how to prepare CERs that not only meet regulatory requirements but withstand deeper Notified Body scrutiny.
They’ll explore what truly defines an audit-ready CER – from the way endpoints are justified, and data gaps are addressed, to how your claims align with General Safety and Performance Requirements (GSPRs).
Expect real-world perspectives on common deficiencies still flagged by Notified Bodies, including:
- Vague safety/performance objectives
- Poorly defined benchmarks
- Incomplete GSPR mapping
- Unsubstantiated claims.
This is your opportunity to strengthen your 2026 CER strategy with actionable approaches for evidence defensibility, systematic literature rigor, and end-to-end traceability.
Who Should Attend?
This session is designed for professionals involved in regulatory and clinical documentation, including:
- Regulatory Affairs professionals responsible for device submissions and NB communications.
- Clinical Evaluation and Medical Writing specialists developing and maintaining CERs.
- Quality and Compliance managers ensuring MDR readiness.
- Product and Portfolio managers aligning evidence strategies with business goals.
- PMS and Vigilance teams integrating clinical evidence into continuous compliance frameworks.
Why Attend
Join this focused webinar to gain clarity and confidence in preparing CERs that go beyond compliance – ensuring defensibility, consistency, and readiness for 2026 Notified Body expectations.
What You Will Learn
During this session, our experts will cover:
- Defining and justifying endpoints and acceptance criteria that can withstand NB scrutiny, including handling zero-event data and applying confidence intervals transparently
- Designing and validating SLRs that demonstrate quality and reproducibility, not just volume
- Ensuring complete traceability from claims → evidence → risk management → post-market plans
- Using automation and digital tools to streamline CER/SLR workflows for efficiency and audit readiness
- Building a lean but resilient CER roadmap that balances compliance with practicality to minimize NB queries
Webinar Speakers
Senior Manager – Medical Device Services, Celegence
Smridula Hariharan
Smridula Hariharan holds a master's degree in pharmacy and brings over 12 years of medical writing experience spanning regulatory affairs, pharmacovigilance, and clinical research. She has extensive expertise in PMS documentation and has supported CE marking under both MDD and MDR for diverse product categories. Her work focuses on clinical evaluations, PMS and PMCF plans, and audit-ready documentation for successful NB submissions.
Associate Manager – Medical Device Services, Celegence
Dr. Neha Keral
Dr. Neha Keral is an experienced regulatory professional specializing in clinical evaluation and PMS documentation across global markets, including EU MDR, FDA, TGA, MHRA, and Health Canada. With a Ph.D. in Life Sciences focused on antimicrobial and anticancer research, she combines scientific depth with regulatory insight. At Celegence, she leads documentation processes, mentors writing teams, and ensures high-quality, compliant CER and PMS deliverables.
Where
Online Webinar
When
December 4, 2025 | 10:00 AM ET
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