Upcoming Events

This intensive 16-hour course, delivered across 4 half days, will give you an excellent grounding in the EU requirements for clinical evaluation.

Explore the evolving regulatory landscape for CGT combination products focusing on device development and potency assay requirements.

AI-enabled medical devices must meet overlapping FDA, EU MDR, and EU AI Act requirements. Learn to operationalize compliance with shared data and AI to reduce manual work and accelerate audit-ready submissions.

This webcast will demystify the Human Factors Use-Related Risk Analysis (URRA), explain why it is often misused, and share a proven approach to build and apply URRA distinct from other risk management tools.

This hands‑on workshop demystifies IVDR and CTR requirements, empowering regulatory professionals to confidently navigate today’s evolving precision‑medicine landscape to better clarify biomarker-driven drug development.

Explore the unseen risks at the intersection of Medical Information and Pharmacovigilance.

Learn how governed AI and Agile workflows help regulatory teams scale plain language summaries for CTIS, reduce manual rework, and support clearer, more consistent outputs—featuring a live AgileWriter.ai® demo.

Overview of chemistry, manufacturing and control (CMC) regulatory requirements and best practices associated with biologics. Emphasis on requirements in US, Europe, and other regions.

Manage EU MDR & 510(k) simultaneously without duplicating effort. Best-practice frameworks and practical guidance.

Learn how PRRCs are functioning at organizations small and large, internal or outsourced, manufacturer or authorized representative, and working with medical devices or IVDs.

Whether you are new to medical devices or looking to strengthen your expertise, this intensive 16-hour course, delivered across four half days, has everything you need to confidently implement ISO 14971.

A focused exploration of ISO 10993-1:2025 revision that equips teams to align documentation and manage rising from 2018 revision when remain globally compliant with FDA guidance.

In this workshop, you will learn to align regulatory writing and operations for faster, high-quality global submissions. Discover how early collaboration, shared standards, and smart planning reduce rework, risks, and delays.

This workshop is designed to help regulatory and product development teams successfully bring AI/ML-enabled medical devices to market. You will learn global reg. perspectives from the US FDA, EU MDR and China NMPA.

Learn practical applications and implementation strategies for AI tools in your everyday regulatory affairs and compliance needs

QA/RA teams are under pressure to use AI, but validating non-deterministic tools is unclear. This session provides a risk-based framework to define scope, generate audit-ready evidence, and maintain compliance w/o delay.

The submission process for Master Notified Body Opinions concerning drug-device combinations as required by EU MDR 2017/745.

This workshop will address the gaps, if any, in the current ISO 13485: 2016 QMS standard to avert cybersecurity threats and ensure data integrity.

Is the zero-experience RAPS FRA credential right for you? It's the ideal way for early-career or transitioning professionals to prove foundational RA knowledge to employers and to jump-start their careers.

Join this free webcast to find out whether RAC credential is right for you and how to get started. Discover how earning this globally recognized certification can boost your earning potential and your regulatory career.

This intensive 16-hour course, delivered across 4 half days, will give you an excellent grounding in the EU requirements for clinical evaluation.

This interactive course gives clinical affairs, regulatory and quality professionals a focused overview of EU IVDR 2017/746 performance study requirements for IVDs and companion diagnostics, with an emphasis on pharma/biotech teams moving into diagnostics or partnering with IVD manufacturers. You’ll explore performance study design and conduct, QMS alignment with ISO13485 and IVDR, bridging analytical to clinical performance, vendor and diagnostic endpoint selection, and dual EU regulatory pathways, and leave with a practical framework for performance study plans to work with CROs or diagnostic sponsors that satisfy both notified bodies.

Gain confidence in implementing the EU MDR! Receive useful advice on updating your quality system, overseeing economic operators, addressing labeling, and handling technical documentation.