Designed for senior regulatory leaders, this program sharpens high-level communication, strategic decision-making, and risk management skills. It equips participants with proven techniques to align stakeholders, foster inclusion, and navigate complex, high-stakes environments with clarity and confidence.
Overview of chemistry, manufacturing and control (CMC) regulatory requirements and best practices associated with biologics. Emphasis on requirements in US, Europe, and other regions.
Gain confidence in implementing the EU MDR! Receive useful advice on updating your quality system, overseeing economic operators, addressing labeling, and handling technical documentation.
RAPS Houston LNG presents the FDA ASCA Program Roadshow Panel Event, featuring Biotex, Inc at the TMC Innovation Factory. This panel brings together an FDA representative and Wade Munsch of Biotex, Inc — the only Houston-based lab currently accredited under the Accreditation Scheme for Conformity Assessment (ASCA) — to explore how ASCA can streamline premarket submissions and improve regulatory efficiency. Ideal for regulatory professionals, quality engineers, lab managers, and life science innovators across the region.
Join the NJ RAPS Chapter as we host a virtual session on how agencies have responded to Humanized Mouse (huMouse) justifications in practice, and how to position these models across development stages. The goal is to help attendees make better-informed decisions about when huMouse models strengthen a regulatory submission — and when they don't.
The ABHI UK HealthTech Conference returns in 2026, bringing together leaders from industry, government, the NHS, and regulation for two days of essential updates, market intelligence, and networking.
This expert-led workshop will show you how to turn regulatory alerts into actionable intelligence using trusted sources, practical prioritization, and clear internal communication.
SGS is excited to bring to the GTA a comprehensive full-day symposium focused on the medical device industry. In partnership with the RAPS Ontario Chapter, the leading association for regulatory professionals, we will focus on navigating the latest quality and regulatory challenges in the Medtech industry, including AI in Medical Device, the latest developments in MDR, a guide to MDSAP and more. Join us for this exciting conference.
Explore FDA standards, ASCA, QMSR, ISO 13485, MDSAP, quality systems, manufacturing controls, and inspection readiness across medical devices, drugs, and biologics. Hear from FDA & industry experts
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.
This webcast will show you how to turn regulatory intelligence into coordinated local action through risk-based impact assessment, stronger global-local governance and practical implementation across markets.
Navigating biological evaluation requirements can be complex and resource-intensive without a clear, forward-looking strategy grounded in current regulations. This session will provide an in-depth overview of the latest updates to ISO 10993-1:2025 and upcoming technical specifications designed to help manufacturers and assessors effectively implement these new expectations. Attendees will gain insight into how global regulatory authorities are recognizing and aligning with these changes, as well as the risk assessment and management principles driving key revisions. Finally, the session will outline strategic planning practices that can be applied early in the product development process to streamline biological evaluation activities, minimize delays, and ensure full compliance with ISO 10993-1:2025.
Explore the dynamics at FDA and why neither “naive harmony” nor inevitable conflict are good approaches to interactions with FDA. Learn effective techniques for strategic preparation and communication to work with FDA to avoid escalation and when needed how to escalate matters within FDA.
An inside look at technical standardization: from contributing to UNI/PdR 140:2023 to applying standards in everyday professional practice. Learn how experts can help shape the standards that support their work
This two-day interactive workshop is designed to equip regulatory and quality professionals with the essential knowledge to guide their organizations in navigating global Software as a Medical Device expectation.
This is the kickoff meeting for RAPS Japan LNG. We will introduce RAPS Japan LNG, which was launched in September, and RAPS's activities, and discuss together the future vision and activities of RAPS Japan LNG.
Assessment of abuse liability is a critical yet often misunderstood component of drug development for products with potential central nervous system activity. Drawing on over two decades of experience collaborating with FDA's Controlled Substance Staff (CSS) through the Cross Company Abuse Liability Council (CCALC), this session will provide insights into the nonclinical and clinical considerations that support a robust abuse liability assessment strategy. Attendees will gain a clearer understanding of regulatory expectations, common challenges, and key sponsor responsibilities that can impact submission success.
Purpose of the Target Product Profile (TPP) and Target Product Label (TPL) Overview of Competitive Labeling Strategy for Clinical Development and Marketing Optimal Timeline for Development of TPP and TPL How the TPL Shapes the Phase 3 protocol Use of Labeling Intelligence in the TPL process
