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This is a RAPS-SF Executives event exclusive for VP and above. This facilitated roundtable provides an intimate, interactive environment for senior professionals to unpack monumental changes at the FDA, share strategic playbooks, and candidly discuss what the "new normal" at the FDA means for our industry.
Preparing a successful 510(k) requires more than completing a template—it requires a clear regulatory strategy, thoughtful planning, cross-functional coordination, and a thorough understanding of FDA expectations. Join regulatory consultant Nancy Sauer for a practical discussion of 510(k) submission best practices, common pitfalls, and lessons learned from working with FDA's eSTAR submission platform.
Join the NJ and Philadelphia chapters as we host FDA and Intertek speakers discussing FDA’s Accreditation Scheme for Conformity Assessment (ASCA) and how it streamlines premarket review by elevating the quality and consistency of testing laboratories, enabling reviewers to assess complex areas like biocompatibility and EMC in minutes rather than hours. This session explains how ASCA reduces deficiencies, protects test data integrity, and demonstrates through real case studies how submissions once stalled for months can move forward in weeks.
This RAPS education webinar is designed to support students and early-career professionals seeking to better understand career opportunities within regulatory affairs and adjacent fields.
Join RAPS Ontario for our Summer Social, featuring an exciting Speed Networking session and inspiring career conversations. Connect with fellow Regulatory Affairs professionals, students, and industry leaders. Hear diverse career stories, expand your network, and enjoy light snacks and refreshments in a relaxed and welcoming environment.
This webinar explores how Quality Management Systems (QMS) evolve across the organizational lifecycle - from lean startup environments to complex global enterprises. Attendees will gain practical insights on balancing speed and compliance, designing scalable processes, while navigating resources as well as regulatory and cultural challenges at different growth stages. Learn how to navigate QMS that supports innovation while ensuring Global Regulatory Readiness in varying company environments.
A practical session on biological evaluation of medical devices: ISO 10993, US FDA & EU MDR expectations, and chemical characterization. Hosted by TUV SUD with Medtronic.
Join RAPS Southern California, IPM, and Intertek for Connected Health at a Crossroads: Devices, Data, and Convergence, an evening of networking and thought-provoking discussion with MedTech leaders
Now in its 10th edition, the Summit brings together manufacturers, Authorised Representatives, Notified Bodies, regulators, legal experts, policy stakeholders, and industry leaders to discuss the practical realities of MDR and IVDR implementation.
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.
In this webcast, you will learn how to secure your role as an EU compliance professional. Discover the essential steps to earning the RAPS Regulatory Compliance Certification.
This webcast will help regulatory teams sequence ePI, eCTD v4.0, and structure CMC requirements by building one governed, reusable content foundation across global submission timelines.
This webinar will walk you through how to apply the FDA's CSA's risk-based principles to AI, and what that looks like in practice, using a validated requirement conflict detection AI agent as a real-world example.
A practical, two-day workshop that decodes the full ADC development journey — from CMC and analytical control through non-clinical, clinical and expedited pathways to global submissions and market access — using recently approved antibody-drug conjugates as working case studies.
Join a powerful community of healthcare leaders, innovators, and policymakers driving change across the continent. Whether you’re attending, speaking, or sponsoring, AfriSummit is your platform to connect, contribute, and lead.
The MedTech Forum Asia 2026 convenes senior leaders from across industry, government, and healthcare systems to tackle the defining challenge of our time: how to transform MedTech innovation into meaningful, real-world impact for patients at scale.
This webinar will make the case for a global, holistic framework that captures overlapping and interdependent obligations through a coordinated strategy. Learn why managing trial disclosure by country creates gaps, duplication, and missed obligations and why a global "fishing net" strategy captures overlapping requirements more effectively than a single line.
This virtual 2-day workshop will focus on the technical challenges and regulatory expectations faced by biopharmaceutical development scientists and regulatory professionals during the product development lifecycle.
In de afgelopen maanden zijn er diverse voorstellen gedaan vanuit de Europese Commissie voor aanpassingen in wet en regelgeving die impact (gaan) hebben op alle stakeholders die met medische hulpmiddelen en in-vitro diagnostica te maken hebben. Tijdens onze 43e sessie gaan we een dag wijden aan een selectie van de onderwerpen. Hierbij komen vertegenwoordigers van de overheden en Notified Bodies aan het woord, en wordt de impact voor fabrikanten en ziekenhuizen bekeken. Daartoe zijn panels en parallel sessies gepland.
RAQA Leadership Retreat 2026 Join the RAPS Switzerland Chapter RAQA Leadership Retreat 2026 in the Swiss Alps for two days of expert-led discussions, peer exchange, and practical insights designed for today's RA/QA professionals. 2000CHF, 1800CHF for early birds until end of July 2026
