This webcast will help regulatory teams sequence Labeling, ePI, eCTD v4.0, and structured CMC requirements by building one governed, reusable structured 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.
Mesa redonda com a participação de líderes da área de Assuntos Regulatórios de medicamentos e produtos para saúde para discussão de como a liderança pode se preparar para os desafios futuros.
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
This webcast will demonstrate the unique benefits of applying human factors methods and solutions to clinical and IDE trials. You will learn specific human factors techniques for risk analyses, training, instructions, interaction videos, and checklists.
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.
Stay ahead of rapidly changing global cybersecurity requirements for medical devices. This two-day interactive workshop will provide regulatory, quality, and technical professionals with the tools and knowledge needed to address cybersecurity risks, strengthen regulatory submissions, and meet expectations from health authorities worldwide that you can apply immediately.
In our last session on XaaS and AI, we presented an approach for implementing cloud and AI technologies in regulated environments. The natural next question is: where does an organization begin? For regulatory affairs professionals, the answer comes back to one thing: how well your regulatory information is structured and managed. In this session, we will explore a system built with this exact objective in mind: the Regulatory Information Management (RIM) system.
Participating in RAPS France LNG in person social event is the perfect opportunity to expand your network and share your insights on topics most relevant to health products. Interested CE marking process? You will also have the opportunity to speak to GMED team who kindly sponsored this event.
With dedicated programme streams for human medicines (pharmaceuticals), medical devices, IVDs and veterinary medicines, the Symposium is the must-attend event in the regulatory affairs calendar.
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.
Join RAPS Twin Cities for an interactive keynote on what separates regulatory leaders who truly move the enterprise, with Jackie Peterson, PCC, CEO of Lift Bridge Leadership. Leave with one committed action.
Join RAPS Philadelphia for an in-person panel on pediatric rare disease drug development. Explore evolving regulatory strategies, innovative evidence generation, patient engagement, and practical approaches to advancing therapies for children.
Join us for a networking and recruitment series across multiple in-person events. Meet regulatory professionals, connect with chapter leaders, and learn about ambassador and leadership roles.
This 4-hour virtual workshop compares FDA, EU, MDSAP, NMPA, MFDS, and PMDA expectations, inspection trends, documentation requirements, and responses to findings, using case studies to strengthen global inspection readiness and compliance.
