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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.
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.
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.
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.
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.
Updates to Annex VII of the EU MDR 2017/745 reshape notified body requirements and their impact on manufacturers. This webcast reviews the changes, their rationale, and implications for organizational structures, competencies, certification activities, and timelines, providing practical insights to support MDR compliance and certification readiness.
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.
This expert-led workshop will show you how to turn regulatory alerts into actionable intelligence using trusted sources, practical prioritization, and clear internal communication.
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 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 interactive four-hour workshop will teach you how PRRCs function at organizations small and large, internal or outsourced, manufacturer or authorized representative, and working with medical devices or IVDs.
This two-hour interactive workshop explores how AI helps regulatory teams spot emerging trends earlier, track policy shifts faster and turn regulatory intelligence into strategic action.
This three-day introductory workshop provides a practical foundation for understanding the regulatory landscape governing combination products in the US, European Union, and key global markets.
Learn how the successful development of combination products will require great collaboration within the industry to overcome regulatory, clinical, and technical challenges.
