Events

🎉 RAPS Workshop: EU Medical Device Regulation 2017/745

📅 02nd- 05th September 2025: 08:00-12:00 ET (US & Canada)

🌐 Virtual Event
🎓 12.0 RAC & 12.0 RCC Credits

🔗https://www.raps.org/events/raps-workshop-eu-medical-device-regulation-2017745

🔍 Overview

Gain clarity on the complexities of the EU MDR 2017/745 with practical examples and expert guidance. This workshop is ideal for professionals seeking a foundational understanding of EU medical device regulations.

Topics Include:

Device classification and CE marking
Economic operator and PRRC responsibilities
General Safety and Performance Requirements (GSPRs)
Risk management (ISO 14971)
Technical documentation
PMS, PMCF, and vigilance
UDI and Eudamed

👥 Who Should Attend?

Anyone seeking a basic-level introduction to EU MDR—no prior knowledge required.

🎉 RAPS Workshop: Global Expedited Pathways (US/Global) – Medical Devices

📅 09th- 11th September 2025: 08:30-12:30 ET (US & Canada)

🌐 Virtual Event

🎓 12.0 RAC

🔗https://www.raps.org/events/raps-workshop-global-expedited-pathways-usglobal--medical-devices-september-2025

🔍 Overview

Join this advanced-level workshop to explore how expedited regulatory pathways are helping bring innovative medical devices to global markets faster — especially in times of urgent clinical need. Learn directly from international experts how regulators in the US, EU, Canada, Australia, India, China, Japan, and South Korea are evolving policies to support innovation, patient safety, and public health.

This session also includes insights from industry executives, who will outline how regulatory strategy aligns with market access, pricing, and global commercialization.

Topics covered:

Innovation and green channel pathways
Fast-track approval strategies across major markets
Special review dossiers and risk-based frameworks
Aligning regulatory strategy with VBP, pricing, and reimbursement
Global case studies and real-world examples

👥 Who Should Attend?

Ideal for professionals in:

Clinical & regulatory affairs
R&D, quality, and compliance
Medical affairs and operations
Commercial, finance, and market access roles

Audience Level: Advanced – Designed for those with strong regulatory knowledge; includes interactive case studies and strategy sessions.

🎉 RAPS Webcast: Get Certified in Regulatory Affairs – Get Your RAC Now!

📅 10th September 12:00- 13:00 ET (US & Canada)

🌐 FREE Virtual Event

🔗https://www.raps.org/events/raps-workshop-global-expedited-pathways-usglobal--medical-devices-september-2025

🔍 Overview

Thinking about earning your RAC (Regulatory Affairs Certification)? This informative webcast will help you decide if it’s the right move for your career. Learn how this globally respected credential boosts your credibility, signals your regulatory knowledge, and increases your earning potential — RAC-certified professionals report earning up to 12% more on average.

You'll explore the exam options (RAC-Drugs & RAC-Devices), learn how to prepare, and map out your action plan.

👉 Perfect for those considering the RAC, just starting the process, or looking for tips before the exam.

Topics covered:

What is the RAC and why it matters in regulatory affairs
Overview of RAC-Drugs vs. RAC-Devices exam options
Eligibility requirements and how to apply
Study resources, tips, and preparation timelines
How the RAC credential can enhance your career and salary
Common myths and FAQs about the exam
How to create a personalised RAC preparation plan

👥 Who Should Attend?

RAC-Curious: New to the concept and seeking more info
RAC-Ready: Exploring next steps and preparation plans
RAC Candidates: Already registered and looking for exam tips

Audience Level: Basic – No prior knowledge required.

🎉 RAPS Webcast: Get Your Regulatory Compliance Certification (RCC) Now!

📅 11th September 2025: 12:00- 13:00 ET (US & Canada)

🌐 FREE Virtual Event

🔗https://www.raps.org/events/raps-webcast-get-your-regulatory-compliance-certification-rcc-now-two-new-industry-certifications-from-raps-sept-2025

🔍 Overview

Be among the first to earn the new RCC credential — designed for professionals who want to demonstrate expertise in EU Medical Device (MDR) or In Vitro Diagnostic (IVDR) compliance.

With the creation of the Person Responsible for Regulatory Compliance (PRRC) role under Article 15 of the EU MDR and IVDR, RAPS developed two dedicated certifications: RCC-MDR and RCC-IVDR. This free session will help you decide if the RCC is right for you and show you how to take the first step.

👉 Ideal for professionals aiming to meet PRRC requirements or demonstrate EU compliance expertise.

Topics covered:

What is the RCC? Understanding RCC-MDR and RCC-IVDR
Who the certifications are for and why they matter
PRRC role and its link to EU compliance legislation
Eligibility and how to apply
Study tips, resources, and exam prep
Creating your RCC certification action plan
How RCC credentials support your role and institution

👥 Who Should Attend?

Professionals with at least 1 year of experience working with EU MDR or IVDR who want to:
Qualify for PRRC roles
Strengthen compliance credentials
Lead regulatory efforts within EU-regulated environments
Audience Level: Basic – No prior certification required.

🎉 RAPS Workshop: Championing Diversity in Clinical Trials

📅 16th September 2025: 13:00- 15:00 ET (US & Canada)

🌐 Virtual Event

🎓 2.0 RAC Credits

🔗https://www.raps.org/events/raps-workshop-championing-diversity-in-clinical-trials

🔍 Overview

As the FDA now requires Diversity Action Plans for all Phase 3 and pivotal studies, ensuring equity in clinical trial populations has become a regulatory—and moral—imperative.

This practical and thought-provoking workshop explores why diversity matters in clinical research, what new FDA guidance entails, and how you can develop inclusive, compliant, and rigorous clinical trial strategies.

Led by experienced clinical and regulatory professionals, the session offers actionable strategies for sites, CROs, sponsors, and DEI advocates working to ensure underrepresented populations are included in the clinical research process.

👉 Please click the link above to see the full agenda and speaker lineup.

Topics covered:

Why DEI is essential to rigorous and ethical clinical research
FDA’s 2024 guidance on Diversity Action Plans under FDORA
Comparing global diversity expectations (EMA, MHRA, PMDA)
Responsibilities of sponsors and CROs in advancing trial inclusion
Designing and building a compliant Diversity Action Plan
Institutional risk assessment and regulatory compliance strategies

👥 Who Should Attend?

Regulatory and recruitment specialists
Clinical trial professionals across sites, CROs, and sponsors
Professionals in DEI-focused roles within the clinical research industry
Audience Level: Basic – Suitable for professionals at any stage in their DEI and regulatory journey.

🎉 2025 Medical Writing & Communication Conference

📅 05th- 08th November 2025

🌐 Sheraton Phoenix Downtown, Arizona, USA
340 North 3rd Street, Phoenix, AZ 85004

🔗 https://www.amwa.org/event/2025annualconf

🔍 Overview

The American Medical Writers Association (AMWA) invites you to its flagship annual event — the 2025 Medical Writing & Communication Conference, bringing together professionals across medical writing, regulatory affairs, scientific communication, and related disciplines.

Held in the heart of Phoenix, Arizona, this in-person conference offers a dynamic program filled with practical workshops, expert-led sessions, networking events, and exhibitor showcases.

Whether you're a seasoned writer, aspiring communicator, or team leader, the conference delivers valuable insights, skill-building opportunities, and access to the latest trends in the field.

👉 Click “View Sessions” on the AMWA site to explore the full agenda and session lineup.

🧠 What to Expect

Skill-building workshops tailored to all levels
Industry insights on regulatory writing, publications, med ed, HEOR, and more
Networking with peers, mentors, and thought leaders
Career development and certification opportunities
Poster sessions, roundtables, and expert panels
Exhibitor hall showcasing tools and innovations in med comms

👥 Who Should Attend?

This conference is ideal for professionals and aspiring communicators across the healthcare and life sciences fields, including:
Medical Writers (regulatory, scientific, promotional, or educational)
Medical Editors and Proofreaders
Regulatory Affairs Professionals
Medical Affairs and Publications Managers
Scientific and Health Communicators
Freelancers and Independent Consultants
Researchers and Clinicians transitioning to writing roles
Graduate Students and Postdocs exploring career options in medical communication
Content Strategists and Communication Directors working in health or pharma sectors

Whether you're early in your career or a seasoned expert, this event offers valuable insights, peer connections, and career advancement opportunities

🎉 RAPS Workshop: The Future of Wearable Medical Devices – A Regulatory Perspective

📅 19th September 2025: 09:00- 11:00 ET (US & Canada)

🌐 Virtual Event

🎓 2.0 RAC Credits

🔗 https://www.raps.org/events/raps-workshop-wearable-as-a-medical-device

🔍 Overview

Wearable medical devices are reshaping the future of healthcare, blending cutting-edge innovation with real-time health monitoring. But with innovation comes responsibility — and regulation.

In this interactive session, you'll explore the growing landscape of wearable technology, from fitness trackers to complex clinical-grade devices, and understand how to bring them safely and compliantly to global markets.

You’ll gain insight into the FDA regulatory process, ISO 13485 standards, and global approval pathways, while also exploring device design, usability, cybersecurity, and data privacy — all essential for creating impactful and compliant wearable solutions.

👉 Click the link above for a detailed agenda and speaker bio.

Topics covered:

Types of wearables and their role in healthcare
Regulatory pathways in the US and EU
Design & development best practices
Data security and patient privacy concerns
FDA approval, ISO 13485, and international compliance
Strategies for successful market access and commercialization

👥 Who Should Attend?

Regulatory affairs professionals
Quality managers
Project and product managers in medtech
Anyone involved in wearable device development
Audience Level: Basic – No prior experience required.