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Products

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E-Book
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RF Article Series: Risk Management Principles: A Global Perspective

Inside you will find a collection of insightful articles covering the latest risk management principles.
Quality Compliance and Risk
E-Book
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RF Article Series: Global Reimbursement Strategies

This is a one of a kind RAPS product; written and reviewed by volunteer subject matter experts in the regulatory profession. It’s a holistic approach to reimbursement in one convenient format.
regulatory strategy medical device
E-Book
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RF Article Series: Transitioning to the New EU MDR and EU IVDR

In the second Regulatory Focus (RF) article series, leading global regulatory experts share their valuable insights and practical experience on how to comply with the new EU MDR and EU IVDR.
eu medical device
E-Book
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RF Article Series: Orphan Drug Regulations: A Global Perspective

This is a one of a kind RAPS product; written and reviewed by volunteer subject matter experts in the regulatory profession.
pharmaceuticals
E-Book
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RF Article Series: Global Advertising, Promotion and Labeling Regulations: What you Need to Know

Inside you will find a collection of insightful articles covering global Advertising, Promotion and Labeling (APL) regulations.
APL
Webcast
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Advancing and Enabling Regulatory Science to Impact Policy at CDRH: The AIMBE FDA Scholars Program (On-demand Webcast)

The American Institute for Medical and Biological Engineering (AIMBE) Scholars will share what was required to gain this prestigious role and how relationships with the FDA staff have affected their futures in the medical device industry positively.
biologics and biotechnology
Online Course
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New EU Medical Device and IVD Regulations

RAPS Executive Director, Paul Brooks explains some of the changes in the new EU MDR/ IVDR.
eu medical device
Webcast
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Sizzle & Spice - Creating Stellar Presentations (On-demand Webcast)

Learn how to design and deliver your program with a participant-centered focus to achieve true audience transformations. Recording of webcast from 2 August 2018.
business and leadership
E-Book
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RAPS 2018 Compensation and Scope of Practice Report

The compensation data provide individual regulatory professionals, employers, recruiters and other stakeholders insight into the market value of regulatory work and expertise, and allow comparison of differences in compensation based on variables such as job level, experience and education.
business and leadership
RAC Prep
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RAC Interactive Presentation

Learn more about the new RAC exams.
rac prep
Online Course
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Regulatory Competency Framework and Guide

The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
business and leadership
E-Book
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Choosing the Right Regulatory Career

Learn about the regulatory role in small and large companies and the differences for regulatory professionals working for device and pharmaceutical firms.
business and leadership
Webcast
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Designing Your Career as a Regulatory Professional (On-demand Webcast)

You know professional development is important, but it's not that easy to come up with plans that make a difference in performance.
business and leadership
Webcast
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How to Better Manage Quality and Risk with a Global Change Control Strategy (On-demand Webcast)

Learn about the contributing factors to building change control system that can help manage risk as well as metrics to consider to drive success.
Quality Compliance and Risk
Webcast
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21 CFR 820 Quality System Regulation and ISO 13485 Medical Devices (On-demand Webcast)

The RAPS Philadelphia Chapter webcast covering 21 CFR 820 quality system regulation and ISO 13485 medical devices.
Quality Compliance and Risk medical device
Webcast
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Overview of China's Regulatory System & New Medical Device Regulations (On-demand Webcast)

What is the new regulatory system in China? What are the new regulations? What are the major changes? What are the key challenges for the industry? The webcast introduces the overall new regulatory system and outlines the regulatory framework in China.
asia medical device
Webcast
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Getting Ad-Promo on Board the eCTD Train (On-demand Webcast)

With the release of a new draft guidance in April 2015, FDA now is enabling companies to submit their ad-promo submissions using eCTD. Learn more about this process and hear from the latest updates from FDA.
pharmaceuticals
Webcast
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Giving Voice to Regulatory Leadership (On-demand Webcast)

Learn the professional development skills you need for success, including how to advance these critical skills and how to improve the power of your regulatory voices strategically.
business and leadership
Webcast
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The Unconscious Conversation (On-demand Webcast)

This webcast is based on new communications research showing when we communicate there actually are two conversations occurring at the same time—one conscious, the other unconscious.
business and leadership
Webcast
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Strategies for Your Career: Finding YOUR Pathway into Regulatory Affairs (On-demand Webcast)

Ideas and techniques are provided for improving how effectively you network and advocate for yourself within this highly competitive discipline. These concepts can give you an edge when you are considering your next career move and provide perspective for developing a long-term career strategy.
business and leadership
Webcast
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The Supervision of Medical Device Label and Instruction for Use in China (On-demand Webcast)

Learn more about the medical device lifecycle in China.
asia medical device
Webcast
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We Need to Talk (On-demand Webcast)

This webcast explores internal communication know-how and persuasion strategies to improve cooperation and effectiveness at work.
business and leadership
Webcast
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A Roadmap for Driving Messages through Development, Submission and Beyond (On-demand Webcast)

Learn to build persuasive arguments that help smooth project management and regulatory strategy during development, submission and beyond.
business and leadership regulatory strategy
Webcast
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Understanding and Applying FDA’s 510(k) Modifications Guidance (On-demand Webcast)

FDA’s guidance on when to submit a 510(k) for a changed device is significant and wide-ranging in its impact. This webcast will review key aspects of the guidance, provide historical and other perspectives on its use, and present ideas on how to effectively implement it.
medical device