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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
On Demand Webcast
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Chicago Chapter: EU MDR 2020 – State of Implementation: Are You Confident That You’re on the Right Path?

Join the RAPS Chicago chapter for an EU MDR 2020 webcast by leading MDR expert, Dr. Bassil Akra, vice president of strategic business development at TÜV SÜD.
EU MDR Member Knowledge Center
E-Book
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RF Article Series: Regulatory Intelligence and Policy

This collection provides everything you need to know about regulatory intelligence and policy.
business and leadership
E-Book
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RF Article Series: Regulatory Management and Leadership Strategies

This collection provides everything you need to know about regulatory management and leadership strategies.
business and leadership
E-Book
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RF Article Series: Global Regulatory Strategies and Best Practices

This collection provides everything you need to know about global regulatory strategy.
APL
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
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
On Demand Webcast
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Risk Evaluation and Mitigation Strategies: Modifications and Revisions – Guidance for Industry (On-demand Webcast)

This webcast will provide an overview of the REMS: Modification and Revision Guidance. This was originally recorded on 11 December 2018.
drugs Risk Management
E-Book
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RF Article Series: The Strategic Role of the Regulatory Professional

This edition brings together some of the top regulatory influencers from around the world—all with diverse experience—and offers their perspectives on how the shifting landscape and evolving regulatory approaches are impacting the regulatory profession today.
regulatory strategy
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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Utah Chapter Webcast: Getting Ready for the EU’s IVDR – What You Need to Know to Begin Preparing Today

Get guidance on where your organization should start with implementation preparations for the IVDR. Learn to create a viable transition strategy starting with senior leadership and throughout your entire organization.
IVDR Member Knowledge Center
Webcast
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San Francisco Bay Area Chapter Webcast: Cybersecurity – No Longer an Afterthought

Get a deeper understanding of the evolving Cybersecurity requirements for Medical Devices. Cybersecurity experts will provide the latest information coming from the FDA and other regulators.
medical devices Member Knowledge Center privacy cybersecurity
Webcast
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Twin Cities Webcast: Navigating the New IVDR Rule-Based Risk Classification for Your IVD Products

Prepare now for the new IVDR rule-based risk classification before they go in effect May 2022. This webinar will teach how the IVDR classification changes will impact your IVD products and how to begin preparing for IVDR.
IVDR IVD Products Member Knowledge Center Risk Classification
Webcast
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RAPS European Council (REC) Webcast: Peer Insights on the Real Impacts of MDR Postponement and Remote Audits on our European Regulatory Community

Join us for four brief presentations from European peers with insights and perspectives about how to prepare and optimize your organization for MDR postponement and remote audits in the COVID-19 landscape.
EU MDR Member Knowledge Center Audits
On Demand Webcast
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Utah Chapter Webcast: Legal aspects of FDA regulatory Compliance: Preparing for an FDA Facility Inspection and Responding to a 483 Letter

Learn elements to a successful inspection strategy for adequate preparation and implementing an inspection plan before FDA knocks on your door.
inspection Member Knowledge Center 483 fda
Webcast
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Chicago Chapter Webcast: IVDR Notified Body Update

Enjoy a two-hour engagement with a Notified Body on IVDR State of Implementation.
Notified Body IVDR Member Knowledge Center
Webcast
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New York/New Jersey Chapter Webcast: Raising the Regulatory Voice

Hear from an expert with more than 35 years of experience in helping regulatory professionals communicate clearly, concisely, and persuasively.
negotiation Member Knowledge Center communication presentation skills
Webcast
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Wisconsin Chapter Webcast: Embracing the Growth – An Update on MedTech in Asia

Learn about the region’s growth, hear about its regulatory issues, get business development insights, and hear about how the medical device market can advance through innovation and strategic effectiveness in Asia’s markets.
china asia Member Knowledge Center medtech medical device japan
Webcast
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New York/New Jersey Chapter Webcast: OTCMonograph Reform Amongst the COVID Economic Recovery Package

With the passage of the CARES Act on 27 March 2020, the system regulating the majority of drugs on the U.S. market underwent significant reform. Learn about key elements of the new law and how current and future OTC products may be affected.
OTC Monograph Member Knowledge Center