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Products

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E-Book
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RAPS 2018 Compensation SOP 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.
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.
Webcast
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On-demand Webcast: Sizzle & Spice - Creating Stellar Presentations

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
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.
IVDR MDR medical device European Regulations
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.
medical devices reimbursement Health Technology Assessment Product Development Medical Technology
On Demand Webcast
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On Demand: RAPS Member Business Meeting

RAPS leaders will review organizational strategic priorities and provide updates on RAPS news and activities in 2017 and to date in 2018.
business development business management
On Demand Webcast
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On-demand Webcast: Advancing and Enabling Regulatory Science to Impact Policy at CDRH: The AIMBE FDA Scholars Program

An on-demand recording of the RAPS Webcast, Advancing and Enabling Regulatory Science to Impact Policy at CDRH: The AIMBE FDA Scholars Program, originally recorded on 29 November 2016.
medical devices biologics and biotechnology
Online University
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New EU Medical Device and IVD Regulations

Paul Brooks explains some of the changes in the new EU MDR/ IVDR
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.
E-Book
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e-Book: 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.
biologics and biotechnology career development pharmaceuticals medical device
Webcast
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Webcast: Designing Your Career as a Regulatory Professional

You know professional development is important, but it's not that easy to come up with plans that make a difference in performance.
Online Course
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Acronyms & Definitions

This page is a valuable reference tool for those new to regulatory as well as experienced professionals. It is also a handy guide for those preparing for any of the RAC exams.
Member Knowledge Center
On Demand Webcast
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On-demand Webcast: China's Clinical Requirements Under the New Registration System

This webcast will introduce the requirements and the process on record filing of clinical trials of medical devices and its related government authorities.
medical devices submission and registration clinical regulatory strategy preclinical
On Demand Webcast
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On-demand Webcast: China Regulations on Medical Devices - Adverse Event Monitoring and Re-evaluation

Under the new regulation, CFDA will perform a more strict post-market surveillance than before. This webcast will provide you with new regulatory requirements and help you establish internal procedures.
medical devices submission and registration postmarket surveillance
On Demand Webcast
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On-demand Webcast: CFDA Registration Requirement for Imported Class II/III Medical Devices

This webcast will help foreign establishment get prepared through the learning of the overall China regulation framework for imported medical devices and provide a detailed introduction of CFDA registration process, requirement and potential cost.
medical devices submission and registration
On Demand Webcast
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On-demand Webcast: The Supervision of Medical Device Label and Instruction for Use in China

On-demand Webcast: The Supervision of Medical Device Labeling and Inspection
medical devices labeling
On Demand Webcast
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On-demand Webcast: Overview of China's Regulatory System & New Medical Device Regulations

An on-demand recording of the RAPS Webcast, Overview of China Regulatory System and New Medical Device Regulations.
medical devices submission and registration postmarket surveillance regulatory strategy
On Demand Webcast
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On-demand Webcast: We Need to Talk

This webcast explores internal communication know-how and persuasion strategies to improve cooperation and effectiveness at work.
business skills business and leadership