RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

Virtual Programs Virtual Programs
3rd Party Servicing: Underreported, Understudied, and Underregulated
Wednesday, 18 May 2022 (1:00 - 2:30PM) 1.5 RAC Credits Pricing: $0
Learn the difference between servicing and re-manufacturing a medical device, the regulatory requirements for each, concerns with unregulated 3rd party servicing activities and potential solutions to the problem.
Virtual Programs Virtual Programs
US Regulation of Advertising, Promotion, and Labeling for Medical Devices (2022)
Wednesday, 25 May 2022 (12:00 - 4:00PM) 6.0 RAC Credits Members: $580 NonMembers: $680
This virtual program will examine current guidelines and expectations for medical devices and how they impact the way you communicate with prospective and end users.
Virtual Programs Virtual Programs
Introduction to Regulatory Submissions in the eCTD Format - June 2022
Thursday, 23 June 2022 (10:00 - 5:00PM) 12.0 RAC Credits Members: $970| Nonmembers: $1,150
Join RAPS for a two-day workshop on regulatory submissions in eCTD format, discussing both the underlying CTD structure and their options for implementing operational changes for electronic applications.
Virtual Programs Virtual Programs
Preparing to Take the RAC Devices Exam - Oct 2022
Tuesday, 11 October 2022 (5:00 - 8:30PM) 6.0 RAC Credits Members: $580|Non-members: $680
For those preparing to take the RAC Devices exam. Workshop will focus on critical, analytical & strategic test-taking skills and be facilitated by a panel of regulatory professionals who have earned their RAC.
Virtual Programs Virtual Programs
Strategies in Meetings: Achieving Your Objectives
Friday, 20 May 2022 (1:00 - 2:30PM) 1.5 RAC Credits Member: $150 | Nonmember: $175
Discover ten techniques that will improve your ability to persuade others to pursue a course of action.
Virtual Programs Virtual Programs
Conflict Resolution and Negotiation: Effective Tools and Techniques (June 2022)
Friday, 03 June 2022 (1:00 - 3:00PM) 2.0 RAC Credits Member: $195 | Nonmember: $230
Become a more effective communicator by enhancing your conflict resolution and negotiation skills.
Virtual Programs Virtual Programs
The Digital Transformation of MedTech Regulatory Affairs
Thursday, 16 June 2022 (11:00 - 12:30PM) 1.5 RAC Credits Members: $175| Nonmembers: $200
Learn how organizations can respond to the growing adoption of digital solutions by global regulatory agencies and how to process a higher volume of submissions, while improving data quality and consistency.
Virtual Programs Virtual Programs
Business Writing for Regulatory Professionals: Making It Easy
Friday, 17 June 2022 (1:00 - 2:30PM) 1.5 RAC Credits Members: $175| Nonmembers: $200r> Learn to write documents in a clear and well‐organized manner under short deadlines, that are correct, complete and concise. *Global Time Zones* 06:00 (Washington, DC) / 12:00 pm (Brussels) / 18:00 (Hong Kong)
     
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Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Regulation of Generic Drugs in the US [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course provides a basic understanding of the legal and regulatory structure of generic drugs in the US.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Intermediate Medical Writing: Pharmaceuticals and Biologics [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course will provide an overview of some of the more complex documents prepared by regulatory and medical writers, with a focus on the Common Technical Document (CTD).
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Intermediate Medical Writing: Medical Devices [2.0 RAC]
2.0 RAC Credits
Member: $255.00 Nonmember: $350.00
This course provides an overview of some of the more complex documents prepared by regulatory and medical writers, including key sections of the Premarket Approval and 510(k) Premarket Notification applications
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Medical Devices: Corrections, Removals and Directed Recalls [6.0 RAC]
6.0 RAC Credits
Member: $570.00 Nonmember: $790.00
This course examines compliance with US FDA, Health Canada, and European Union requirements and regulations.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Pharmaceuticals: Compliance & Audits [5.0 RAC]
5.0 RAC Credits
Member: $545.00 Nonmember: $745.00
This course provides knowledge of fundamental, high-quality auditing practices and skills.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
REMS and RMPs [3.0 RAC]
3.0 RAC Credits
Member: $365 Nonmember: $500
This course provides an overview of the history of risk management, reviews risk management philosophies and examines regulatory requirements and interactions between industry and regulators in the US, EU and Canada
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Medical Devices: Risk Management [4.0 RAC]
4.0 RAC Credits
Member: $465.00 Nonmember: $640.00
This course is intended for professionals of all experience levels interested in the techniques of risk management as applied to product safety for medical devices.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Medical Devices: Compliance & Audits [5.0 RAC]
5.0 RAC Credits
Member: $545.00 Nonmember: $745.00
This course is designed for quality and regulatory professionals with little or no previous auditing experience and individuals who need to broaden their knowledge of the audit process.

All Results

Virtual Programs Virtual Programs

3rd Party Servicing: Underreported, Understudied, and Underregulated

Wednesday, 18 May 2022 (1:00 - 2:30PM)
1.5RAC Credits
Pricing: $0
Learn the difference between servicing and re-manufacturing a medical device, the regulatory requirements for each, concerns with unregulated 3rd party servicing activities and potential solutions to the problem.
Virtual Programs Virtual Programs

US Regulation of Advertising, Promotion, and Labeling for Medical Devices (2022)

Wednesday, 25 May 2022 (12:00 - 4:00PM)
6.0RAC Credits
Members: $580 NonMembers: $680
This virtual program will examine current guidelines and expectations for medical devices and how they impact the way you communicate with prospective and end users.
Virtual Programs Virtual Programs

Introduction to Regulatory Submissions in the eCTD Format - June 2022

Thursday, 23 June 2022 (10:00 - 5:00PM)
12.0RAC Credits
Members: $970| Nonmembers: $1,150
Join RAPS for a two-day workshop on regulatory submissions in eCTD format, discussing both the underlying CTD structure and their options for implementing operational changes for electronic applications.
Virtual Programs Virtual Programs

Preparing to Take the RAC Devices Exam - Oct 2022

Tuesday, 11 October 2022 (5:00 - 8:30PM)
6.0RAC Credits
Members: $580|Non-members: $680
For those preparing to take the RAC Devices exam. Workshop will focus on critical, analytical & strategic test-taking skills and be facilitated by a panel of regulatory professionals who have earned their RAC.
RAC Prep RAC Prep

RAC (Devices) Prep Toolbox

Member: $1,250 ​Nonmember: $1,550
The Toolbox brings together a full range of valuable resources, gives you a sense for the kinds of questions you will be tested on and clarifies how the exam is structured.
RAC Prep RAC Prep

RAC (Drugs) Prep Toolbox

Member: $1,250 ​Nonmember: $1,550
The Toolbox brings together a full range of valuable resources, gives you a sense for the kinds of questions you will be tested on and clarifies how the exam is structured.
On-demand On-demand

Chapter Webcast: Best Practices for Management of Companion Diagnostics (CDx) Partnerships (On-Demand)

Member: $0 NonMember: $25
This program will cover the key elements and strategies for effective management of Companion Diagnostics.
On-demand On-demand

Sponsored Webcast: EU IVDR: Intriguing Insights, Recommended Actions, and a Look Towards the Future

1.0RAC Credits
Member: $0 NonMember: $25
Leveraging notified body expertise and real life industry feedback, this webcast is designed to reflect on lessons learned under the IVDR and discuss what the future may look like for diagnostics in Europe.
On-demand On-demand

Meet the Authors: Regulation of Regenerative Medicine: A Global Perspective

1.0RAC Credits
Price: $0
Hear from the authors who wrote RAPS' latest book, Regulation of Regenerative Medicine: A Global Perspective. Regenerative medicine is a growing field with more countries focused on generating governing regulations.
On-demand On-demand

Sponsored Webcast: The Next Generation of Postmarket Medical Device Surveillance

1.0RAC Credits
Member: $0 NonMember: $25
Panelists will discuss postmarket medical device surveillance including the Active Surveillance Task Force, Common Data Model, and the Active Surveillance Cloud Infrastructure from a variety of perspectives.