Virtual Programs Virtual Programs
Cybersecurity Unauthorized
Tuesday, 08 March 2022 (10:00 - 5:00PM) 12.0 RAC Credits Members: $970 | Nonmembers: $1,150
This workshop will help regulatory and quality professionals develop the knowledge they need to help steer their organizations in the right direction when it comes to global cybersecurity expectations.
Virtual Programs Virtual Programs
Introduction to Regulatory Submissions in the eCTD Format - March 2022
Wednesday, 30 March 2022 (10:00 - 5:00PM) 12.0 RAC Credits Members: $825 | Nonmembers: $970
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
US Regulatory Essentials, Pharmaceuticals
Monday, 28 February 2022 (9:00 - 5:30PM) 6.0 RAC Credits Member: $495 |Nonmember: $580
An overview of laws, regulations and guidance affecting US regulation of biologics and pharmaceutical products, this workshop is for new -intermediate level professionals and those preparing for the RAC Drugs exam
Virtual Programs Virtual Programs
Dangerous Documents: Avoiding Land Mines in Your Records and Emails
Thursday, 27 January 2022 (8:00 - 9:30AM) 1.5 RAC Credits Members: $175 | Nonmembers: $200
Learn to analyze and revise written documents to protect yourself and your organization from unwelcome surprises. *Global Time Zones* 08:00 (Washington, DC) / 14:00 (Brussels) / 21:00 (Hong Kong)
Virtual Programs Virtual Programs
Strategies in Meetings: Achieving Your Objectives
Thursday, 10 February 2022 (8:00 - 9:30AM) 1.5 RAC Credits Members: $150 | Non-members: $175
Discover ten techniques that will improve your ability to persuade others to pursue a course of action. *Global Time Zones* 08:00 (Washington, DC) / 14:00 (Brussels) / 21:00 (Hong Kong)
Virtual Programs Virtual Programs
Conflict Resolution and Negotiation: Effective Tools and Techniques (February 2022)
Wednesday, 23 February 2022 (8:00 - 10:00AM) 2.0 RAC Credits Member: $230| Nonmember: $270
Become a more effective communicator by enhancing your conflict resolution and negotiation skills.
*Global Time Zones* 08:00 (Washington, DC) / 14:00 (Brussels) / 21:00 (Hong Kong)
Virtual Programs Virtual Programs
Business Writing for Regulatory Professionals: Making It Easy
Thursday, 10 March 2022 (8:00 - 9:30AM) 1.5 RAC Credits Member: $150 | Nonmember: $175
Learn to write documents in a clear and well‐organized manner under short deadlines, that are correct, complete and concise. *Global Time Zones* 08:00 (Washington, DC) / 14:00 (Brussels) / 21:00 (Hong Kong)
Virtual Programs Virtual Programs
Talking to Decision Makers: What to Say and How to Say It (April 2022)
Friday, 22 April 2022 (1:00 - 3:00PM) 2.0 RAC Credits Member: $195 | Nonmember: $230
Position yourself for success by learning how to succinctly communicate with executives. This event will teach you how to explain issues clearly and how to make yourself an invaluable asset to senior leadership.
     
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Online Course Online Course
Single Certificate Single Certificate
Regulatory Affairs Certificate Upgrade: Medical Devices
Member: $1230 Nonmember: $1540
If you have already successfully completed a Regulatory Affairs Certificate in Pharmaceuticals, you can complete the two remaining core courses of the Dual Certificate and three additional electives.
Online Course Online Course
Single Certificate Single Certificate
Regulatory Affairs Certificate Upgrade: Pharmaceuticals
Member: $1230.00 Nonmember: $1540
If you have already successfully completed a Regulatory Affairs Certificate in Medical Devices, you can complete the two remaining core courses of the Dual Certificate and three addition electives.
Online Course Online Course
Single Certificate Single Certificate
Regulatory Affairs Certificate: Pharmaceuticals
Member: $2360.00 Nonmember: $2950.00
The Regulatory Affairs Certificate: Pharmaceuticals is achieved by completing four core and five elective courses.
Online Course Online Course
Single Certificate Single Certificate
Regulatory Affairs Certificate: Medical Devices
Member: $2360.00 Nonmember: $2950.00
The Regulatory Affairs Certificate: Medical Devices is achieved by completing four core and five elective courses.
Online Course Online Course
Dual Certificate Dual Certificate
Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals (Dual)
Member: $3,590.00 Nonmember: $4,490.00
The Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals is achieved by completing six core and eight elective courses.
Product Bundle Product Bundle
Clinical Trial Foundations Bundle
Member: $575.00 Nonmember: $790.00
Improve your knowledge surrounding the proper conduct of clinical research with human subjects.
Product Bundle Product Bundle
GxP Bundle
Member: $865.00 Nonmember: $1,292.00
This three-course series examines essential topics within a quality system—Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP).
Product Bundle Product Bundle
Regulatory Medical Writing Bundle [Complete Package]
Member: $1,240.00 Nonmember: $1,710.00
Learn more about the components of various application types and techniques for improving document quality.

All Results

Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective

Role of the Regulatory Professional [1.0 RAC]

2.0RAC Credits
Member: $25.00 Nonmember: $25.00
This course discusses the evolution of the regulatory profession, the professional’s roles and responsibilities and normal roles available within a regulatory organization.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective

Good Manufacturing Practice (GMP) [4.0 RAC]

4.0RAC Credits
Member: $465.00 Nonmember: $640.00
This course provides a basic understanding of current Good Manufacturing Practice (CGMP) regulations and their impact on product quality and patient safety.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective

Pharmaceuticals: Advertising and Promotional Labeling in the US [4.0 RAC]

4.0RAC Credits
Member: $365.00 Nonmember: $500.00
This course outlines the regulatory framework for prescription drug and biologic promotional materials by examining FDA regulations and issues involved in producing compliant promotional materials.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective

Medical Devices: Advertising and Promotion in the US [3.0 RAC]

3.0RAC Credits
Member: $365.00 Nonmember: $500.00
This course provides information regarding the primary US agencies regulating medical devices and covers their enforcement tools as well as company strategies for avoiding enforcement actions.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective

Regulation of Biosimilars [2.0 RAC]

2.0RAC Credits
Member: $255.00 Nonmember: $350.00
This course is for regulatory professionals interested in biosimilar development and regulatory approval strategies.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective

Medical Devices: China, Japan, Singapore and South Korea Regulatory Overview [4.0 RAC]

4.0RAC Credits
Member: $465.00 Nonmember: $640.00
This course examines and introduces medical device regulations and registration requirements in China, South Korea, Japan and Singapore.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective

Regulation of Generic Drugs in the US [3.0 RAC]

3.0RAC 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]

3.0RAC 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]

2.0RAC 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]

6.0RAC Credits
Member: $570.00 Nonmember: $790.00
This course examines compliance with US FDA, Health Canada, and European Union requirements and regulations.