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.

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Virtual Programs Virtual Programs

Strategies in Meetings: Achieving Your Objectives

Friday, 21 October 2022 (8:00 - 9:30AM)
1.5RAC 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 (November2022)

Friday, 04 November 2022 (1:00 - 3:00PM)
2.0RAC Credits
Member: $195 | Nonmember: $230
Become a more effective communicator by enhancing your conflict resolution and negotiation skills.
Virtual Programs Virtual Programs

Business Writing for Regulatory Professionals: Making It Easy

Friday, 18 November 2022 (1:00 - 2:30PM)
1.5RAC Credits
Member: $150 | Non-member: $175
Learn to write documents in a clear and well‐organized manner under short deadlines, that are correct, complete and concise.
On-demand On-demand

FDA Forecast: What’s Next for the FDA in 2022? (On-Demand)

1.0RAC Credits
Member: $0 NonMember: $0
In this webcast, AgencyIQ’s regulatory intelligence team will explore the top regulatory issues and challengers they expect the FDA and life sciences industry to encounter next year.
Virtual Programs Virtual Programs

Software as a Medical Device

Tuesday, 25 January 2022 (9:00 - 4:00PM)
12.0RAC Credits
Member: $970 |Nonmember: $1,150
Join regulatory experts to explore evolving global regulatory requirements affecting SaMD, including determining when software is considered regulated as SaMD and how to determine correct class/classification.
Virtual Programs Virtual Programs

Digital Health: Fundamentals of FDA Regulation

Friday, 11 February 2022 (11:00 - 12:30PM)
1.5RAC Credits
Members: $160 | Nonmembers: $175
Examine how FDA regulates digital health including SaMD, AI/ML and cybersecurity, and learn about the implications of the new FDA draft guidance on recommended software documentation for premarket submissions.
Virtual Programs Virtual Programs

Japan 2022: Medical Device Regulatory Update

Wednesday, 16 February 2022 (11:00 - 12:30PM)
1.5RAC Credits
Members: $175 | Nonmembers: $200
Learn the required steps and documentation needed to enter the Japanese medical device market, as well as registration and reimbursement strategies and landmines to avoid.
Virtual Programs Virtual Programs

Navigating Strategies for Postmarket Clinical Follow-up

Tuesday, 15 March 2022 (8:00 - 10:00AM)
2.0RAC Credits
Members: $230 | Nonmembers: $270
This workshop will walk you through a clear process to effectively planning your PMCF activity that fits your product portfolio.
Virtual Programs Virtual Programs

Biologics CMC: Phase Appropriate Product Development

Thursday, 17 March 2022 (9:00 - 4:00PM)
12.0RAC Credits
Member: $825 | Nonmember: $970
Learn how to handle technical issues affecting biologic product development challenges and expectations in the US, Europe, and other highly regulated regions.
Virtual Programs Virtual Programs

US Regulatory Essentials, Devices

Tuesday, 22 March 2022 (10:00 - 3:30PM)
12.0RAC Credits
Members: $825| Nonmembers: $970
This online workshop offers a comprehensive overview of U.S. regulatory affairs for medical devices and IVDs.