Virtual Programs Virtual Programs
REC Webinar: Due Diligence
Friday, 09 September 2022 (4:00 - 5:15PM) 1.0 RAC Credits Learn how to approach Due Diligence with respect to acquisitions of products and intellectual property, requiring critical RA & QA/QMS competencies from both a buyers' and sellers' perspective, thereby guiding the process from both sides.
Virtual Programs Virtual Programs
Preparing to Take the RAC Devices Exam
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
Conflict Resolution and Negotiation: Effective Tools and Techniques (November2022)
Friday, 04 November 2022 (1:00 - 3:00PM) 2.0 RAC Credits Member: $230| Nonmember: $270 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) 1.5 RAC Credits Member: $175| Non-member: $200
Learn to write documents in a clear and well‐organized manner under short deadlines, that are correct, complete and concise.
Virtual Programs Virtual Programs
Sponsored Webcast: Advantages of Engaging Ahead: How Partnership & Collaboration Enable eCTD Submission Publishing Success
Wednesday, 24 August 2022 (11:00 - 12:00PM) 1.0 RAC Credits Member: $0 | NonMember: $0
Certara will demonstrate how how regulatory operations specialist were able to partner with Advaxis, Inc. to optimize regulatory operations processes.
Virtual Programs Virtual Programs
Biologics CMC: Phase Appropriate Product Development
Wednesday, 28 September 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $970 | NonMember: $1150
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
Preparing to Take the RAC Drugs Exam
Tuesday, 04 October 2022 (11:00 - 4:00PM) 12.0 RAC Credits Members: $970 NonMembers: $1,150
Designed specifically for those preparing to take the RAC Drugs exam. This workshop will be facilitated by a panel of RAC-certified regulatory professionals and focuses on sharpening strategic test-taking skills.
Virtual Programs Virtual Programs
China NMPA Medical Device Regulations & NEW Revisions and Guidance
Monday, 07 November 2022 (8:00 - 12:00PM) 12.0 RAC Credits Member: $825 NonMember: $970
This interactive, three-day program will explore the fundamentals of Chinese NMPA regulations for medical devices, emphasizing updated revisions and guidance released within the last two years.
     
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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
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective

Pharmaceuticals: Compliance & Audits [5.0 RAC]

5.0RAC 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]

3.0RAC 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]

4.0RAC 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]

5.0RAC 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.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective

Pharmacovigilance [4.0 RAC]

4.0RAC Credits
Member: $465.00 Nonmember: $640.00
This introductory course provides an overview of pharmacovigilance across a spectrum of topics, presenting both US and global perspectives.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective

Quality System Regulation (QSR) [5.0 RAC]

5.0RAC Credits
Member: $545.00 Nonmember: $745.00
This course is organized to align with the organization of the subparts and paragraphs as presented in the QSR.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective

Pharmaceuticals: Canadian Regulations [6.0 RAC]

6.0RAC Credits
Member: $570.00 Nonmember: $790.00
This course will introduce you to essential areas of regulatory knowledge for a broad range of pharmaceutical, radiopharmaceutical and biologic products in Canada.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective

Pharmaceuticals: EU Regulations [6.0 RAC]

6.0RAC Credits
Member: $570.00 Nonmember: $790.00
This course provides an overview of the regulations and legislative framework, as well as the EMA entities responsible for medicinal product reviews.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective

Pharmaceuticals: US Regulations [5.0 RAC]

5.0RAC Credits
Member: $545.00 Nonmember: $745.00
This course covers the requirements to obtain prescription and over-the-counter drug approvals and other requirements that are in place to ensure compliance with FDA regulations.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective

Regulation of US & EU Biologics [5.0 RAC]

4.0RAC Credits
Member: $545.00 Nonmember: $745.00
This course examines the special characteristics of biologic products and the challenges associated with their development in the US and EU.