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Regulatory NewsRegulatory News
RAPS' LatestRAPS' Latest
Orphan drug experts discuss new book on developing rare disease treatments
Posted 27 January 2022 By Zachary Brousseau
The authors of RAPS’ Orphan Drug Development for Rare Diseases discuss the importance of orphan drugs, the peculiarities and challenges of obtaining an orphan drug designation (ODD), and what is covered in the book.
Regulatory NewsRegulatory News
Stakeholders split over FDA’s contentious proposed rule for OTC hearing aids
Posted 27 January 2022 By Jeff Craven
The US Food and Drug Administration (FDA) has received a number of comments over the past few months on its proposed rule that would create a new regulatory category for over-the-counter (OTC) hearing aids for adults with mild or moderat...
ReconRecon
Recon: Pfizer gets conditional OK from EMA for Paxlovid; Moderna starts trial for Omicron booster shot
Posted 27 January 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Feature ArticlesFeature Articles
Maximizing the potential of the FDA assessment aid: Genentech’s experience
The assessment aid (AAid), an initiative of the US Food and Drug Administration’s (FDA’s) Oncology Center of Excellence (OCE), was introduced in 2018 as a pilot program to help streamline the agency’s review of oncology drug applications...
Regulatory NewsRegulatory News
EU foresees reenergized clinical trial sector as new regulations take effect
Posted 27 January 2022 By Nick Paul Taylor
The Clinical Trials Regulation will enable sponsors to apply to run clinical trials in 30 European countries at the same time using the same documentation.
Regulatory NewsRegulatory News
Aurobindo warned for lax investigations, repeat GMP violations
Posted 26 January 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) hit Indian drugmaker Aurobindo with a warning letter for inadequately investigating batch failures related to its manufacturing of active pharmaceutical ingredients (APIs) and for failing to eval...
RoundupsRoundups
FDA Approvals Roundup: Kimmtrak, Skyrizi, Veklury
Posted 26 January 2022 By Renee Matthews
Our update on new drug approvals and indications from the US Food and Drug Administration (FDA) focuses this week on Kimmtrak, Skyrizi, and Veklury.
Virtual Programs Virtual Programs
Learn the Ins & Outs of China NMPA E-Filing
Wednesday, 23 March 2022 (10:00 - 1:00PM) 6.0 RAC Credits Members: $495|Nonmembers: $580
China NMPA Order 739 introduced a series of changes in NMPA medical device registration requirements. This workshop will provide an overview of updated requirements for electronic medical device and IVD submissions
Europe Europe
Virtual Programs Virtual Programs
Rollout IVDR 2022: How to prepare for the IVDR by May 2022. Date of Application or Dead on Arrival?
Wednesday, 23 March 2022 (1:00 - 5:00PM) 12.0 RAC Credits Member: € 710 | Nonmember: € 835
Learn which aspects to consider when writing a regulatory plan, along with several pathways to speed up development, including PRIME and adaptive pathways.
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
Biologics CMC: Phase Appropriate Product Development
Thursday, 17 March 2022 (9:00 - 4:00PM) 12.0 RAC 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
Biologics CMC: Regulatory Challenges and Trends
Thursday, 19 May 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $825|Nonmember: $970
Overview of chemistry, manufacturing and control (CMC) regulatory requirements and best practices associated with biologic and biosimilar products. Emphasis on requirements in US, Europe, and other regulated regions.
Virtual Programs Virtual Programs
Biologics CMC: Phase Appropriate Product Development
Thursday, 21 July 2022 (9:00 - 4:00PM) 12.0 RAC 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
Biologics CMC: Phase Appropriate Product Development
Thursday, 08 December 2022 (9:00 - 4:00PM) 12.0 RAC 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, 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
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Project Management for Regulatory Professionals [4.0 RAC]
4.0 RAC Credits
Member: $465 Nonmember: $640
This course provides guidance for effectively establishing a regulatory development project plan, including identifying resources and determining the effort and timing required to create project and budget reports.
On-demand On-demand
Efficiency and Technology Pave the Way for the New Age of Narrative Writing
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
You will also learn how to add efficiency in your narrative process through the use of streamlined safety data reporting and implementation of technology.
On-demand On-demand
A Roadmap for Driving Messages through Development, Submission and Beyond
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
Participants will learn to build persuasive arguments that help smooth project management and regulatory strategy during development, submission and beyond.
On-demand On-demand
Stay on Track and Get Some Sleep: Marketing Application Best Practices
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Regulatory experts will offer tips and guidance for acceleration, submission leadership, and regulatory strategy from that you can apply to your marketing application to help ensure a successful submission.
On-demand On-demand
How to Integrate Risk Management Throughout the Lifecycle of a Medical Device in the Coming Decade
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will review the application of a modern approach to risk management as a product moves through the product lifecycle.
On-demand On-demand
Plan to Accelerate Your Time to Drug Submissions
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
We'll discuss each stage of the submission, variations such as size of the development program, type of submission, and dealing with governance bodies.
On-demand On-demand
Achieving 21 CFR 11 Compliance with Cloud-Deployed Systems
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
We'll describe the challenges faced by small FDA-regulated companies in managing and controlling the content of eTMF, eCTD and QMS.
On-demand On-demand
Driving Innovation: Planning for CTD Submissions with Language Excellence
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Language service providers can help pharmaceutical companies navigate CTD submissions required by recent regulatory changes in APAC countries such as China.

All Results

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

Project Management for Regulatory Professionals [4.0 RAC]

4.0RAC Credits
Member: $465 Nonmember: $640
This course provides guidance for effectively establishing a regulatory development project plan, including identifying resources and determining the effort and timing required to create project and budget reports.