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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
Preparing to Take the RAC Devices Exam
Tuesday, 15 March 2022 (5:00 - 8:30PM) 6.0 RAC Credits Members: $495 |Non-members: $580
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
Root Cause Investigation for CAPA
Tuesday, 05 April 2022 (11:00 - 3:00PM) 12.0 RAC Credits Member: $825 | Nonmember: $970
Investigative tools used to identify technical root causes, systemic root causes, corrective and preventive actions, as well as control plans to monitor and prevent recurrence.
Virtual Programs Virtual Programs
Preparing to Take the RAC Drugs Exam
Tuesday, 08 February 2022 (11:00 - 4:00PM) 12.0 RAC Credits Members: $970 |Non-members: $1,150
Designed specifically for those preparing to take the RAC Drugs exam, workshop will be facilitated by a panel of RAC-certified regulatory professionals and focuses on sharpening strategic test-taking skills.
Virtual Programs Virtual Programs
Japan 2022: Medical Device Regulatory Update
Wednesday, 16 February 2022 (11:00 - 12:30PM) 1.5 RAC 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) 2.0 RAC 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) 12.0 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, 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.
Books Books
Complete GHTF Guidance Document Bundle
Member: $62.50 Nonmember: $82.50
A GHTF bundle of 24 guidances for medical devices: 10 from Study Group 1, eight from Study Group 2, three from Study group 3, two from Study Group 4 and one from Study Group 5.
On-demand On-demand
Achieving Medical Device Development Success Through Early Implementation of Regulatory, Reimbursement and Clinical Research Strategies
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn best practices and proven strategies to address challenges presented by today’s shifting regulatory environment and the keys to commercial success.
Books Books
Risk Management Principles for Devices and Pharmaceuticals
Member: $130.00 Nonmember: $180.00
Expanded and updated risk management information on healthcare products around the world.
Books Books
Fundamentals of Canadian Pharmaceutical, Biologic and Medical Devices Regulations
Member: $100.00 Nonmember: $150.00
A compilation of Fundamentals of Canadian Pharmaceutical and Biologics Regulations and Fundamentals of Canadian Medical Device Regulations.
Books Books
Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition
Member: $160.00 Nonmember: $225.00
This book presents a systematic approach to creating a global strategy to meet the requirements of multiple regulatory systems.
On-demand On-demand
China NMPA (CFDA) Regulatory Approval: Clinical Evaluation and Pathways
6.0 RAC Credits
Member: $480.00 Nonmember: $540.00
This workshop will cover different clinical evaluation and pathways and how to decide which pathway to choose to support China NMPA medical device/IVD regulatory approval or postmarket study requirements.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Good Laboratory Practice (GLP) [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course provides an overview of GLP regulations as they are applied and interpreted by the FDA, EPA and the Organization for Economic Cooperation and Development.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Medical Devices: EU Regulations [5.0 RAC]
5.0 RAC Credits
Member: $545.00 Nonmember: $745
This course provides a solid understanding of medical device regulation in the EU. It covers the history of medical device regulation in Europe and follows the regulatory requirements throughout the product life.