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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.
Europe Europe
Virtual Programs Virtual Programs
The EU Clinical Trial Regulation
Friday, 18 February 2022 (9:00 - 4:00PM) 6.0 RAC Credits Member: € 550 | Nonmember: € 650
Learn how changes for assessment and approval of multinational clinical trial authorization applications will impact trials conducted inside and outside the EU to avoid delays and minimize the time for approval.
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
Regulatory Applications of Science and Risk-Based Stability Strategies
Tuesday, 26 April 2022 (10:00 - 3:00PM) 6.0 RAC Credits Members: $495 | Nonmembers: $580
This two-day, interactive workshop will provide an overview of the principles and recent biopharmaceutical industry applications of science and risk-based stability approaches used in the last 10 years.
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
Europe Europe
RA Considerations During Clinical Development in the EU
Thursday, 17 February 2022 (8:30 - 4:00PM) 6.0 RAC Credits Members: € 555 | Nonmembers: € 650
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
2021 China NMPA (CFDA) Key Updates and 2022 Forecast
Monday, 28 February 2022 (10:00 - 11:00AM) 1.0 RAC Credits Members: $0 | Nonmembers: $0
This webcast will show how manufacturers can expedite the path to market for new China NMPA submissions. It will cover Order 739, when to file for modifications, how to keep medical devices compliant, and more.
Virtual Programs Virtual Programs
US Regulatory Essentials, Devices
Tuesday, 22 March 2022 (10:00 - 3:30PM) 12.0 RAC Credits Members: $825| Nonmembers: $970
This online workshop offers a comprehensive overview of U.S. regulatory affairs for medical devices and IVDs.
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.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Understanding and Managing the US Clinical Trial Process [4.0 RAC]
4.0 RAC Credits
Member: $465 Nonmember: $640
This course provides an overview of the foundation for clinical trials in the US including their historical evolution, ethical conduct and regulations and the responsibilities of parties involved in clinical research
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Globalization of Clinical Research Trials and Investigations [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course will cover regulatory requirements for conducting pivotal clinical trials in three countries that are often discussed as critical for global registration—China, India and Japan.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Good Clinical Practice (GCP) [2.0 RAC]
2.0 RAC Credits
Member: $255.00 Nonmember: $350.00
This course identifies the regulations on the proper conduct of clinical research with human subjects that were put in place due to ethical issues in human research.
On-demand On-demand
The Shifting Global Regulatory Landscape: Dealing with Regulatory Affairs in an Uncertain Environment
1.0 RAC Credits
Member: $0 Nonmember: $20
This webcast will not try to predict how the geopolitical world will change as a consequence of COVID-19, but will cover current hot topics and emerging challenges affecting regulatory affairs professionals globally.
On-demand On-demand
China NMPA Clinical Evaluation and Trial Key Changes to Support Order 739 Webcast
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will explore the evolving regulations for China NMPA, reviewing regulations related to clinical evaluation, the main changes under Decree #739 in areas of clinical evaluation pathways.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Pharmaceuticals: Definition & Lifecycle [1.0 RAC]
1.0 RAC Credits
Member: $135.00 Nonmember: $185.00
This course also provides an introduction to the lifecycle of drug products, from discovery to on-market support.
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.
On-demand On-demand
SaMD Product Development: Addressing Challenges through Early Integration of Regulatory, Quality and Clinical Data Strategies
Member: $0.00 Nonmember: $20.00
This webcast will focus on best practices and proven strategies to address challenges presented by today’s shifting SaMD regulatory environment, and discuss the keys to commercial success.