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Regulatory NewsRegulatory News
This Week at FDA: Pediatric use for Lilly’s COVID mAbs; Will Woodcock stay on?
Posted 03 December 2021 By Michael Mezher, Kari Oakes
Welcome to month two of our weekly digest of regulatory news from the US Food and Drug Administration (FDA) and other corners of the health care product world. This week saw the expansion of Eli Lilly’s emergency use authorization (EUA) ...
TrackersTrackers
COVID-19 vaccine tracker
Posted 03 December 2021 By Jeff Craven
Updated 03 December with new information on vaccines from Pfizer/BioNTech, Moderna, AstraZeneca, Gamaleya Research Institute, Janssen Vaccines, Sinovac, Bharat Biotech, Shifa Pharmed Industrial Group, and the first authorization of the...
Regulatory NewsRegulatory News
FDA expands eSTAR filing to de novo devices, IVDs
Posted 02 December 2021 By Kari Oakes
US medical device and in vitro diagnostic sponsors who are using the Food and Drug Administration’s de novo pathway will be able to use the eSTAR filing format at the beginning of 2022. A pilot program for the eSTAR template that kic...
Regulatory NewsRegulatory News
FDA announces FY 2022 GDUFA science and research priorities
Posted 02 December 2021 By Joanne S. Eglovitch
The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) has announced its science and research priorities for fiscal year (FY) 2022 to spur the development of complex generic drugs.
RoundupsRoundups
Euro Roundup: EMA chief calls for extra staff to handle growing workload
Posted 02 December 2021 By Nick Paul Taylor
The executive director of the European Medicines Agency (EMA) has told politicians her teams need more support to cope with COVID-19 and their soon-to-be-extended mandate.
ReconRecon
Recon: EMA starts rolling review of Valneva’s COVID vaccine; Biden eyes free at-home tests to curb Omicron
Posted 02 December 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
New reports address generics pricing, innovation in the EU
Posted 01 December 2021 By Kari Oakes
A European generics trade association is calling for relaxation of “extreme cost containment policies” against generic medicines, asserting that such measures are counterproductive and may endanger the supply chain through consolidation ...
Regulatory NewsRegulatory News
EU official says ICH Q6B is outdated and needs revision
Posted 01 December 2021 By Joanne S. Eglovitch
The International Council for Harmonization’s (ICH) Q6B guideline setting acceptance criteria for new biological products needs to be revised to incorporate a more patient-centric approach and to include the science and risk-based concep...
In-Person In-Person
Europe Europe
Software as a Medical Device
Tuesday, 15 February 2022 (9:00 - 5:00PM) 12.0 RAC Credits Members: € 945 Nonmembers: € 1,120
Review current and evolving regulatory requirements for software as a medical device in order to navigate the challenging expectations for software products.
Virtual Programs Virtual Programs
Business Writing for Regulatory Professionals
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* 06:00 (Washington, DC) / 12:00 pm (Brussels) / 18:00 (Hong Kong)
Virtual Programs Virtual Programs
Business Writing for Regulatory Professionals
Friday, 17 June 2022 (6:00 - 7:30AM) 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* 06:00 (Washington, DC) / 12:00 pm (Brussels) / 18:00 (Hong Kong)
Virtual Programs Virtual Programs
Business Writing in Regulatory Settings
Friday, 18 November 2022 (1:00 - 2:30PM) 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* 06:00 (Washington, DC) / 12:00 pm (Brussels) / 18:00 (Hong Kong)
Virtual Programs Virtual Programs
Biologics CMC: Phase Appropriate Product Development
Tuesday, 14 December 2021 (9:00 - 4:00PM) 12.0 RAC Credits Member: $800 Nonmember: $900
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
Talking to Decision Makers: What to Say and How to Say It
Thursday, 13 January 2022 (8:00 - 9:30AM) 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.
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:$150 NonMembers:$175
Learn to analyze improperly written documents and revise them so they will reflect the reader’s true intent and protect yourself and your organizations from unwelcome surprises.
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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Product Bundle Product Bundle
Regulatory Basics Bundle - US & Canada
Member: $400.00 Nonmember: $560.00
This bundle provides fundamental information on product lifecycles, gives insight into professional roles and responsibilities and discusses regulatory mechanisms, processes and agencies within key markets.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Role of the Regulatory Professional [1.0 RAC]
2.0 RAC Credits
Member: $25.00 Nonmember: $25.00
This course discusses the evolution of the regulatory profession, the professional’s roles and responsibilities and normal roles available within a regulatory organization.
Product Bundle Product Bundle
Regulatory Basics Bundle - Complete
Member: $500.00 Nonmember: $700.00
This bundle provides fundamental information on product lifecycles, gives insight into professional roles and responsibilities and discusses regulatory mechanisms, processes and agencies within key markets.
On-demand On-demand
Meet the Authors, Regulatory Intelligence 101, Third Edition
Member: $0.00 Nonmember: $0.00
The three leading authors will answer your questions on why this book needed to be revised and why all regulatory intelligence (RI) professional can benefit from this update.
On-demand On-demand
Managing Global Regulatory Complexity: Five Strategies to Optimize Regulatory Compliance in New Markets
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Join us for a regulatory professional’s presentation on Managing Global Regulatory Complexity: Five Strategies to Optimize Regulatory Compliance in New Markets.
Books Books
Fundamentals of Japanese Regulatory Affairs, Second Edition (Japanese language) (Paperback)
Member: $55.00 Nonmember: $75.00
This Japanese language version covers premarket and postmarket requirements for healthcare products.
Books Books
EU Regulatory Acronyms & Definitions, Sixth Edition (Paperback)
Member : $10.00 Nonmember: $15.00
An EU reference guide with entries in biologics, medicinal products, and medical devices.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Global Regulatory Strategy for Pharmaceuticals [4.0 RAC]
4.0 RAC Credits
Member: $465.00 Nonmember: $640.00
This course provides a basic understanding of the challenges and goals confronting a regulatory professional when defining a global regulatory strategy.