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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EU official says ICH Q6B is outdated and needs revision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...
RoundupsRoundups
FDA Approvals Roundup: Cytalux, Lyvispah, Caldolor
Posted 01 December 2021 By Renee Matthews
A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
ReconRecon
Recon: FDA advisors narrowly back Merck’s COVID drug; Sanofi to buy Origimm for its acne vaccine candidate
Posted 01 December 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
RAPS AnnouncementsRAPS Announcements
RAPS' LatestRAPS' Latest
RAPS releases updated Regulatory Competency Framework
Posted 30 November 2021 By Zachary Brousseau
RAPS today announced the release of its updated Regulatory Competency Framework, describing the essential elements of what is required of regulatory professionals at four key career and professional levels. The framework is relevant to r...
ReconRecon
Recon: FDA panel to weigh in on Merck’s COVID antiviral pill; Aspen signs deal for J&J COVID vaccine
Posted 30 November 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
ReconRecon
Recon: Blueprint's $250M preclinical buy; WHO, CDC, Biden react to Omicron variant
Posted 29 November 2021 By Kari Oakes
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
ReconRecon
Recon: Califf nomination timeline slips after Biden admin misses paperwork deadline; Canada fully approves J&J COVID vaccine
Posted 24 November 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
ReconRecon
Recon: Global license deal to provide COVID antibody test tech free to poorer countries; GSK partners with Arrowhead for NASH drug
Posted 23 November 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Virtual Programs Virtual Programs
Europe Europe
In-Person In-Person
RA Considerations During Clinical Development in the EU
Thursday, 17 February 2022 (9:00 - 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.
In-Person In-Person
Europe Europe
The EU Clinical Trial Regulation
Friday, 18 February 2022 (9:00 - 12:00PM) 6.0 RAC Credits Members: € 550 Nonmembers: € 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.
Books Books
Essentials of Healthcare Product Labeling (Paperback)
Member: $125.00 Nonmember: $175.00
Learn details on labeling for the full lifecycle of human healthcare products, from target labeling through submission and marketing in the US, EU and Canada.
Books Books
Key Regulatory Topics: eCTD (Paperback)
Member: $87.50 Nonmember: $112.50
eCTD guidance documents from the ICH, EMA, and FDA.
Books Books
Global Pediatric Development of Drugs, Biologics, and Medical Devices
Member: $130.00 Nonmember: $180.00
This book takes a comprehensive look at global regulations, guidance, and incentives for the development of products for the pediatric population.
Books Books
International Combination Products (Paperback)
Member: $125.00 Nonmember: $175.00
This book provides an in-depth look at this breakthrough field and covers three major regulatory regions – the US, Canada, and Europe.
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.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Regulation of Biosimilars [2.0 RAC]
2.0 RAC Credits
Member: $255.00 Nonmember: $350.00
This course is for regulatory professionals interested in biosimilar development and regulatory approval strategies.
Books Books
Risk Evaluation and Mitigation Strategies for US Drug Development, Second Edition by Edward Tabor, MD (Paperback)
Member: $37.50 Nonmember: $62.50
A comprehensive analysis FDA’s REMS program, including insight from new guidance documents and recent REMS approvals.
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.
     
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