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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EU official says ICH Q6B is outdated and needs revision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
International Regulatory Acronyms & Definitions, Third Edition (Paperback)
Member: $10.00 Nonmember: $15.00
International regulatory terms, definitions, and acronyms that will help you develop a better understanding of international regulations.
Books Books
Canadian Regulatory Acronyms & Definitions, Fifth Edition (Paperback)
Member: $10.00 Nonmember: $15.00
For those working in the Canadian market, entries of significance to the Canadian healthcare product industry.
Books Books
Terms & Definitions of Japanese Regulatory Affairs (Paperback)
Member: $32.50 Nonmember: $42.50
English translations of the most important Japanese regulatory terms and acronyms.
Books Books
Fundamentals of Canadian Pharmaceutical, Biologic and Medical Devices Regulations (Hardcover)
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
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.
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
Are You Ready to Begin Planning your IND Submission?
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Regulatory experts will offer advice pertaining to selecting a target indication, seeking pre-IND advice from FDA, deciding whether to use US or non-US sites for early clinical research, and more.
On-demand On-demand
How to Transform Quality and Regulatory Programs from Cost Centers to Profit Centers
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
The webcast features lessons learned from the COVID-19 pandemic about leveraging risk management and quality management systems to maximize business success in times of disruption and digital transformation.
     
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