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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EU official says ICH Q6B is outdated and needs revision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.
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.
On-demand On-demand
EU MDR Prep: Translation Requirements That Will Make or Break Your Devices In Europe
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
The presenters will outline essential information and considerations for device manufacturers across the EU and explain everything you need to do to remain compliant.
On-demand On-demand
How to Facilitate Regulatory Meetings
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will help prepare regulatory professionals for the difficult task of meeting facilitation.
On-demand On-demand
What You Need to Know About FDA Regulation of Medical Product Promotional Labeling
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will discuss considerations for implementing quality systems and procedures that will help you remain in compliance with promotional labeling regulations.
     
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