The Learning Portal will be under maintenance Monday, 6 December between 6 AM and 5 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

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 ...
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...
RoundupsRoundups
Asia-Pacific Roundup: TGA defies medtech industry by retaining definition of central circulatory system
Posted 30 November 2021 By Nick Paul Taylor
Australia’s Therapeutic Goods Administration (TGA) is keeping its definition of the central circulatory system (CCS) despite universal support for change among medtech respondents to a consultation.
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.
Regulatory NewsRegulatory News
ICH recaps progress made over past year, charts new topics
Posted 29 November 2021 By Joanne S. Eglovitch
The International Council for Harmonisation (ICH) announced that “significant milestones” were reached over the past year, including the adoption of the widely anticipated guideline on general considerations for clinical studies and the ...
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.
Virtual Programs Virtual Programs
Meet the Authors: Global Pediatric Development of Drugs, Biologics, and Medical Devices
Monday, 06 December 2021 (10:00 - 11:00AM) 0.0 RAC Credits Member: $0 NonMember: $0
Four authors from the latest RAPS book, Global Pediatric Development of Drugs, Biologics, and Medical Devices, will be on hand to answer all your burning questions on global pediatric development in regulatory affairs.
Product Bundle Product Bundle
Regulatory Medical Writing Bundle [Package #1]
Member: $1,050.00 Nonmember: $1,440.00
Learn more about the components of various application types and techniques for improving document quality.
Product Bundle Product Bundle
Regulatory Medical Writing Bundle [Complete Package]
Member: $1,240.00 Nonmember: $1,710.00
Learn more about the components of various application types and techniques for improving document quality.
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
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Pharmaceuticals: Canadian Regulations [6.0 RAC]
6.0 RAC Credits
Member: $570.00 Nonmember: $790.00
This course will introduce you to essential areas of regulatory knowledge for a broad range of pharmaceutical, radiopharmaceutical and biologic products in Canada.
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.
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
Giving Voice to Regulatory Leadership
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn the professional development skills you need for success.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Intermediate Medical Writing: Pharmaceuticals and Biologics [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course will provide an overview of some of the more complex documents prepared by regulatory and medical writers, with a focus on the Common Technical Document (CTD).
     
  •  
  • 1
  •  
  • 2
  •  
  • 3
  •  
  • 4
  •  
  •