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.
Online Course Online Course
Single Certificate Single Certificate
Regulatory Affairs Certificate Upgrade: Medical Devices
Member: $1225 Nonmember: $1580
If you have already successfully completed a Regulatory Affairs Certificate in Pharmaceuticals, you can complete the two remaining core courses of the Dual Certificate and three additional electives.
RAC Prep Bundle RAC Prep Bundle
RAC (Drugs) Reference Package: Complete Bundle
Member: $1,900 Nonmember: $2,600
Referred to as 'Reference Packages', RAC Prep bundles combine several of RAPS individual RAC prep tools together at a discounted rate.
Books Books
Risk Management Principles for Devices and Pharmaceuticals (Hardcover)
Member: $125.00 Nonmember: $175.00
Expanded and updated risk management information on healthcare products around the world.
Online Course Online Course
Dual Certificate Dual Certificate
Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals (Dual)
Member: $3,555.00 Nonmember: $4,445.00
The Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals is achieved by completing six core and eight elective courses.
Books Books
Complete WHO Guidance Documentation Bundle
Member: $15.00 Nonmember: $22.50
A WHO bundle with six guidance documents addressing pharmaceuticals, medical devices, psychotropic substances and plasma.
Online Course Online Course
Single Certificate Single Certificate
Regulatory Affairs Certificate: Pharmaceuticals
Member: $2335.00 Nonmember: $2920.00
The Regulatory Affairs Certificate: Pharmaceuticals is achieved by completing four core and five elective courses.
Online Course Online Course
Single Certificate Single Certificate
Regulatory Affairs Certificate Upgrade: Pharmaceuticals
Member: $1225.00 Nonmember: $1580
If you have already successfully completed a Regulatory Affairs Certificate in Medical Devices, you can complete the two remaining core courses of the Dual Certificate and three addition electives.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Pharmaceuticals: US Regulations [5.0 RAC]
5.0 RAC Credits
Member: $545.00 Nonmember: $745.00
This course covers the requirements to obtain prescription and over-the-counter drug approvals and other requirements that are in place to ensure compliance with FDA regulations.
     
  •  
  • 1
  •  
  • 2
  •  
  • 3
  •  
  • 4
  •  
  •  

All Results

Books Books

Risk Management Principles for Devices and Pharmaceuticals (Hardcover)

Member: $125.00 Nonmember: $175.00
Expanded and updated risk management information on healthcare products around the world.
Online Course Online Course
Dual Certificate Dual Certificate

Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals (Dual)

Member: $3,555.00 Nonmember: $4,445.00
The Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals is achieved by completing six core and eight elective courses.
Books Books

Complete WHO Guidance Documentation Bundle

Member: $15.00 Nonmember: $22.50
A WHO bundle with six guidance documents addressing pharmaceuticals, medical devices, psychotropic substances and plasma.