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Feature ArticlesFeature Articles
FDA guidances for medical device regulation after enforcement discretion and EUA expiration
Posted 23 May 2022 By Ashley Clark, MS, RAC
This article summarizes the requirements for transitioning medical devices, marketed with lowered standards for effectiveness under emergency use authorization (EUA) during the COVID-19 pandemic, after the EUA declaration expires.  Keyw...
ReconRecon
Recon: Pfizer, BioNTech seek vaccine EUA for children under 5; EU authorizes AstraZeneca COVID booster
Posted 23 May 2022 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
TrackersTrackers
COVID-19 therapeutics tracker
Posted 20 May 2022 By Jeff Craven
Updated 20 May with new information on Paxlovid, Veklury (remdesivir), Xevudy (sotrovimab), Olumiant/Baricinix (baricitinib), and Gleevec/Glivec (imatinib).
ReconRecon
Recon: Senate user fee bill omits accelerated approval measures; NIH to study longer course of Paxlovid to combat reinfections
Posted 18 May 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
FDA, EMA officials discuss impediments to cell and gene therapies
Posted 17 May 2022 By Joanne S. Eglovitch
The US Food and Drug Administration’s (FDA) top biologics regulator said the use of a  “playbook” or platform approach for developing multiple cell and gene therapy products and a globally harmonized template would facilitate the develop...
ReconRecon
Recon: FDA authorizes Pfizer COVID booster for children 5-11; AstraZeneca strikes $157M licensing deal with RQ Bio
Posted 17 May 2022 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
ReconRecon
Recon: Lilly scores approval for next-gen type 2 diabetes drug; FDA’s RWE pilot cites challenges in emulating RCTs
Posted 16 May 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
ReconRecon
Recon: Moderna completes EUA submission for younger kids and adolescents; Generic firms to cap price of Paxlovid copies at $25 in low-income countries
Posted 12 May 2022 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Virtual Programs Virtual Programs
Preparing to Take the RAC Drugs Exam
Tuesday, 04 October 2022 (11:00 - 4:00PM) 12.0 RAC Credits Members: $970 NonMembers: $1,150
Designed specifically for those preparing to take the RAC Drugs exam. This workshop will be facilitated by a panel of RAC-certified regulatory professionals and focuses on sharpening strategic test-taking skills.
Chapter Events Chapter Events
NY/NJ Chapter Webcast: Panel Discussion on Leadership Journeys: Navigating Career Paths in Regulatory Affairs
Tuesday, 07 June 2022 (12:00 - 1:30PM) 1.5 RAC Credits Member: $0 NonMember: $25
Join us for a panel discussion by six Women Leaders who have navigated and overcome barriers to chart paths for themselves and others in RA.
Virtual Programs Virtual Programs
The Digital Transformation of MedTech Regulatory Affairs
Thursday, 16 June 2022 (11:00 - 12:30PM) 1.5 RAC Credits Members: $175| Nonmembers: $200
Learn how organizations can respond to the growing adoption of digital solutions by global regulatory agencies and how to process a higher volume of submissions, while improving data quality and consistency.
Chapter Events Chapter Events
Colorado Chapter Webcast: Best Practices for Management of Companion Diagnostics (CDx) Partnerships
Thursday, 23 June 2022 (4:00 - 5:00PM) 1.0 RAC Credits Member: $0 NonMember: $25
This program will cover the key elements and strategies for effective management of Companion Diagnostics.
In-Person In-Person
RAPS Convergence 2022
Sunday, 11 September 2022 (8:00 - 5:00PM) 12.0 RAC Credits Members: $1,940 | Nonmembers: $2,255
Don’t Miss Regulatory’s Premiere Annual Event!
In-Person In-Person
The Evolving Global UDI Requirements
Wednesday, 29 June 2022 (9:00 - 4:00PM) 12.0 RAC Credits Members: $1,300 | Nonmembers: $1,525
In this two-day, in-person workshop, regulatory experts will cover global UDI requirements and their impact on device manufacturers.
In-Person In-Person
Cybersecurity Unauthorized
Monday, 27 June 2022 (9:00 - 5:00PM) 12.0 RAC Credits Members: $1,300 | Nonmembers: $1,525
In this two-day, in-person workshop, regulatory experts will develop the knowledge they need to help steer their organizations in the right direction when it comes to global cybersecurity expectations.
In-Person In-Person
Software as a Medical Device
Wednesday, 29 June 2022 (9:00 - 5:00PM) 12.0 RAC Credits Members: $1,300 | Nonmembers: $1,525
In this two-day, in-person workshop, regulatory experts will review current and evolving regulatory requirements for software as a medical device to navigate the challenging expectations for software products
     
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Books Books
Global Medical Device Regulatory Strategy, Second Edition
Member: $205.00 Nonmember: $285.00
Learn to develop a comprehensive global regulatory strategy for medical devices, labeling, clinical, risk management, marketing, and postmarketing.
RAC Prep Bundle RAC Prep Bundle
RAC (Devices) Reference Package: Basic
Member: $400 Nonmember: $525
Purchase the Fundamentals of Medical Device Regulations book, RAC (Devices) Flashcards and Practice Test together and save on these indispensable reference tools—our most popular products to help you prepare.
Online Course Online Course
Single Certificate Single Certificate
Regulatory Affairs Certificate Upgrade: Medical Devices
Member: $1230 Nonmember: $1540
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.
Online Course Online Course
Single Certificate Single Certificate
Regulatory Affairs Certificate Upgrade: Pharmaceuticals
Member: $1230.00 Nonmember: $1540
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.
On-demand On-demand
The COVID-19 Impact: How will Regulatory Emerge from the Pandemic?
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn how regulatory teams are adapting to this global health crisis and what effects it will have in the short and long term.
Books Books
Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition
Member: $160.00 Nonmember: $225.00
This book presents a systematic approach to creating a global strategy to meet the requirements of multiple regulatory systems.
On-demand On-demand
Meet the Authors, Regulatory Intelligence 101, Third Edition
Member: $0.00 Nonmember: $0.00
The three leading authors will answer your questions on why this book needed to be revised and why all regulatory intelligence (RI) professional can benefit from this update.
Books Books
Software as a Medical Device
Member: $145.00 Nonmember: $200.00
SaMD will help readers uncover whether their software is subject to global medical device regulations, understand the regulatory implications, and develop their SaMD strategy.