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Starting Friday, 26 November, save 20% on all books, e-books, RAPS Online University Certificate Programs and individual online courses now through Monday with discount code CYBERMONDAY20*.
Become a RAPS member or renew your membership between 26–29 November and receive a complimentary e-book of your choosing (up to a $175 value).
Looking to hire regulatory professionals? Save 20% on any job posting with code CYBERMONDAY20Post a job »
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.
ReconRecon
Recon: Pfizer touts long-term efficacy data for COVID vaccine in adolescents; House panel seeks interview with Hahn
Posted 22 November 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
TrackersTrackers
COVID-19 therapeutics tracker
Posted 19 November 2021 By Jeff Craven
Updated 19 November with new information on molnupiravir, ixagevimab and cilgavimab, Regkirona, casirivimab/imdevimab, Paxlovid plus ritonavir, sotrovimab, AT-527, Zyesami, Kevzara, ensovibep, and abivertinib.
Feature ArticlesFeature Articles
The RACE is on: Opportunities in pediatric oncology product development
Posted 19 November 2021 By Lisa Crose, PhD, RAC
Pediatric oncology patients continue to have significant unmet medical need. Although the Pediatric Research Equity Act (PREA) mandated evaluation of new drugs for pediatric patients, the rarity and uniquity of pediatric cancers allowed ...
ReconRecon
Recon: Novo Nordisk to buy Dicerna for $3.3B; US signs deal for $5.3B worth of Pfizer's COVID antiviral drug
Posted 18 November 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
FDA urged to endorse EPCIS to spur manufacturers' uptake of DSCSA
Posted 17 November 2021 By Joanne S. Eglovitch
The pharmaceutical industry and other trading partners told the US Food and Drug Administration (FDA) to endorse the use of Electronic Product Code Information Services (EPCIS) for tracing products through the supply chain by finalizing ...
ReconRecon
Recon: Biogen's Alzheimer's drug gets negative trend vote from EMA panel; EMA says Novavax authorization could come 'within weeks'
Posted 17 November 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Chapter Events Chapter Events
Wisconsin Chapter Webcast: Regulatory Landscape for Artificial Intelligence (AI)
Friday, 10 December 2021 (12:00 - 1:00PM) 1.0 RAC Credits Member: $10 Nonmember: $25
Learn the shortcomings of the current approaches at a national and international level to support standards and regulatory development needed to advance the use of Artificial Intelligence.
Chapter Events Chapter Events
New York/New Jersey Chapter Webcast: PDUFA VII
Thursday, 02 December 2021 (12:00 - 1:00PM) 1.0 RAC Credits Member: $10 Nonmember: $25
Learn about the soon reauthorized Prescription Drug User Fee Act (PDUFA VII) changes and what it means for the pharmaceutical and biopharmaceutical industries.
Virtual Programs Virtual Programs
Sponsored Webcast: Combination Products: Regulatory Approach and cGMP Requirements
Wednesday, 01 December 2021 (12:00 - 1:00PM) 1.0 RAC Credits Member: $0 Non Member: $0
This webinar will walk you through the regulatory approach and the new regulations applied for combination products.
Virtual Programs Virtual Programs
Rollout IVDR 2022: What can IVD manufacturers learn from the MDR rollout when establishing compliance for their IVD devices by May 2022?
Tuesday, 07 December 2021 (10:00 - 11:30AM) 1.0 RAC Credits Fee: $0
This webcast will cover the potential impact of IVDR implementation in 2022 for new and existing (legacy) devices and considerations learned from the MDR rollout for IVD manufacturers to consider when determining regulatory strategy
Virtual Programs Virtual Programs
COVID-19 In Vitro Diagnostics: A Look into FDA’s Regulatory Response
Thursday, 10 February 2022 (1:00 - 2:00PM) 1.0 RAC Credits Member: $0 NonMember: $0
This presentation will discuss the FDA Emergency Use Authorization Guideline and how the guidance has changed over time. It will cover the scientific basics of COVID-19, the biomarkers used to detect it, the types of tes
Chapter Events Chapter Events
RAPS Switzerland Chapter Event - Global Medtech Reimbursement Round Table
Tuesday, 30 November 2021 (3:00 - 5:30PM) 0.0 RAC Credits Members: $0 Nonmembers: $0
Hear from Payers, Providers and MedTech stakeholders for a discussion and exploration on global reimbursement and market access strategies. This is a free webcast hosted by the RAPS Switzerland chapter.
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.
In-Person In-Person
Europe Europe
Cybersecurity
Thursday, 17 February 2022 (9:00 - 5:00PM) 12.0 RAC Credits Members: € 945 Nonmembers: € 1120
Gain the knowledge you need to navigate global cybersecurity expectations, translate regulatory expectations into concrete design and development activities and establish trust with customers.
     
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Books Books
Global Medical Device Regulatory Strategy, Second Edition (Hardcover)
Member: $125 Nonmember: $175
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: $360 Nonmember: $475
Purchase the Fundamentals of Medical Device Regulations, Third Edition and RAC (Device) Practice Test together and save on these indispensable reference tools—our most popular products to help you prepare.
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.
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.
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.
Books Books
Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition (Hardcover)
Member: $125 Nonmember: $175
This book presents a systematic approach to creating a global strategy to meet the requirements of multiple regulatory systems.
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
Software as a Medical Device (Paperback)
Member: $125.00 Nonmember: $175.00
SaMD will help readers uncover whether their software is subject to global medical device regulations, understand the regulatory implications, and develop their SaMD strategy.

All Results

RAC Prep Bundle RAC Prep Bundle

RAC (Devices) Reference Package: Basic

Member: $360 Nonmember: $475
Purchase the Fundamentals of Medical Device Regulations, Third Edition and RAC (Device) Practice Test together and save on these indispensable reference tools—our most popular products to help you prepare.
Books Books

Global Medical Device Regulatory Strategy, Second Edition (Hardcover)

Member: $125 Nonmember: $175
Learn to develop a comprehensive global regulatory strategy for medical devices, labeling, clinical, risk management, marketing, and postmarketing.
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.
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.
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.
On-demand On-demand

The COVID-19 Impact: How will Regulatory Emerge from the Pandemic?

1.0RAC 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.

* RAPS Cyber Monday sale begins at 12:01 am on Friday, 26 November and ends at 11:59 PM EST on Monday, 29 November 2021. Offer may not be combined with any other promotions or discounts and may not be applied to prior purchases. 20% off promotion EXCLUDES RAPS Executive Development Program, RAC exam registration, RAC toolboxes, RAC prep bundles, individual RAC prep materials, RAPS Convergence, RAPS Euro Convergence, and RAPS live virtual programs.

Instructions for redeeming the promotional e-book offered with RAPS memberships and renewals purchased during the Cyber Monday sale will be included in the purchase receipt. This promotion is valid for a one-time download of an e-book valued up to $175 and expires at 11:59 PM EST on 31 December 2021.

Have questions? Please contact the RAPS solutions center by email at support@raps.org or by calling 301-770-2920 extension 200.