ReconRecon
Recon: Pharma industry laments Senate drug pricing bill; GSK, Mersana sign $1.4B preclinical ADC deal
Posted 09 August 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
ReconRecon
Recon: FDA approves first interchangeable biosimilar for Lucentis eye drug; Amgen to acquire ChemoCentryx for $4 billion
Posted 04 August 2022 By Joanne S. Eglovitch
Clinical Trials, Data Security Among US Federal Enforcement Priorities  Drug promotion enforcement so far similar under new FDA chief, with just 4 letters in first half of 2022  Accelerated Assessment Dry Spell Over As EMA Says Yes T...
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Recon: Roche CEO to step down after 14 years; WHO to roll out first malaria vaccine in Africa
Posted 21 July 2022 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
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Recon: FDA authorizes Novavax vaccine; EMA re-elected ICMRA chair
Posted 13 July 2022 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
ReconRecon
Recon: FDA to review first OTC birth control pill; EU recommends second COVID booster for over-60s
Posted 11 July 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
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Recon: FDA reconvenes adcomm meeting for Amylyx’s Pharma’s ALS treatment; AstraZeneca growing lymphoma pipeline with $1.3B TeneoTwo acquisition
Posted 05 July 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
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RAPS' LatestRAPS' Latest
Here’s what’s new in Fundamentals of Medical Device Regulations, Fifth Edition
Posted 01 July 2022 By Ryan Connors
Regulatory professionals need a new guide to medical device regulations. We just wrote one.
     
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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.
Virtual Programs Virtual Programs
Sponsored Webcast: A Regulatory and Strategic Framework for Facilitating Pediatric Drug Development
Thursday, 22 September 2022 (11:00 - 12:00PM) 1.0 RAC Credits Member: $0 | Nonmember: $0
During the webinar, pediatric development experts will provide an overview of the global regulatory framework and requirements that drive pediatric development.
Virtual Programs Virtual Programs
Sponsored webcast: Retrospective analysis of FDA’s Accelerated Approvals and conversions
Wednesday, 05 October 2022 (11:00 - 12:00PM) 1.0 RAC Credits Member: $0 | NonMember: $0
This session will cover a comprehensive analysis of the Accelerated Approval program as well as a deep dive into a selection of past examples and precedents.
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.
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.
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.
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
Introduction to the Due Diligence Process, Second Edition
Member: $75.00 Nonmember: $125.00
Explore modern elements of the due diligence process, including the changing focus of document review, and the role of regulatory counsel.
E-books E-books
Postapproval Changes for Drugs: A Practical Guide (e-book)
Member: $160.00 Nonmember: $225.00
This guide covers postapproval changes from marketing authorization transfers, administrative changes, late phase renewals through to additional indications.

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Books Books

International Combination Products

Member: $130.00 Nonmember: $180.00
This book provides an in-depth look at this breakthrough field and covers three major regulatory regions – the US, Canada, and Europe.
Online Course Online Course
Single Certificate Single Certificate

Regulatory Affairs Certificate: Pharmaceuticals

Member: $2360.00 Nonmember: $2950.00
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: Medical Devices

Member: $2360.00 Nonmember: $2950.00
The Regulatory Affairs Certificate: Medical Devices is achieved by completing four core and five elective courses.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective

Global Regulatory Strategy for Pharmaceuticals [4.0 RAC]

4.0RAC 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.
On-demand On-demand

IVDR 2022: What IVD manufacturers can learn from the MDR rollout

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
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 strategy.
Books Books

Global Pediatric Development of Drugs, Biologics, and Medical Devices

Member: $130.00 Nonmember: $180.00
This book takes a comprehensive look at global regulations, guidance, and incentives for the development of products for the pediatric population.
On-demand On-demand

China NMPA Clinical Evaluation and Trial Key Changes to Support Order 739 Webcast

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will explore the evolving regulations for China NMPA, reviewing regulations related to clinical evaluation, the main changes under Decree #739 in areas of clinical evaluation pathways.
On-demand On-demand

How to Better Manage Quality and Risk with a Global Change Control Strategy

1.5RAC Credits
Member: $0.00 Nonmember: $20.00
Learn about the contributing factors to building change control system that can help manage risk as well as metrics to consider to drive success.
Virtual Programs Virtual Programs

Sponsored Webcast: A Regulatory and Strategic Framework for Facilitating Pediatric Drug Development

Thursday, 22 September 2022 (11:00 - 12:00PM)
1.0RAC Credits
Member: $0 | Nonmember: $0
During the webinar, pediatric development experts will provide an overview of the global regulatory framework and requirements that drive pediatric development.
On-demand On-demand

Three Real-World Experiences Using a Novel Data Platform

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
This program will give you practical insights into new approaches and tools to help manage your business. It will cover 510(k) submission strategy, product code policy assessment, and postmarket safety analysis.