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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 ...
Regulatory NewsRegulatory News
EU official says ICH Q6B is outdated and needs revision
Posted 01 December 2021 By Joanne S. Eglovitch
The International Council for Harmonization’s (ICH) Q6B guideline setting acceptance criteria for new biological products needs to be revised to incorporate a more patient-centric approach and to include the science and risk-based concep...
RoundupsRoundups
FDA Approvals Roundup: Cytalux, Lyvispah, Caldolor
Posted 01 December 2021 By Renee Matthews
A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
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.
Regulatory NewsRegulatory News
Public-private initiative expands support for NGS tests
Posted 30 November 2021 By Kari Oakes
A key microbial genome database is being updated and expanded through a public-private partnership, as the US Food and Drug Administration (FDA) works with a health data company and an academic institution to build out the FDA-ARGOS data...
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...
Regulatory NewsRegulatory News
Experts: Penumbra recall highlights ‘device creep,’ makes case for regulatory reform
Posted 30 November 2021 By Mary Ellen Schneider
The recent class I recall of a Penumbra cardiac device used in mechanical thrombectomy procedures provides a case study for the shortcomings of the current 510(k) medical device clearance process and the need for more robust device adver...
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.
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.
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.
Chapter Events Chapter Events
Atlanta Chapter: Annual Breakfast with the Atlanta Southeast FDA District Office
Friday, 03 December 2021 (9:00 - 11:00AM) 2.0 RAC Credits Member: $10 Nonmember: $25
Join us for a virtual breakfast to engage with the Atlanta Southeast FDA District Office representatives and get your hard-pressed questions answered.
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.
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
Sponsored Webcast: The Evolving Regulatory Real-World Evidence Landscape: Understanding FDA's 2021 RWE Guidance
Thursday, 09 December 2021 (10:00 - 11:30AM) 1.0 RAC Credits Member: $0 NonMember: $0
Join a discussion on FDA’s RWE guidance landscape, including how new draft guidance fits into the current ecosystem and implications for biopharma organizations as they develop evidence generation strategies.
Virtual Programs Virtual Programs
FDA Forecast: What’s Next for the FDA in 2022?
Thursday, 09 December 2021 (12:00 - 1:30PM) 1.5 RAC Credits Member: $0 NonMember: $0
In this webcast, AgencyIQ’s regulatory intelligence team will explore the top regulatory issues and challengers they expect the FDA and life sciences industry to encounter next year.
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.
     
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Books Books
Fundamentals of International Regulatory Affairs, Fifth Edition (Hardcover)
Members: $295 Nonmembers: $395
This edition discusses regulatory changes that have occurred globally and technologically with a focus on drugs and medical devices.
On-demand On-demand
China NMPA Medical Device Latest & Most Important Policy: Key Highlights of Order 739
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Review the key highlights of this new policy and the implications for overseas companies in premarket submission clinical and technical requirements, innovation focus, MAH and post market changes.
On-demand On-demand
China NMPA (CFDA) Regulatory Approval: Clinical Evaluation and Pathways
6.0 RAC Credits
Member: $480.00 Nonmember: $540.00
This workshop will cover different clinical evaluation and pathways and how to decide which pathway to choose to support China NMPA medical device/IVD regulatory approval or postmarket study requirements.
On-demand On-demand
Meet the Author, International Combination Products, First Edition
Member: $0.00 Nonmember: $20.00
Hear from the expert who wrote the book!
On-demand On-demand
CMC - An Integral Component of Cell and Gene Therapy Development
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Experts from Cardinal Health Regulatory Sciences discuss CMC challenges and potential mitigation strategies illustrated through multiple case studies.
Books Books
The European Medical Device Regulation (2021 Update) (Paperback)
Member: $295.00 Nonmember: $395.00
Your “go-to” EU MDR guide and tool kit intended to be your companion to reference time and time again.
On-demand On-demand
PMCF User Feedback Surveys: Practical Solutions, Lessons Learned, and Processes for Success
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will provide practical solutions to leveraging user feedback surveys as PMCF activities under the EU MDR, presented by former notified body leadership and PMCF subject matter experts.
Books Books
International Combination Products (Paperback)
Member: $125.00 Nonmember: $175.00
This book provides an in-depth look at this breakthrough field and covers three major regulatory regions – the US, Canada, and Europe.

All Results

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 clarify the terminology and concepts under the umbrella term Artificial Intelligence and how it differs from standard software.
On-demand On-demand

Combination Products: Regulatory Approach and cGMP Requirements (On-demand)

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
This webinar will walk you through the regulatory approach and the new regulations applied for combination products.
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.
E-books E-books

Orphan Drug Development for Rare Diseases (e-book)

Member: $130.00 Nonmember: $180.00
Orphan Drug Development for Rare Diseases covers every aspect of orphan drug development. Topics include incentives, benefits, patient engagement, designation, marketing authorization, and market access.
On-demand On-demand

Artificial Intelligence: A Regulatory Perspective

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will clarify the terminology and concepts under the umbrella term Artificial Intelligence and how it differs from standard software.
On-demand On-demand

Combination Products: Regulatory Approach and cGMP Requirements

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
Language service providers can help pharmaceutical companies navigate CTD submissions required by recent regulatory changes in APAC countries such as China.
On-demand On-demand

Understanding Key Components of a Clinical Evaluation

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
This broadcast will explain the key changes of clinical evaluation, review phases for clinical evaluation, explain expectations for systematic literature review, and identify types of clinical support data.
On-demand On-demand

The Aftermath of MDR

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will clarify the terminology and concepts under the umbrella term Artificial Intelligence and how it differs from standard software.
On-demand On-demand

Three Real-World Experiences Using a Novel Data Platform

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will clarify the terminology and concepts under the umbrella term Artificial Intelligence and how it differs from standard software.
On-demand On-demand

How Huvepharma Maintains Quality and Innovation in a High Growth Environment

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
Learn the need-to-know information for providing your promotional materials submissions in the eCTD format.