Regulatory NewsRegulatory News
CDRH outlines plan to understand sex and gender differences in medical devices
Posted 21 January 2022 By Mary Ellen Schneider
“Now more than ever, we need to understand the implications sex and gender present for the performance of medical devices in all individuals. The CDRH Health of Women program is a comprehensive, collaborative, landmark program built on t...
TrackersTrackers
COVID-19 therapeutics tracker
Posted 21 January 2022 By Jeff Craven
Updated 21 January to include new information on Olumiant, Lagevrio, Regkirona, Paxlovid, Xevudy, Veklury, and ensovibep.
Regulatory NewsRegulatory News
This Week at FDA: Generic drug approvals continue downward trend, new guidance on clinical trial diversity coming
Posted 21 January 2022 By Michael Mezher
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation and what we’re reading from around the web. This week, we look at some newly published data f...
Regulatory NewsRegulatory News
European Parliament endorses legislation bolstering EU’s ability to tackle shortages
Posted 20 January 2022 By Joanne S. Eglovitch
The European Parliament approved legislation to increase the powers of the European Medicines Agency (EMA) in monitoring and responding to drug and device shortages.
ReconRecon
Recon: 27 firms to manufacture Merck’s COVID pill; Blood sample collection tubes land on FDA device shortage list
Posted 20 January 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
FDA offers examples of innovative study designs accepted into CID pilot
Posted 20 January 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) recently highlighted three case studies showing how sponsors can incorporate innovative study designs in their clinical trials using the agency’s Complex Innovative Trial Designs (CID) pilot meet...
RoundupsRoundups
Euro Roundup: MHRA seeks feedback on proposals for the future of UK clinical trial legislation
Posted 20 January 2022 By Nick Paul Taylor
The Medicines and Healthcare products Regulatory Agency (MHRA) is holding a consultation into the future of clinical trial legislation in the UK. MHRA is seeking feedback on tens of proposals intended to streamline processes and remove u...
RoundupsRoundups
FDA Approvals Roundup: Ryaltris, Cibinqo, Rinvoq
Posted 19 January 2022 By Renee Matthews
A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
Virtual Programs Virtual Programs
Software as a Medical Device
Tuesday, 25 January 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $970 |Nonmember: $1,150
Join regulatory experts to explore evolving global regulatory requirements affecting SaMD, including determining when software is considered regulated as SaMD and how to determine correct class/classification.
Virtual Programs Virtual Programs
Dangerous Documents: Avoiding Land Mines in Your Records and Emails
Thursday, 27 January 2022 (8:00 - 9:30AM) 1.5 RAC Credits Members: $175 | Nonmembers: $200
Learn to analyze and revise written documents to protect yourself and your organization from unwelcome surprises. *Global Time Zones* 08:00 (Washington, DC) / 14:00 (Brussels) / 21:00 (Hong Kong)
Chapter Events Chapter Events
San Francisco Chapter: IVDs and Diagnostics APAC-Regulatory Hot Topics Round-up Part I
Monday, 31 January 2022 (5:00 - 6:00PM) 1.0 RAC Credits Member: $0 |Nonmember: $25
Learn about In Vitro Diagnostics (IVDs) and Diagnostics APAC-Regulatory hot topics
Chapter Events Chapter Events
Wisconsin Chapter Webcast: Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices
Tuesday, 01 February 2022 (2:00 - 3:00PM) 1.0 RAC Credits Member: $0 | Nonmember: $25
Learn new best practices and thinking to software and hardware computing technologies and embrace a more modern approach to device safety.
Chapter Events Chapter Events
Ontario Chapter Webcast: Legislative, Regulatory & Municipal Monitoring using Gnowit
Friday, 04 February 2022 (12:00 - 1:00PM) 1.0 RAC Credits Member: $0 | Nonmember: $25
Insights on monitoring policy updates in Canada using Artificial Intelligence & Machine Learning technologies.
Virtual Programs Virtual Programs
Preparing to Take the RAC Drugs Exam
Tuesday, 08 February 2022 (11:00 - 4:00PM) 12.0 RAC Credits Members: $970 |Non-members: $1,150
Designed specifically for those preparing to take the RAC Drugs exam, workshop will be facilitated by a panel of RAC-certified regulatory professionals and focuses on sharpening strategic test-taking skills.
Virtual Programs Virtual Programs
Strategies in Meetings: Achieving Your Objectives
Thursday, 10 February 2022 (8:00 - 9:30AM) 1.5 RAC Credits Members: $150 | Non-members: $175
Discover ten techniques that will improve your ability to persuade others to pursue a course of action. *Global Time Zones* 08:00 (Washington, DC) / 14:00 (Brussels) / 21:00 (Hong Kong)
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 Members $0 | Nonmenbers $0 This presentation will discuss the FDA Emergency Use Authorization Guideline and how the guidance has changed over time.
     
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On-demand On-demand
Sponsored Webcast: Combination Products: Regulatory Approach and cGMP Requirements (On-demand)
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webinar will walk you through the regulatory approach and the new regulations applied for combination products.
On-demand On-demand
Impact of MDR on Drug-Device Combination Products: Notified Body Opinion and CE Mark Applications (On-Demand)
6.0 RAC Credits
Member: $480 Non-Member: $540
Learn how EU MDR 2017/745 affects integral drug-device combinations and how to develop a complete dossier for Notified Body review.
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 (On Demand)
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will provide an overview of terminology and concepts in Artificial Intelligence, review the regulatory requirements in the EU market, cover real-world examples of commercial solutions
On-demand On-demand
Understanding Key Components of a Clinical Evaluation
1.0 RAC 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
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Delve into the challenges that Notified Bodies and industry are experiencing during the transition from MDD to MDR. Glean expertise from the industry’s early adopters with real-world examples
On-demand On-demand
Three Real-World Experiences Using a Novel Data Platform
1.0 RAC 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.

All Results

On-demand On-demand

SaMD Product Development: Addressing Challenges through Early Integration of Regulatory, Quality and Clinical Data Strategies

Member: $0.00 Nonmember: $20.00
This webcast will focus on best practices and proven strategies to address challenges presented by today’s shifting SaMD regulatory environment, and discuss the keys to commercial success.
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

Purity is a Virtue: A Practical Guide to the Reporting of Impurities

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
Increase your understanding of the regulatory guidances (e.g., ICH, FDA, and EMA) available on impurities, including key take-away messages.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective

Regulation of IVDs in the US and Major Markets Outside the US [5.0 RAC]

5.0RAC Credits
Member: $545.00 Nonmember: $745.00
This course provides a basic overview of IVDs, including an historical background focused on regulatory requirements. It introduces key regulations and guidelines necessary for effective product development.
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

An Essential Guide to Horizontal Role Change Thinking

Member: $95 Nonmember: $105
Sometimes the next step in one's career is not in the next-level role, but in something else. This tutorial will help you demonstrate that you can undertake a different role.
Online Course Online Course

An Essential Guide to Vertical Career Thinking

Member: $95 Nonmember: $105
This tutorial seeks to reframe one's thinking about expected performance. Providing insights which are typically absent or unclear from position descriptions.
On-demand On-demand

Efficiency and Technology Pave the Way for the New Age of Narrative Writing

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
You will also learn how to add efficiency in your narrative process through the use of streamlined safety data reporting and implementation of technology.
On-demand On-demand

2020 NMPA (CFDA) Key Updates and Look Ahead on 2021

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
How can manufacturers or inventors be proactively prepared to shorten their time to market for new submissions, allow enough lead time for renewal, and to know when to file for modifications to avoid penalties?
On-demand On-demand

A Risk-Based Approach to Validation for Life Sciences Companies

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
Learn how a risk-based validation approach can meet compliance requirements and maintain quality while streamlining the validation process.