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...
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...
ReconRecon
Recon: Pfizer says Paxlovid appears effective against omicron; Unilever ends pursuit of GSK consumer arm
Posted 19 January 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
FDA extends temporary halt in inspections driven by omicron
Posted 19 January 2022 By Michael Mezher
The US Food and Drug Administration (FDA) has extended its temporary pause on non-mission-critical domestic surveillance inspections through 4 February 2022, an agency spokesperson told Focus on Wednesday.
Virtual Programs Virtual Programs
US Regulatory Essentials, Devices
Tuesday, 22 March 2022 (10:00 - 3:30PM) 12.0 RAC Credits Members: $825| Nonmembers: $970
This online workshop offers a comprehensive overview of U.S. regulatory affairs for medical devices and IVDs.
Europe Europe
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Rollout IVDR 2022: How to prepare for the IVDR by May 2022. Date of Application or Dead on Arrival?
Wednesday, 23 March 2022 (1:00 - 5:00PM) 12.0 RAC Credits Member: € 710 | Nonmember: € 835
Learn which aspects to consider when writing a regulatory plan, along with several pathways to speed up development, including PRIME and adaptive pathways.
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Digital Health: Fundamentals of FDA Regulation
Friday, 11 February 2022 (11:00 - 12:30PM) 1.5 RAC Credits Members: $160 | Nonmembers: $175
Examine how FDA regulates digital health including SaMD, AI/ML and cybersecurity, and learn about the implications of the new FDA draft guidance on recommended software documentation for premarket submissions.
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Cybersecurity Unauthorized
Tuesday, 08 March 2022 (10:00 - 5:00PM) 12.0 RAC Credits Members: $970 | Nonmembers: $1,150
This workshop will help regulatory and quality professionals develop the knowledge they need to help steer their organizations in the right direction when it comes to global cybersecurity expectations.
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Preparing to Take the RAC Devices Exam
Tuesday, 15 March 2022 (5:00 - 8:30PM) 6.0 RAC Credits Members: $495 |Non-members: $580
For those preparing to take the RAC Devices exam. Workshop will focus on critical, analytical & strategic test-taking skills and be facilitated by a panel of regulatory professionals who have earned their RAC.
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2021 China NMPA (CFDA) Key Updates and 2022 Forecast
Monday, 28 February 2022 (10:00 - 11:00AM) 1.0 RAC Credits Members: $0 | Nonmembers: $0
This webcast will show how manufacturers can expedite the path to market for new China NMPA submissions. It will cover Order 739, when to file for modifications, how to keep medical devices compliant, and more.
Virtual Programs Virtual Programs
Navigating Strategies for Postmarket Clinical Follow-up
Tuesday, 15 March 2022 (8:00 - 10:00AM) 2.0 RAC Credits Members: $230 | Nonmembers: $270
This workshop will walk you through a clear process to effectively planning your PMCF activity that fits your product portfolio.
Virtual Programs Virtual Programs
Learn the Ins & Outs of China NMPA E-Filing
Wednesday, 23 March 2022 (10:00 - 1:00PM) 6.0 RAC Credits Members: $495|Nonmembers: $580
China NMPA Order 739 introduced a series of changes in NMPA medical device registration requirements. This workshop will provide an overview of updated requirements for electronic medical device and IVD submissions
     
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Books Books
Fundamentals of Canadian Pharmaceutical, Biologic and Medical Devices Regulations
Member: $100.00 Nonmember: $150.00
A compilation of Fundamentals of Canadian Pharmaceutical and Biologics Regulations and Fundamentals of Canadian Medical Device Regulations.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Global Regulatory Strategy for Medical Devices [4.0 RAC]
4.0 RAC Credits
Member: $465.00 Nonmember: $640.00
This course provides a basic description of global regulatory strategy for medical devices and explains the relationships between regulatory strategy and product development.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Medical Devices: Corrections, Removals and Directed Recalls [6.0 RAC]
6.0 RAC Credits
Member: $570.00 Nonmember: $790.00
This course examines compliance with US FDA, Health Canada, and European Union requirements and regulations.
On-demand On-demand
Understanding and Applying FDA’s 510(k) Modifications Guidance
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will review key aspects of the guidance, provide historical and other perspectives on its use, and present ideas on how to effectively implement it.
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.
Books Books
Promotion of FDA-Regulated Medical Products
Member: $130.00 Nonmember: $180.00
This book expands on RAPS’ 2013 publication, FDA Requirements for Prescription Drug Promotion by John Driscoll, to include prescription devices.
Books Books
The Medical Device Validation Handbook, Second Edition
Member: $205.00 Nonmember: $285.00
The handbook covers device validation and revalidation throughout the product lifecycle, from design through postmarket.
Books Books
Risk Management Principles for Devices and Pharmaceuticals
Member: $130.00 Nonmember: $180.00
Expanded and updated risk management information on healthcare products around the world.