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.
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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.
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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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On-demand On-demand
How to Integrate Risk Management Throughout the Lifecycle of a Medical Device in the Coming Decade
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will review the application of a modern approach to risk management as a product moves through the product lifecycle.
Books Books
From Alzheimer's to Zebrafish: Eclectic Science and Regulatory Stories
Member: $15.00 Nonmember: $20.00
This is an informative, enjoyable read for individuals involved in the fields of medicine and science and those with curious minds.
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2020 NMPA (CFDA) Key Updates and Look Ahead on 2021
1.0 RAC 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?
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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.
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Taking Advantage of the EU MDR Delay in Uncertain Times: Optimizing Your Medical Device RA/QA Strategy
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
Regulatory leaders from global medical device companies will share their perspective and lessons learned regarding the challenges - both past and future - related to EU MDR.
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Building Global Submissions from the Ground Up - SARS-CoV-2 Case Study
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Whether you are developing SARS-CoV-2 assays or are just interested how to efficiently build your global submissions, this webcast aims to share some of those best practices using SARS-CoV-2 as a case study.
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Learn to Comply With China's UDI Submissions Requirements
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
Overview of key UDI-related regulations, lessons learned from the first batch pilot, and guidance on how to comply with requirements.
On-demand On-demand
Achieving Medical Device Development Success Through Early Implementation of Regulatory, Reimbursement and Clinical Research Strategies
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn best practices and proven strategies to address challenges presented by today’s shifting regulatory environment and the keys to commercial success.