RoundupsRoundups
Euro Roundup: EMA seeks feedback on framework for incorporating patient views into regulatory decisions
Posted 21 October 2021 By Nick Paul Taylor
The European Medicines Agency (EMA) has reached a draft qualification opinion on a framework for incorporating patient views into regulatory decisions. The agency “generally endorsed” the proposed research framework and is now seeking fe...
Regulatory NewsRegulatory News
FDA issues proposed OTC hearing aid rule
Posted 19 October 2021 By Jeff Craven
The US Food and Drug Administration (FDA) has issued a long-awaited proposed rule to create a new regulatory category that would allow the sale of over-the-counter (OTC) hearing aids for adults with mild and moderate hearing loss.
Regulatory NewsRegulatory News
FDA says IRB review still needed for IVD studies involving human specimens
Posted 19 October 2021 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) reiterates that clinical studies of in vitro diagnostic devices (IVDs) using leftover, deidentified human specimens still have to be approved by Institutional Review Boards (IRBs).  
RoundupsRoundups
Asia-Pacific Roundup: TGA moves to make patient information rules more flexible after consultation
Posted 19 October 2021 By Nick Paul Taylor
Australia’s Therapeutic Goods Administration (TGA) is set to allow more flexibility in how medical device patient information materials are provided after holding a consultation into possible reforms.
ReconRecon
Recon: WHO aims to buy Merck COVID drug for $10 per pill; CDC study finds Pfizer vaccine highly effective against hospitalization in 12-18 year olds
Posted 19 October 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
EC updates Clinical Trial Regulation Q&As ahead of January go-live
Posted 18 October 2021 By Joanne S. Eglovitch
The European Commission has issued an updated question-and-answer guidance clarifying certain aspects of the Clinical Trials Regulation (CTR), which is set to go into effect this January.  
Regulatory NewsRegulatory News
Cyltezo approved as interchangeable biosimilar with Humira
Posted 18 October 2021 By Kari Oakes
An anti-inflammatory biosimilar from Boehringer-Englheim has received interchangeability designation from the US Food and Drug Administration (FDA). Cyltezo (adalimumab-adbm) is now both biosimilar to and interchangeable with Abbvie’s Hu...
ReconRecon
Recon: FDA approves Oyster Point's dry eye nasal spray; EMA reviewing Pfizer vaccine in young children
Posted 18 October 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Virtual Programs Virtual Programs
US Regulatory Essentials, Devices (November 2021)
Thursday, 18 November 2021 (10:00 - 4:00PM) 12.0 RAC Credits This online workshop offers a comprehensive overview of U.S. regulatory affairs for medical devices and IVDs. It will cover laws, regulations, FDA guidance, strategies for FDA submissions, advertising and labeling, post-market compliance, and more.
Virtual Programs Virtual Programs
RAPS UK LNG:2021 Recap and What to Expect in 2022
Tuesday, 23 November 2021 (5:00 - 6:30PM) 0.0 RAC Credits The RAPS UK Local Networking Group (UK LNG) is offering a series of complimentary webinars as part of its 2021 post-COVID Relaunch. You are invited to the last of three virtual events on the "2021 Recap and What to Expect in 2022".
Virtual Programs Virtual Programs
Artificial Intelligence: A Regulatory Perspective
Wednesday, 03 November 2021 (10:00 - 11:00AM) 1.0 RAC Credits 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 and explore emerging future challenges of AI.
Virtual Programs Virtual Programs
China NMPA Clinical Evaluation and Trial Key Changes to Support Order 739 Webcast
Thursday, 28 October 2021 (10:00 - 11:15AM) 1.5 RAC Credits 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, clinical evaluation principles and data appraisals.
Virtual Programs Virtual Programs
Europe Europe
REC Webcast: Supply chain management - latest developments from regulatory point of view
Tuesday, 09 November 2021 (4:30 - 5:45PM) 1.0 RAC Credits Member: € 10 Nonmember: € 25 This event is brought to you by the RAPS European Council (REC) to encourage knowledge sharing and community development. RAC holders may claim 1.0 RAC recertification credit.
Virtual Programs Virtual Programs
Rollercoaster Ride Ahead: Time Is Short for EU IVDR Transition
Wednesday, 10 November 2021 (10:00 - 3:30PM) 6.0 RAC Credits At this stage, manufacturers must be finalizing their transition plan for applying these new requirements to keep their devices in the EU market. Join this two-day workshop for help in developing a clearer path to your transition plan.
Virtual Programs Virtual Programs
Expedited Pathways (US/Global) – Medical Device
Monday, 15 November 2021 (8:30 - 4:15PM) 12.0 RAC Credits Led by a veteran regulatory manager, this workshop will focus on expedited pathways by FDA, EU, China NMPA and other regulatory agencies from major global markets as to map out a pathway to bring products to market as fast as possible.
Virtual Programs Virtual Programs
Sponsored Webcast: Three Real-World Experiences Using a Novel Data Platform
Tuesday, 26 October 2021 (12:00 - 1:30PM) 1.0 RAC Credits Member: $0 NonMember $0 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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Books Books
Complete GHTF Guidance Document Bundle
Member: $62.50 Nonmember: $82.50
A GHTF bundle of 24 guidances for medical devices: 10 from Study Group 1, eight from Study Group 2, three from Study group 3, two from Study Group 4 and one from Study Group 5.
On-demand On-demand
21 CFR 820 Quality System Regulation and ISO 13485 Medical Devices
1.5 RAC Credits
Member: $0.00 Nonmember: $35.00
The RAPS Philadelphia Chapter’s webcast covering 21 CFR 820 quality system regulation and ISO 13485 medical devices.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Medical Devices: Definition & Lifecycle [1.0 RAC]
1.0 RAC Credits
Member: $135.00 Nonmember: $185.00
This course acts as a primer—a basic introduction to medical devices and general aspects of product and regulatory lifecycles.
Online Course Online Course
Europe Europe
Medical Device Certificate Elective Medical Device Certificate Elective
Medical Devices: EU Regulations [5.0 RAC]
5.0 RAC Credits
Member: $545.00 Nonmember: $745
This course provides a solid understanding of medical device regulation in the EU. It covers the history of medical device regulation in Europe and follows the regulatory requirements throughout the product life.
RAC Prep Bundle RAC Prep Bundle
RAC (Devices) Reference Package: Complete Bundle
Member: $1,900 Nonmember: $2,600
Referred to as 'Reference Packages', RAC Prep bundles combine several of RAPS individual RAC prep tools together at a discounted rate.
Online Course Online Course
Single Certificate Single Certificate
Regulatory Affairs Certificate Upgrade: Pharmaceuticals
Member: $1225.00 Nonmember: $1580
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 (Hardcover)
Member: $125 Nonmember: $175
Learn to develop a comprehensive global regulatory strategy for medical devices, labeling, clinical, risk management, marketing, and postmarketing.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Medical Devices: Canadian Regulations [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course will provide a basic understanding of medical device regulations in Canada.