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...
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.
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...
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.
Regulatory NewsRegulatory News
Califf, experts eye legislative fix for accelerated approval program
Posted 19 January 2022 By Mary Ellen Schneider
Regulatory and industry experts agree that completing confirmatory studies quickly is essential to the success of the US Food and Drug Administration’s (FDA) accelerated approval program, with some suggesting that new legislation might b...
Regulatory NewsRegulatory News
Califf previews priorities if confirmed as FDA commissioner
Posted 18 January 2022 By Michael Mezher
In correspondence with two Republican senators before his nomination was advanced in the Senate last week, FDA Commissioner-nominee Robert Califf committed to promoting the use of real-world evidence (RWE) and cited the need for better p...
RoundupsRoundups
Asia-Pacific Roundup: TGA posts Q&A on conditions for supplying point-of-care rapid antigen COVID-19 tests
Posted 18 January 2022 By Nick Paul Taylor
Australia’s Therapeutic Goods Administration (TGA) has published a question and answer document on the conditions for supplying rapid antigen tests of COVID-19 at the point of care. TGA released the text within days of providing guidance...
Virtual Programs Virtual Programs
Integrating Human Factors into Your Next Regulatory Submission: Lemons or Lemonade?
Tuesday, 26 April 2022 (9:00 - 2:00PM) 6.0 RAC Credits Member: $495 | Nonmember: $580
This workshop is for the regulatory professional who wants to successfully navigate crucial aspects of human factors and prevent obstacles and risks to your submissions.
Virtual Programs Virtual Programs
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
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.
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
Virtual Programs Virtual Programs
Introduction to Regulatory Submissions in the eCTD Format - March 2022
Wednesday, 30 March 2022 (10:00 - 5:00PM) 12.0 RAC Credits Members: $825 | Nonmembers: $970
Join RAPS for a two-day workshop on regulatory submissions in eCTD format, discussing both the underlying CTD structure and their options for implementing operational changes for electronic applications.
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.
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
Biologics CMC: Phase Appropriate Product Development
Thursday, 17 March 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $825 | Nonmember: $970
Learn how to handle technical issues affecting biologic product development challenges and expectations in the US, Europe, and other highly regulated regions.
     
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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.
Product Bundle Product Bundle
Clinical Trial Foundations Bundle
Member: $575.00 Nonmember: $790.00
Improve your knowledge surrounding the proper conduct of clinical research with human subjects.
Product Bundle Product Bundle
GxP Bundle
Member: $865.00 Nonmember: $1,292.00
This three-course series examines essential topics within a quality system—Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP).
Product Bundle Product Bundle
Regulatory Medical Writing Bundle [Complete Package]
Member: $1,240.00 Nonmember: $1,710.00
Learn more about the components of various application types and techniques for improving document quality.
Product Bundle Product Bundle
Regulatory Basics Bundle - US & Canada
Member: $400.00 Nonmember: $560.00
This bundle provides fundamental information on product lifecycles, gives insight into professional roles and responsibilities and discusses regulatory mechanisms, processes and agencies within key markets.
Books Books
Eclectic Science and Regulatory Compliance: Stories for the Curious
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.
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
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Pharmaceuticals: Definition & Lifecycle [1.0 RAC]
1.0 RAC Credits
Member: $135.00 Nonmember: $185.00
This course also provides an introduction to the lifecycle of drug products, from discovery to on-market support.