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
US Regulatory Essentials, Pharmaceuticals
Monday, 28 February 2022 (9:00 - 5:30PM) 6.0 RAC Credits Member: $495 |Nonmember: $580
An overview of laws, regulations and guidance affecting US regulation of biologics and pharmaceutical products, this workshop is for new -intermediate level professionals and those preparing for the RAC Drugs exam
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
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
Sponsored Webcast: E-labeling and Legislation: A Positive Impact on Patient Safety and Sustainability
Wednesday, 23 February 2022 (12:00 - 1:00PM) 1.0 RAC Credits Members: $0 | Nonmembers: $0
Attend this live broadcast and learn the essentials of e-PIL legislation, a pilot initiative between the pharm industry and regulatory authorities in Belgium and Luxembourg, supported by the European Commission
Virtual Programs Virtual Programs
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.
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
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.
Virtual Programs Virtual Programs
Biologics CMC: Phase Appropriate Product Development
Thursday, 21 July 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
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.
On-demand On-demand
US Regulation of Advertising and Promotion of Drugs
6.0 RAC Credits
Member: $399.00 Nonmember: $499.00
Examine the current requirements for advertising and promotion of healthcare products in the US, and how they impact the way you communication with healthcare professionals, consumers and managed care audiences
On-demand On-demand
US Regulation of Advertising, Promotion and Labeling for Medical Devices
6.0 RAC Credits
Member: $399.00 Nonmember: $499.00
Through presentations, discussions and case studies, this program will examine current guidelines and expectations for medical devices and how they impact the way you communicate with prospective and end users.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Pharmaceuticals: Advertising and Promotional Labeling in the US [4.0 RAC]
4.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course outlines the regulatory framework for prescription drug and biologic promotional materials by examining FDA regulations and issues involved in producing compliant promotional materials.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Medical Devices: US Regulations [5.0 RAC]
5.0 RAC Credits
Member: $545.00 Nonmember: $745.00
This course is intended to provide a basic overview of US medical device regulation.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Pharmaceuticals: US Regulations [5.0 RAC]
5.0 RAC Credits
Member: $545.00 Nonmember: $745.00
This course covers the requirements to obtain prescription and over-the-counter drug approvals and other requirements that are in place to ensure compliance with FDA regulations.
On-demand On-demand
How Huvepharma Maintains Quality and Innovation in a High Growth Environment
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn the need-to-know information for providing your promotional materials submissions in the eCTD format.
On-demand On-demand
Are you prepared for June 24th? FDA Promotional Materials Submissions in eCTD Format
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn the need-to-know information for providing your promotional materials submissions in the eCTD format.

All Results

Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective

Medical Devices: Advertising and Promotion in the US [3.0 RAC]

3.0RAC Credits
Member: $365.00 Nonmember: $500.00
This course provides information regarding the primary US agencies regulating medical devices and covers their enforcement tools as well as company strategies for avoiding enforcement actions.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective

Pharmaceuticals: Canadian Regulations [6.0 RAC]

6.0RAC Credits
Member: $570.00 Nonmember: $790.00
This course will introduce you to essential areas of regulatory knowledge for a broad range of pharmaceutical, radiopharmaceutical and biologic products in Canada.