Regulatory NewsRegulatory News
Experts: Lack of EU reference labs due to regulatory uncertainties, COVID workload
Posted 15 August 2022 By Ferdous Al-Faruque
The European Commission is having a difficult time getting member states to offer up European Union reference laboratories (EURLs) to review high-risk in vitro diagnostics (IVDs) under the In Vitro Diagnostic Medical Devices Regulation ...
Regulatory NewsRegulatory News
UK MHRA is first to authorize Moderna’s bivalent COVID-19 booster
Posted 15 August 2022 By Ferdous Al-Faruque
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Moderna’s bivalent COVID-19 booster vaccine for adults. The vaccine’s composition is split evenly between components targeting the original 2020 SARS-CoV-2 st...
Regulatory NewsRegulatory News
FDA warns two Massachusetts infusion pump makers owned by same CEO
Posted 15 August 2022 By Ferdous Al-Faruque
Two infusion pump manufacturers were handed similar warning letters for multiple issues, including failing to take adequate corrective actions after receiving product complaints, following up on those complaints and addressing product fa...
ReconRecon
Recon: UK’s MHRA is first to approve bivalent COVID booster; Brainstorm to seek FDA approval for ALS treatment, despite agency’s concerns
Posted 15 August 2022 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
This Week at FDAThis Week at FDA
This Week at FDA: Amazon warning letter, ANDA amendments, and more
Posted 12 August 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 take a look at warning letters sen...
Regulatory NewsRegulatory News
Expert: OGD on track to approve more generic drugs in FY2022
Posted 12 August 2022 By Joanne S. Eglovitch
The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) will most likely approve a higher number of generic drugs in FY2022 compared to the prior year, and the number of generic applications received may continue to exc...
Feature ArticlesFeature Articles
The value of a ready-to-use therapeutic food guideline for severe malnutrition
Posted 12 August 2022 By Louise T. Göttsche, MSc, MBA
Ready-to-use therapeutic foods (RUTFs) are used in the treatment of children with severe acute malnutrition (SAM) without medical complications. This article focuses on the value of an RUTF guideline. Knowing what is required for childre...
Regulatory NewsRegulatory News
FDA blasts California firm for multiple GLP issues involving nonclinical studies
Posted 11 August 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) found a slew of good laboratory practice (GLP) violations during the conduct of nonclinical studies at West Sacramento, CA firm Valley Biosystems in a 3 August warning letter and blasted the fi...
Virtual Programs Virtual Programs
China Drug Market Opening Up for Foreign Drug Makers
Tuesday, 16 August 2022 (11:00 - 12:30PM) 1.0 RAC Credits Member: $150 | NonMember: $175
This virtual program will provide regulatory professionals with helpful information, strategies, and insights about drug registration with China NMPA.
Chapter Events Chapter Events
Twin Cities Chapter Happy Hour
Thursday, 18 August 2022 (5:00 - 7:00PM) 0.0 RAC Credits Join us again as the RAPS Twin Cities Chapter hosts another summer Happy Hour!
Virtual Programs Virtual Programs
Sponsored Webcast: Advantages of Engaging Ahead: How Partnership & Collaboration Enable eCTD Submission Publishing Success
Wednesday, 24 August 2022 (11:00 - 12:00PM) 1.0 RAC Credits Member: $0 | NonMember: $0
Certara will demonstrate how how regulatory operations specialist were able to partner with Advaxis, Inc. to optimize regulatory operations processes.
Virtual Programs Virtual Programs
REC Webinar: Due Diligence
Friday, 09 September 2022 (4:00 - 5:15PM) 1.0 RAC Credits Learn how to approach Due Diligence with respect to acquisitions of products and intellectual property, requiring critical RA & QA/QMS competencies from both a buyers' and sellers' perspective, thereby guiding the process from both sides.
In-Person In-Person
RAPS Convergence 2022
Sunday, 11 September 2022 (8:00 - 5:00PM) 12.0 RAC Credits Members: $1,940 | Nonmembers: $2,255
Don’t Miss Regulatory’s Premiere Annual Event!
Virtual Programs Virtual Programs
Sponsored Webcast: A Regulatory and Strategic Framework for Facilitating Pediatric Drug Development
Thursday, 22 September 2022 (11:00 - 12:00PM) 1.0 RAC Credits Member: $0 | Nonmember: $0
During the webinar, pediatric development experts will provide an overview of the global regulatory framework and requirements that drive pediatric development.
Virtual Programs Virtual Programs
Biologics CMC: Phase Appropriate Product Development
Wednesday, 28 September 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $970 | NonMember: $1150
Learn how to handle technical issues affecting biologic product development challenges and expectations in the US, Europe, and other highly regulated regions.
Chapter Events Chapter Events
San Francisco Chapter Webcast: Cannabis: Where Are We Now?
Tuesday, 04 October 2022 (10:00 - 11:30AM) 1.5 RAC Credits Member: $0 |Nonmember: $25
This webcast will describe the terminology, and differences between FDA-approved and non-FDA approved cannabis, as well as an overview of current regulations of cannabis based products
     
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Books Books
Canadian Regulatory Acronyms & Definitions, Fifth Edition
Member: $10.00 Nonmember: $15.00
For those working in the Canadian market, entries of significance to the Canadian healthcare product industry.
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.
Books Books
Fundamentals of Japanese Regulatory Affairs, Second Edition (Japanese language)
Member: $55.00 Nonmember: $75.00
This Japanese language version covers premarket and postmarket requirements for healthcare products.
On-demand On-demand
Giving Voice to Regulatory Leadership
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn the professional development skills you need for success.
Online Course Online Course
Dual Certificate Dual Certificate
Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals (Dual)
Member: $3,590.00 Nonmember: $4,490.00
The Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals is achieved by completing six core and eight elective courses.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Globalization of Clinical Research Trials and Investigations [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course will cover regulatory requirements for conducting pivotal clinical trials in three countries that are often discussed as critical for global registration—China, India and Japan.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Effective Regulatory Communication [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
In this course, you will obtain an understanding of the complexities and principles of regulatory communication.
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.

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On-demand On-demand

The COVID-19 Impact: How will Regulatory Emerge from the Pandemic?

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
Learn how regulatory teams are adapting to this global health crisis and what effects it will have in the short and long term.
On-demand On-demand

Learn to Comply With China's UDI Submissions Requirements

1.5RAC 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

Meet the Authors, Regulatory Writing, Second Edition

1.0RAC Credits
Member: $0.00 Nonmember: $0.00
Hear from the experts who wrote the book on regulatory writing. Authors Lisa DeTora, Jocelyn Jennings and Jenny Grodberg will discuss the new edition’s writers-eye view of regulatory documentation.
Books Books

Regulatory Writing: An Overview, Second Edition

Member: $160.00 Nonmember: $225.00
This new edition is a valuable resource for professionals engaged in designing, composing, compiling, or commenting on regulatory documentation.
On-demand On-demand

Driving Innovation: Planning for CTD Submissions with Language Excellence

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
Language service providers can help pharmaceutical companies navigate CTD submissions required by recent regulatory changes in APAC countries such as China.
On-demand On-demand

Regulatory Policy & Intelligence: Understanding When, Why, and How to Invest in Growing These Capabilities

1.0RAC Credits
Member: $0 Nonmember: $20
Industry-leading regulatory experts will provide practical insights on how to assess RI needs, why this area is worth the investment, and how to build an RI strategy that fortifies the unique objectives of your company.
On-demand On-demand

Navigating Today’s Regulatory Trends to Successfully Manage eCTD Submissions

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will feature an overview of best practices to create successful eCTD submissions in a rapidly changing environment.
On-demand On-demand

Building Global Submissions from the Ground Up - SARS-CoV-2 Case Study

1.0RAC 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.
On-demand On-demand

Stay on Track and Get Some Sleep: Marketing Application Best Practices

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
Regulatory experts will offer tips and guidance for acceleration, submission leadership, and regulatory strategy from that you can apply to your marketing application to help ensure a successful submission.
Books Books

Global Medical Device Regulatory Strategy, Second Edition

Member: $205.00 Nonmember: $285.00
Learn to develop a comprehensive global regulatory strategy for medical devices, labeling, clinical, risk management, marketing, and postmarketing.