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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On-demand On-demand
Meet the Author, International Combination Products, First Edition
Member: $0.00 Nonmember: $20.00
Hear from the expert who wrote the book!
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CMC - An Integral Component of Cell and Gene Therapy Development
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Experts from Cardinal Health Regulatory Sciences discuss CMC challenges and potential mitigation strategies illustrated through multiple case studies.
Books Books
The European Medical Device Regulation (2021 Update)
Member: $295.00 Nonmember: $395.00
Your “go-to” EU MDR guide and tool kit intended to be your companion to reference time and time again.
Books Books
International Combination Products
Member: $130.00 Nonmember: $180.00
This book provides an in-depth look at this breakthrough field and covers three major regulatory regions – the US, Canada, and Europe.
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PMCF User Feedback Surveys: Practical Solutions, Lessons Learned, and Processes for Success
1.5 RAC Credits
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This webcast will provide practical solutions to leveraging user feedback surveys as PMCF activities under the EU MDR, presented by former notified body leadership and PMCF subject matter experts.
RAC Exam RAC Exam
RAC Devices Examination Autumn 2022
Member: $490.00 Nonmember: $615.00
Testing Window :
31 October 2022 To 9 December 2022
Registration Deadline : 6 October 2022
RAC Exam RAC Exam
RAC Drugs Examination Autumn 2022
Member: $490.00 Nonmember: $615.00
Testing Window :
31 October 2022 To 9 December 2022
Registration Deadline : 6 October 2022
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Plan to Accelerate Your Time to Drug Submissions
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We'll discuss each stage of the submission, variations such as size of the development program, type of submission, and dealing with governance bodies.

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Are You Ready to Begin Planning your IND Submission?

1.0RAC Credits
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Regulatory experts will offer advice pertaining to selecting a target indication, seeking pre-IND advice from FDA, deciding whether to use US or non-US sites for early clinical research, and more.
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The Shifting Global Regulatory Landscape: Dealing with Regulatory Affairs in an Uncertain Environment

1.0RAC Credits
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This webcast will not try to predict how the geopolitical world will change as a consequence of COVID-19, but will cover current hot topics and emerging challenges affecting regulatory affairs professionals globally.
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PMS Requirements of the EU MDR: Implementation Challenges and Solutions

1.5RAC Credits
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This webcast will go into detail about strategies to overcome audit findings and gaps in your evidence.
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China NMPA & US FDA Emergency Approval – Implications to Life Science Companies Relating to COVID-19

1.5RAC Credits
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Our experts will explain related guidelines, emergency approval procedures, urgent importations, how they work in practice, what is required during the COVID-19 crisis, and what to expect moving forward.
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Best Practices for Building An Efficient Literature Review Process

1.0RAC Credits
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This webcast will review simple, pragmatic approaches and tools to focus on the high value work of CER preparation by reducing the time to complete low value administrative tasks.
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Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition

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This book presents a systematic approach to creating a global strategy to meet the requirements of multiple regulatory systems.
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Strategic Role of the RA Professional

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will demonstrate how the RA professional is a key strategic player starting with premarket planning and continuing through product development stages, manufacturing, and post market activities.
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EU MDR Prep: Translation Requirements That Will Make or Break Your Devices In Europe

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
The presenters will outline essential information and considerations for device manufacturers across the EU and explain everything you need to do to remain compliant.
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AI for Post Market Surveillance Compliance and Regulatory Work According to MDR

1.5RAC Credits
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Webcast registration includes access to handouts, presentation slides and the on-demand recording for one year.
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RAC (Drugs) Reference Package: Basic

Member: $400 Nonmember: $525
Purchase the Fundamentals of Medical Device Regulations book, RAC (Device) Practice Test and Flashcards together and save on these indispensable reference tools—our most popular products to help you prepare.