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
     
  •  
  • 1
  •  
  • 2
  •  
  • 3
  •  
  • 4
  •  
  •  
On-demand On-demand
Efficiency and Technology Pave the Way for the New Age of Narrative Writing
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
You will also learn how to add efficiency in your narrative process through the use of streamlined safety data reporting and implementation of technology.
On-demand On-demand
2020 NMPA (CFDA) Key Updates and Look Ahead on 2021
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
How can manufacturers or inventors be proactively prepared to shorten their time to market for new submissions, allow enough lead time for renewal, and to know when to file for modifications to avoid penalties?
On-demand On-demand
A Risk-Based Approach to Validation for Life Sciences Companies
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn how a risk-based validation approach can meet compliance requirements and maintain quality while streamlining the validation process.
Books Books
Regulatory Intelligence 101, Third Edition
Member: $130.00 Nonmember: $180.00
Comprised of 25 chapters from 30 experts from seven different countries, this new edition incorporates a global overview of regulatory intelligence.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Chemistry, Manufacturing and Controls (CMC) [5.0 RAC]
5.0 RAC Credits
Member: $545.00 Nonmember: $745.00
This course provides an overview of the CMC section of dossiers.
On-demand On-demand
Most Common Findings in EU Clinical Evaluations
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn the most common findings identified by Notified Bodies and by Qserve when performing a final CER review to the requirements of the MDR and MEDDEV 2.7/1 rev.4.
On-demand On-demand
The COVID-19 Impact: How will Regulatory Emerge from the Pandemic?
1.0 RAC 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
1.5 RAC 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.

All Results

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 Medical Writing Bundle [Package #1]

Member: $1,050.00 Nonmember: $1,440.00
Learn more about the components of various application types and techniques for improving document quality.
Product Bundle Product Bundle

Regulatory Basics Bundle - Complete

Member: $500.00 Nonmember: $700.00
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.
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

The Medical Device Validation Handbook, Second Edition

Member: $205.00 Nonmember: $285.00
The handbook covers device validation and revalidation throughout the product lifecycle, from design through postmarket.
On-demand On-demand

Understanding and Applying FDA’s 510(k) Modifications Guidance

1.5RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will review key aspects of the guidance, provide historical and other perspectives on its use, and present ideas on how to effectively implement it.
Books Books

Risk Management Principles for Devices and Pharmaceuticals

Member: $130.00 Nonmember: $180.00
Expanded and updated risk management information on healthcare products around the world.
On-demand On-demand

How to Better Manage Quality and Risk with a Global Change Control Strategy

1.5RAC Credits
Member: $0.00 Nonmember: $20.00
Learn about the contributing factors to building change control system that can help manage risk as well as metrics to consider to drive success.