This Week at FDAThis Week at FDA
This Week at FDA: User fee timeline, bivalent boosters, and more
Posted 01 July 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. The biggest news out of FDA this week was the ag...
Feature ArticlesFeature Articles
Supply chain disruptions: FDA guidance and temporary policies
Posted 30 June 2022 By Tony Subketkaew, JD, Joanna Pearce, JD
The COVID-19 pandemic caused one of the most prominent displays of supply chain disruption in the modern era. However, the US Food and Drug Administration (FDA) found ways to allow for regulatory flexibility by issuing guidance documents...
Feature ArticlesFeature Articles
An update of China’s food safety regulatory framework
Posted 30 June 2022 By Junshi Chen, MD, Chunzhu Wu, MSc
This article reviews the changes in China's national food safety control system and update on national food safety standard system and describes the country's unique regulations and requirements for the regulatory control of infant formu...
Regulatory NewsRegulatory News
ICMRA explores hybrid inspections, postapproval changes with new pilots
Posted 29 June 2022 By Joanne S. Eglovitch
A global regulatory group is seeking industry participants for two pilot programs exploring a common regulatory framework for assessing manufacturing facilities in hybrid inspections and for reviewing postapproval changes.  
Regulatory NewsRegulatory News
CAR T cell product development guidance: Comments ask for CMC details
Posted 29 June 2022 By Mary Ellen Schneider
Both industry and clinicians asked the US Food and Drug Administration (FDA) for clarification related to the evaluation of cellular starting materials in its draft guidance on chimeric antigen receptor (CAR) T cell product development.
ReconRecon
Recon: EU approves two Sanofi treatments for rare diseases; Novartis to cut 8,000 staffers as part of global reorganization
Posted 28 June 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
RF Quarterly, June 22: Regulatory history
Welcome to the June issue of RF Quarterly in which global regulatory experts write about Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), medical device regulations in China’s National Medical Products Administration (NMPA), an...
Evolution of the Japanese regulatory system and agencies
Posted 27 June 2022 By Susumu Nozawa, RAC, FRAPS
Over the last 6 decades, the Japanese regulator has faced many challenges but has kept enhancing the system based on learnings from the challenges. This article traces the origin of the Japanese regulatory system and the significant even...
Virtual Programs Virtual Programs
China NMPA Medical Device Regulations & NEW Revisions and Guidance
Monday, 07 November 2022 (8:00 - 12:00PM) 12.0 RAC Credits Member: $825 NonMember: $970
This interactive, three-day program will explore the fundamentals of Chinese NMPA regulations for medical devices, emphasizing updated revisions and guidance released within the last two years.
Virtual Programs Virtual Programs
Biologics CMC: Phase Appropriate Product Development
Thursday, 21 July 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $970 | Nonmember: $1,150
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
Sponsored Webcast: FDA QMSR: What do the Proposed Changes Mean for Industry?
Wednesday, 03 August 2022 (10:00 - 11:00AM) 1.0 RAC Credits Member: $0 | NonMember: $0
In this webcast, experts will review the history of quality systems, look at the changes to quality regulations, and discuss the FDA’s intent to adopt the ISO 13485 standard.
Europe Europe
In-Person In-Person
Software as a Medical Device
Tuesday, 18 October 2022 (9:00 - 5:00PM) 12.0 RAC Credits Members: € 1,080 | Nonmembers: € 1,265
Review current and evolving regulatory requirements for software as a medical device in order to navigate the challenging expectations for software products.
In-Person In-Person
Europe Europe
Regulatory Leadership
Thursday, 20 October 2022 (9:00 - 5:00PM) 0.0 RAC Credits Members: €1080 | Nonmembers: €1265
Learn the typical career routes you can take as a Regulatory professional. This workshop will increase your awareness of what leadership means, particularly when it comes to Regulatory and Quality.
Chapter Events Chapter Events
Indiana Chapter Webcast: Challenges and Lessons Learned from Both an Industry and Notified Body Perspective for the Implementation of EU Regulations
Tuesday, 26 July 2022 (3:30 - 5:00PM) 1.5 RAC Credits Member: $0 NonMember: $25
Join regulatory professionals for an overview of key learnings obtained on the journey to MDR and IVDR certification.
Europe Europe
In-Person In-Person
Cybersecurity
Thursday, 20 October 2022 (9:00 - 5:00PM) 12.0 RAC Credits Members: €1080 | Nonmembers: €1265
Gain the knowledge you need to navigate global cybersecurity expectations, translate regulatory expectations into concrete design and development activities and establish trust with customers.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Medical Devices: Postmarket Surveillance [4.0 RAC]
4.0 RAC Credits
Member: $465.00 Nonmember: $640.00
This course highlights the requirements and importance of an effective postmarket surveillance program that satisfies the regulatory and quality system requirements in the US, Canada and Europe.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Medical Devices: EU Regulations [5.0 RAC]
5.0 RAC Credits
Member: $545.00 Nonmember: $745
This course provides a solid understanding of medical device regulation in the EU. It covers the history of medical device regulation in Europe and follows the regulatory requirements throughout the product life.
Online Course Online Course
Ethics--Essential Tools for Regulatory Professionals [4.0 RAC]
4.0 RAC Credits
List Price: $640 Member: $465
This course identifies and analyzes ethical issues regulatory professionals may encounter and provides a general introduction to complex concepts, principles and theories, including bioethics and legal principles.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Good Manufacturing Practice (GMP) [4.0 RAC]
4.0 RAC Credits
Member: $465.00 Nonmember: $640.00
This course provides a basic understanding of current Good Manufacturing Practice (CGMP) regulations and their impact on product quality and patient safety.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Good Clinical Practice (GCP) [2.0 RAC]
2.0 RAC Credits
Member: $255.00 Nonmember: $350.00
This course identifies the regulations on the proper conduct of clinical research with human subjects that were put in place due to ethical issues in human research.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Good Laboratory Practice (GLP) [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course provides an overview of GLP regulations as they are applied and interpreted by the FDA, EPA and the Organization for Economic Cooperation and Development.
On-demand On-demand
IVDR 2022: What IVD manufacturers can learn from the MDR rollout
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will cover the potential impact of IVDR implementation in 2022 for new and existing (legacy) devices and considerations learned from the MDR rollout for IVD manufacturers to consider strategy.
On-demand On-demand
Update Your Medical Device UDI Data and Labels: This Year FDA Class I / Next Year EU MDR
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Join speakers from Reed Tech Life Sciences and NiceLabel for an interactive webcast focused on two compliance areas they are monitoring closely.

All Results

Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective

REMS and RMPs [3.0 RAC]

3.0RAC Credits
Member: $365 Nonmember: $500
This course provides an overview of the history of risk management, reviews risk management philosophies and examines regulatory requirements and interactions between industry and regulators in the US, EU and Canada
E-books E-books

Quality Management Systems for Drugs and Devices (e-book)

Member: $205.00 Nonmember: $285.00
Quality Management Systems for Drugs and Devices presents a comprehensive overview of quality management systems, including quality assurance, GMP, GLP, GCP, and compliance.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective

Supplier Management [3.0 RAC]

6.0RAC Credits
Member: $365.00 Nonmember: $500.00
This course provides a basic understanding of current supplier management practices and their impact on product quality and patient safety.
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.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective

Medical Devices: Risk Management [4.0 RAC]

4.0RAC Credits
Member: $465.00 Nonmember: $640.00
This course is intended for professionals of all experience levels interested in the techniques of risk management as applied to product safety for medical devices.