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RoundupsRoundups
Euro Roundup: MHRA advances major overhaul of UK clinical trial regulation after positive feedback
Posted 23 March 2023 By Nick Paul Taylor
The UK will combine MHRA and ethics reviews and aim to complete assessments within 30 days of the validation of the application. Combining the reviews halved the review time, and reduced the time from application to first patient in, dur...
Feature ArticlesFeature Articles
RF Quarterly, March 2023: Patient-focused regulatory practice
Posted 22 March 2023 By Flora Sandra Siami, MPH • Stephen C. Weber, MD
Welcome to the March issue of RF Quarterly, which examines patient-focused regulatory practice and includes articles on patient-reported outcomes in regulatory decision making; real-world evidence and postmarket surveillance data; genera...
The evolution and use of patient-reported outcomes in regulatory decision making
Posted 22 March 2023 By Stephen C. Weber, MD
Patient-reported outcome measures (PROMs) have been increasingly mandated to measure the success of clinical outcomes in regulatory decision making. However, these outcome measures require expertise in their application and interpretatio...
Real-world evidence and postmarket surveillance data: Are they the same thing?
This article compares real-world evidence (RWE) and postmarket surveillance (PMS) data collected outside of a randomized, controlled, clinical trial. Real-world data (RWD) include individual patient data points such as complaints and ane...
Generating evidence for racial and ethnic minorities during development of oncologic therapeutics
Discussions regarding diversity, equity, and inclusion in healthcare and clinical research have been ongoing for decades. However, the COVID-19 global pandemic brought about a new focus on this issue. As the pharmaceutical industry began...
Industry implementation of structured, patient-focused benefit-risk assessment
Posted 22 March 2023 By Charles Garrigan, MS, MBA • Bennett Levitan, MD, PhD
Benefit-risk (BR) assessment, a central part of regulatory decision making, has become increasingly structured in response to the need for consistency and transparency, and in alignment with the US Food and Drug Administration’s (FDA’s) ...
Enhancing collaboration, access, and research using patient-generated data
Posted 22 March 2023 By Laura E. Gressler, MS, PhD • Art Sedrakyan, MD, PhD
Patient-provided information (PPI) and patient-generated health data (PGHD) are critical sources of real-world data and evidence. Collecting this data empowers patients to become partners in informed decision making by all healthcare sta...
RoundupsRoundups
Asia-Pacific Roundup: Japan revises postmarket safety controls ahead of launch of generic lenalidomide
Posted 21 March 2023 By Nick Paul Taylor
The dispensing of lenalidomide Japan is covered by the RevMate control procedures because the drug molecule has a similar chemical structure to thalidomide and was shown to cause birth defects and abnormalities in animal studies.
Regulatory NewsRegulatory News
FDA’s top cybersecurity officials discuss heightened threats, technology modernization
Posted 20 March 2023 By Ferdous Al-Faruque
In a nondescript building in North Bethesda, Maryland, the US Food and Drug Administration (FDA) houses a cybersecurity control center responsible for protecting its digital assets. Since the beginning of the COVID-19 pandemic, the agenc...
ReconRecon
Recon: FDA staff say safety issues for Biogen’s ALS drug don’t preclude approval; BioNTech partners with OncoC4 to develop immunotherapy drug
Posted 20 March 2023 By Michael Mezher
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
This Week at FDAThis Week at FDA
This Week at FDA: FDA’s budget justification, Nurtec ODT recall, and more
Posted 17 March 2023 By Michael Mezher • Ferdous Al-Faruque
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, FDA released more details on its FY20...
Regulatory NewsRegulatory News
Industry requests more information from FDA on dosage and administration labeling
Posted 17 March 2023 By Jeff Craven
While the US Food and Drug Administration’s (FDA) latest draft guidance on improving the consistency of information in the dosage and administration section of prescription drug labeling is significantly larger than an earlier guidance i...

Event Calendar

Virtual ProgramsVirtual Programs
Practical Application of ISO14971: 2019 Risk Management for Medical Devices
Thursday, 04 May 2023 (12:00 - 1:30PM) 1.5 RAC Credits Member: $175 | NonMember: $200
This webinar will provide practical advice on building or remediating a medical device risk management system that complies with ISO14971:2019, and supports compliance with other medical device regulations
Introduction to ISO 13485
Thursday, 10 August 2023 (9:00 - 1:00PM) 3.0 RAC Credits Member: $335 | NonMember: $395
This half-day introduction will provide you with an understanding of the purpose of a Quality Management System (QMS) and the key principles of ISO 13485:2016.
In-PersonIn-Person
Executive Development Program at the Kellogg School of Management (May 2023)
Sunday, 07 May 2023 (9:00 - 4:00PM) 12.0 RAC Credits The only leadership program dedicated to regulatory professionals like you that combines regulatory experts with faculty from one of the most prestigious business schools in the US, the Kellogg School of Management at Northwestern University.
Virtual ProgramsVirtual Programs
Clinical Evaluation for Medical Devices
Monday, 12 June 2023 (9:00 - 1:00PM) 12.0 RAC Credits Price: Member: $1125 NonMember: $1290
This training will give you the skills to ensure all the requirements of the EU MDR are met & provide insight into how clinical evaluation is integrated with risk management and post-market surveillance.
In-PersonIn-Person
Chapter EventsChapter Events
Twin Cities Chapter Workshop: REG 101, Medical Devices
Monday, 17 April 2023 (8:00 - 5:00PM) 6.0 RAC Credits Member $75 | Nonmember $175 | Student $50
The workshop conducted by respected medical device field experts, provides a comprehensive overview of medical device regulations and provides critical knowledge for bringing medical devices to market.
Virtual ProgramsVirtual Programs
Overcoming the Regulatory Challenges of Oligonucleotide Therapy CMC
Tuesday, 16 May 2023 (8:00 - 12:00PM) 3.0 RAC Credits Member: $335 | NonMember: $395 This workshop provides an understanding for developing an oligonucleotide CMC regulatory strategy. By attending, regulatory & quality professionals will leverage sound CMC submission drafting approaches.
Chapter EventsChapter Events
Virtual ProgramsVirtual Programs
San Francisco Chapter Event: Clinical Trial Data Privacy and Protection- Fundamentals
Tuesday, 04 April 2023 (12:00 - 1:00PM) 1.0 RAC Credits Price: Member Free | Nonmember $25
This 45 minute session followed by Q&A is will inform the audience of the latest in data regulations and the potential of those regulations to impact clinical trial planning, operations and data reporting.
Virtual ProgramsVirtual Programs
Chapter EventsChapter Events
San Francisco Bay Area Chapter: Things to Know About IEC 60601-1 Amendment 2
Friday, 24 March 2023 (12:00 - 1:15PM) 1.0 RAC Credits Member: Free | NonMember: $25
The IEC published amendment 2 to 60601-1 in August 2020. This webcast will cover changes, possible areas of concern, which collaterals have undergone major changes, and key points for 62368-1 devices.
In-PersonIn-Person
Risk Management for the Full Product Life Cycle: Design Concept through Post-Market Surveillance
Tuesday, 18 April 2023 (8:00 - 5:00PM) 12.0 RAC Credits Member: $1340 | Nonmmember: $1570
The session demonstrates an approach to sustain and use a Risk Management File throughout the product life. By attending, manufacturers will be better positioned to meet the latest regulatory requirements.
In-PersonIn-Person
Biologics CMC: Phase Appropriate Product Development (April 2023)
Thursday, 27 April 2023 (9:00 - 4:00PM) 12.0 RAC Credits Member: $1340 | NonMember: $1570
Learn how to handle technical issues affecting biologic product development challenges and expectations in the US, Europe, and other highly regulated regions.
Virtual ProgramsVirtual Programs
Sponsored Webcast: Oops, I Messed Up! How to Avoid (and Fix) Common Regulatory Submission Mistakes
Wednesday, 19 April 2023 (11:00 - 12:00PM) 1.0 RAC Credits Free
This webcast will provide understanding of common mistakes, errors, and omissions in regulatory submissions with insight to avoid or solve them.
Virtual ProgramsVirtual Programs
US Regulatory Essentials, Devices (April 2023)
Tuesday, 04 April 2023 (10:00 - 3:30PM) 12.0 RAC Credits Members: $970| Nonmembers: $1150
This online workshop offers a comprehensive overview of U.S. regulatory affairs for medical devices and IVDs.
     
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Books   |   Learning

E-booksE-books
Postmarket Requirements for Medical Devices: A Practical Guide (e-book)
Member: $175 Nonmember: $245
Comprehensive guide covering product change evaluation, postmarket surveillance, and compliance with audit/inspection requirements in the medical device industry.
On-demandOn-demand
Sponsored Webcast: A Regulatory and Strategic Framework for Facilitating Pediatric Drug Development (On-Demand)
1.0 RAC Credits
Member: $0 | Nonmember: $25
During the webinar, pediatric development experts will provide an overview of the global regulatory framework and requirements that drive pediatric development.
On-demandOn-demand
Meet the Authors, Regulatory Writing, Second Edition (On-Demand)
1.0 RAC Credits
Price: $0 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.
BooksBooks
Fundamentals of Medical Device Regulations, Fifth Edition
Member: $295.00 Nonmember: $395.00
A current view of regulations governing medical devices and IVDs, and covers the entire medical device lifecycle, from product development through postmarketing.
On-demandOn-demand
Impact of MDR on Drug-Device Combination Products: Notified Body Opinion and CE Mark Applications (On-Demand)
6.0 RAC Credits
Member: $480 Non-Member: $540
Learn how EU MDR 2017/745 affects integral drug-device combinations and how to develop a complete dossier for Notified Body review.
On-demandOn-demand
Best Practices for Regulatory Compliant Literature Review (On-Demand)
1.0 RAC Credits
Member: $0.00 Nonmember: $25.00
You will gain an understanding of practical considerations to help you conduct a high-quality literature review to produce quality data output for your CERs.
On-demandOn-demand
AI for Post Market Surveillance Compliance and Regulatory Work According to MDR (On-Demand)
1.5 RAC Credits
Member: $0.00 Nonmember: $25.00
Webcast registration includes access to handouts, presentation slides and the on-demand recording for one year.
On-demandOn-demand
How to Facilitate Regulatory Meetings (On-Demand)
1.5 RAC Credits
Member: $0.00 Nonmember: $25.00
This webcast will help prepare regulatory professionals for the difficult task of meeting facilitation.
RAC ExamRAC Exam
RAC Devices Examination Autumn 2023
Member: $495.00 Nonmember: $625.00
Testing Window :
30 October 2023 To 8 December 2023
Registration Deadline : 5 October 2023
RAC ExamRAC Exam
RAC Devices Examination Summer 2023
Member: $495.00 Nonmember: $625.00
Testing Window : 10 July 2023 To 18 August 2023
Registration Deadline : 15 June 2023
RAC ExamRAC Exam
RAC Drugs Examination Autumn 2023
Member: $495.00 Nonmember: $625.00
Testing Window :
30 October 2023 To 8 December 2023
Registration Deadline : 5 October 2023
RAC ExamRAC Exam
RAC Drugs Examination Summer 2023
Member: $495.00 Nonmember: $625.00
Testing Window : 10 July 2023 To 18 August 2023
Registration Deadline : 15 June 2023
In-PersonIn-Person
RAPS Convergence 2023
Tuesday, 03 October 2023 (8:00 - 4:00PM)
12.0RAC Credits
Meet global regulators, industry experts, solution providers, and more in Montreal, QC 3-5 October for three days of professional development, discussion, and relationship building.
Introduction to ISO 13485
Thursday, 10 August 2023 (9:00 - 1:00PM)
3.0RAC Credits
Member: $335 | NonMember: $395
This half-day introduction will provide you with an understanding of the purpose of a Quality Management System (QMS) and the key principles of ISO 13485:2016.
In-PersonIn-Person
Intermediate eCTD: Solutions to Make the Publishing Rules Work for You
Tuesday, 27 June 2023 (9:00 - 4:00PM)
12.0RAC Credits
Member: $1340 | Nonmember: $1570
This hands-on publishing workshop will help you incorporate your working knowledge of the ICH CTD structure into eCTD submission planning, compilation and publishing.
In-PersonIn-Person
Root Cause Investigation for CAPA (June 2023)
Wednesday, 21 June 2023 (9:00 - 5:00PM)
12.0RAC Credits
Member: $1340 | Nonmember: $1570
Root Cause Investigation for CAPA is a globally renown methodology for investigating technical performance challenges, particularly in highly regulated industries.
In-PersonIn-Person
Regulatory Strategies & Advice for MedTech Start-up Companies
Tuesday, 20 June 2023 (9:00 - 5:00PM)
6.0RAC Credits
Price: $785 Member | $920 Nonmember
This program will focus on regulatory strategies & pitfalls by considering time-to market & risk aspects. By attending, the RA professional will be able to implement the right strategy in his company.
Virtual ProgramsVirtual Programs
Software as a Medical Device (SaMD) (June 2023)
Wednesday, 14 June 2023 (9:00 - 4:00PM)
12.0RAC Credits
Member $970 | Non-Member $1150
Join us for a review of the current and evolving global regulatory requirements affecting software as a medical device (SaMD).
Virtual ProgramsVirtual Programs
Clinical Evaluation for Medical Devices
Monday, 12 June 2023 (9:00 - 1:00PM)
12.0RAC Credits
Price: Member: $1125 NonMember: $1290
This training will give you the skills to ensure all the requirements of the EU MDR are met & provide insight into how clinical evaluation is integrated with risk management and post-market surveillance.
Virtual ProgramsVirtual Programs
Preparing to Take the RAC Devices Exam (May 2023)
Monday, 22 May 2023 (5:00 - 8:00PM)
6.0RAC Credits
Members: $580|Nonmembers: $680
This workshopwill be facilitated by a panel of regulatory professionals who have earned their RAC credential and are subject matter experts in their field.
Virtual ProgramsVirtual Programs
Overcoming the Regulatory Challenges of Oligonucleotide Therapy CMC
Tuesday, 16 May 2023 (8:00 - 12:00PM)
3.0RAC Credits
Member: $335 | NonMember: $395 This workshop provides an understanding for developing an oligonucleotide CMC regulatory strategy. By attending, regulatory & quality professionals will leverage sound CMC submission drafting approaches.
Virtual ProgramsVirtual Programs
Sponsored Webcast: Navigating the UK Drug Approval Landscape Post-Brexit
Thursday, 11 May 2023 (11:00 - 12:00PM)
1.0RAC Credits
Free
This webinar will provide an understanding of the current regulatory landscape in the UK.
Chapter EventsChapter Events
DC/ Baltimore Chapter Webcast: Conducting a Biocompatibility Risk Assessment for a Submission
Tuesday, 09 May 2023 (12:00 - 1:00PM)
1.0RAC Credits
Member: $0 | Nonmember: $25
This presentation will provide a practical approach to aid regulatory professionals drafting a biocompatibility risk assessment to use in preparing various regulatory submissions.
In-PersonIn-Person
Executive Development Program at the Kellogg School of Management (May 2023)
Sunday, 07 May 2023 (9:00 - 4:00PM)
12.0RAC Credits
The only leadership program dedicated to regulatory professionals like you that combines regulatory experts with faculty from one of the most prestigious business schools in the US, the Kellogg School of Management at Northwestern University.