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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...
ReconRecon
Recon: Moderna sets COVID vax price at $130/shot; Bancel defends decision at Senate hearing
Posted 23 March 2023 By Denise Fulton
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
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...
Regulatory NewsRegulatory News
Stakeholders offer input on educational materials for rare disease drug development
Posted 22 March 2023 By Jeff Craven
After the US Food and Drug Administration (FDA) solicited comments on an educational program for a new Empower Rare Disease Drug Developers (LEADER 3D) initiative in the Accelerating Rare disease Cures (ARC) program, nearly two dozen sta...
RAPS' LatestRAPS' Latest
How regulatory affairs connects science to patients
Posted 22 March 2023 By Ryan Connors
Eleanor Panico, director of regulatory affairs at Eisai, stops by for a chat about her career path and much more. 
Regulatory NewsRegulatory News
NCI official raises concerns about FDA’s cancer drug dose optimization guidance
Posted 21 March 2023 By Ferdous Al-Faruque
The head of the National Cancer Institute’s (NCI) investigational drug research branch said that recent draft guidance from the US Food and Administration (FDA) on finding the optimal dosage for cancer drugs could slow drug development. ...
Regulatory NewsRegulatory News
FDA issues guidance on submission of pharmacogenomic data
Posted 21 March 2023 By Mary Ellen Schneider
The US Food and Drug Administration (FDA) has issued draft guidance to clarify which pharmacogenomic study findings and data should be included in regulatory submissions for investigational new drug applications (INDs), new drug applicat...

Event Calendar

Virtual ProgramsVirtual Programs
The Evolving Regulatory Landscape in Oncological Drug Development
Thursday, 23 March 2023 (12:00 - 1:30PM) 1.5 RAC Credits Member: $175 | Nonmember: $200 This workshop will provide an overview of three recent initiatives from the Oncology Center of Excellence, as well as some in-depth discussions with several key opinion leaders.
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.
Virtual ProgramsVirtual Programs
Preparing for an FDA PAI or BIMO Inspection
Wednesday, 29 March 2023 (12:00 - 1:30PM) 1.5 RAC Credits Member: $175 | NonMember: $200
This workshop will provide a thorough understanding of how to prepare for an FDA PAI or BIMO inspection, including Inspection Readiness plans, Gap Analysis and Remediation, and Inspection Logistics.
Chapter EventsChapter Events
In-PersonIn-Person
Colorado Chapter Meet and Greet
Thursday, 30 March 2023 (5:00 - 7:30PM) 0.0 RAC Credits Price: Free
Connect with your Colorado regulatory affairs colleauges in the first in-person event of 2023 for theRAPS Colorado Chapter! Join us at Ratio Beerworks for a casual meet and greet.
In-PersonIn-Person
Chapter EventsChapter Events
Wisconsin In-person Chapter Event: Challenges and Lessons Learned from both an Industry and Notified Body Perspective for the Implementation of EU Regulations
Thursday, 30 March 2023 (6:00 - 8:30PM) 2.0 RAC Credits Price: Free
An overview of key learnings obtained on the journey to MDR and IVDR certification.
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.
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
China NMPA Regulations on IVD and Companion Diagnostics (April 2023)
Tuesday, 11 April 2023 (8:30 - 12:30PM) 12.0 RAC Credits Member: $970 NonMember: $1150
This workshop will focus on the latest NMPA regulations for In Vitro Diagnostics (IVD) products and companion diagnostics (CDx).
In-PersonIn-Person
Virtual ProgramsVirtual Programs
Chapter EventsChapter Events
San Francisco Bay Area Chapter Hybrid Event: Top 3 Mistakes to Avoid in your 510(k) Submission to the FDA or Third Party
Wednesday, 12 April 2023 (11:30 - 2:30PM) 2.0 RAC Credits Member: $35 | Non-Member: $45 | Student: $25
The FDA, SaMD & regulatory-strategy experts will offer insight into the top 3 510(k) submission mistakes at this hybrid virtual/in-person session at UCSC Silicon Valley satellite in Santa Clara, CA.
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.
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
Software as a Medical Device (April 2023)
Tuesday, 18 April 2023 (9:00 - 4:00PM) 12.0 RAC Credits Members: $1,340 | Nonmembers: $1,570
In this two-day, in-person workshop, regulatory experts will review current and evolving regulatory requirements for software as a medical device to navigate the challenging expectations for software.
     
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Books   |   Learning

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.
RAC Prep BundleRAC Prep Bundle
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.
RAC Prep BundleRAC Prep Bundle
RAC (Devices) Reference Package: Basic
Member: $400 Nonmember: $525
Purchase the Fundamentals of Medical Device Regulations book, RAC (Devices) Flashcards and Practice Test together and save on these indispensable reference tools—our most popular products to help you prepare.
BooksBooks
Essentials of Healthcare Product Labeling
Member: $130.00 Nonmember: $180.00
Learn details on labeling for the full lifecycle of human healthcare products, from target labeling through submission and marketing in the US, EU and Canada.
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
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.
BooksBooks
Fundamentals of Canadian Pharmaceutical, Biologic and Medical Devices Regulations
Member: $100.00 Nonmember: $150.00
A compilation of Fundamentals of Canadian Pharmaceutical and Biologics Regulations and Fundamentals of Canadian Medical Device Regulations.
RAC PrepRAC Prep
RAC (Drugs) Practice Test
Member: $85.00 Nonmember: $105.00
RAC Prep BundleRAC Prep Bundle
RAC (Devices) Prep Toolbox with Print Edition of Fundamentals of Medical Devices Regulations
Member: $1,500.00 Nonmember: $1,900.00
The Toolbox brings together a full range of valuable resources, gives you a sense for the kinds of questions you will be tested on and clarifies how the exam is structured.
RAC Prep BundleRAC Prep Bundle
RAC (Drugs) Prep Toolbox with Print Edition of Pharmaceutical and Biologics Fundamentals Book
Member: $1,500.00 Nonmember: $1,900.00
The Toolbox brings together a full range of valuable resources, gives you a sense for the kinds of questions you will be tested on and clarifies how the exam is structured.
RAC PrepRAC Prep
RAC (Devices) Practice Test
Member: $85.00 Nonmember: $105.00
RAC PrepRAC Prep
RAC (Devices) Prep Toolbox
Member: $1,250 ​Nonmember: $1,550
The Toolbox brings together a full range of valuable resources, gives you a sense for the kinds of questions you will be tested on and clarifies how the exam is structured.
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
PreviewPreview
Combination Products Summit 2023
Tuesday, 28 November 2023 (8:30 - 5:00PM)
The 2023 Combination Products Summit is hosted by the AFDO/RAPS Healthcare Products Collaborative and co-sponsored by Food and Drug Administration. The Combination Products Summit focuses on solutions for a dynamic industry with evolving regulations
PreviewPreview
Artificial Intelligence Summit
Tuesday, 14 November 2023 (8:30 - 5:00PM)
Since 2017, the AI Summit unites AI experts from industry, regulatory agencies & academia to understand challenges and actionable solutions in healthcare & life sciences. AI Summit 2023 is hosted by the AFDO/RAPS Healthcare Products Collaborative.
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.
Virtual ProgramsVirtual Programs
RAPS Webcast: Get Certified in Regulatory Affairs: Get Your RAC! (Sept 2023)
Friday, 08 September 2023 (1:00 - 2:00PM)
1.0RAC Credits
Price: Free
This webcast will answer top Regulatory Affairs Certification (RAC) questions. By attending, regulatory professionals will decide if earning a RAC is right for them and how to proceed.
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
NY/NJ Chapter Webcast: Regulatory Opportunities and challenges with mRNA Technology- Lessons Learned from the COVID-19 Pandemic
Monday, 12 June 2023 (12:00 - 1:30PM)
1.5RAC Credits
Member: $0 | NonMemeber $25
This webcast will describe the current regulatory framework applicable to mRNA products and explain the regulatory challenges and opportunities that have been enabled with mRNA technology.
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
Regulatory Challenges, Prospects, and Modern Solution
Thursday, 01 June 2023 (12:00 - 4:00PM)
3.0RAC Credits
Member: $335 | Nonmember: $395
We'll discuss the evolving regulatory landscape, opportunities, challenges, and the emerging use and analytics of real-world data (RWD), specifically, leveraging the innovation of Targeted Learning.