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This Week at FDA: Becerra asks for new authorities; FDA issues guidances, reports
Posted 24 March 2023 By 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. It’s been a busy week for the agency as Xavier B...
Regulatory NewsRegulatory News
FDA outlines plan for digital health technologies for clinical trials
Posted 24 March 2023 By Ferdous Al-Faruque
The US Food and Drug Administration (FDA) plans to hold at least one public meeting and release several guidances on digital health technologies (DHT) to be used in drug clinical trials by the end of the year. While it has issued guidanc...
Regulatory NewsRegulatory News
EMA official shares lessons learned from the COVID pandemic
Posted 24 March 2023 By Joanne S. Eglovitch
One process that worked: For promising COVID treatments, EMA was able to provide enhanced presubmission dialogue with sponsors. EMA also was able to conduct “agile” assessments for promising treatments and ensure safety monitoring for th...
Regulatory NewsRegulatory News
Decentralized trials getting some attention on the international regulatory front
Posted 24 March 2023 By Joanne S. Eglovitch
At the meeting, a panel of EMA officials, representatives of patient groups, and pharmaceutical industry representatives discussed some of the current challenges in conducting decentralized clinical trials in the EU, where differences am...
Regulatory NewsRegulatory News
Becerra asks for supply chain monitoring authorities, incentives for antimicrobial drugs
Posted 23 March 2023 By Ferdous Al-Faruque
The head of the US Department of Health and Human Services (HHS) is asking lawmakers for additional authorities to track product supply chains to avoid shortages and the need to give incentives to antimicrobial drug manufacturers to deve...
Regulatory NewsRegulatory News
DARWIN EU ‘ramping up quickly’ with more partners coming on board
Posted 23 March 2023 By Joanne S. Eglovitch
“Many people initially who told us they were skeptical of its value understood that when you wanted to evaluate the safety or the effectiveness of the vaccine in everyday rollouts, it was RWE that was answering the critical questions.  A...
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...

Event Calendar

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.
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.
     
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Books   |   Learning

On-demandOn-demand
Leveraging Technology to Drive Strategic Impact
1.0 RAC Credits
Member: $0 | NonMember: $25
Join a dynamic discussion with regulatory affairs leaders from pharma and biotech on leveraging technology to drive strategic impact. Hear first-hand how these leaders are making a difference.
Online CourseOnline Course
Regulatory Writing: Building a Successful Culture for Collaborative Writing
2.0 RAC Credits
Member: $255.00 Nonmember: $350.00
This course explores the barriers to effective teamwork on interdisciplinary teams, along with identifying strategies for timely, relevant, and understandable communication.
Online CourseOnline Course
How to Conduct a Regulatory Pathway Assessment Series: FDA 101 Navigating the FDA for the first time
1.0 RAC Credits
Member: $150.00 Nonmember: $200.00
This first course introduces FDA risk-based device classifications, FDA product codes, regulatory controls and the five steps to market for a new medical device.
On-demandOn-demand
RAPS Webcast: Optimizing Standards for Regulatory Use (On-Demand)
1.0 RAC Credits
Price: $0 Member | $25 NonMember
This webcast will feature an FDA presentation on how consensus standards can be improved in order to better allow manufacturers to cite them appropriately in device submissions.
On-demandOn-demand
Sponsored Webcast: Minimizing Medication Errors: Designing Safe Container and Carton Labeling (On-Demand)
1.0 RAC Credits
Price: $0 Member | $25 NonMember
In this webcast, experts from Med Safety Board, a subsidiary of the Institute for Safe Medication Practices, will review the significant changes that were incorporated into the finalized FDA guidance.
On-demandOn-demand
Sponsored Webcast: How Drug Developers Can Navigate the Inflation Reduction Act (On-Demand)
1.0 RAC Credits
Member: $0 | NonMember: $25
This webcast provides a thorough explanation of the Inflation Reduction Act. By attending, regulatory professionals and manufacturers can better comply with the new regulations.
On-demandOn-demand
Meet the Author: Risk Management Principles for Devices and Pharmaceuticals, Third Edition (On-Demand)
Member: $0 | NonMember: $25
This book aims to document the rules and regulations regarding peri- and post-marketing risk management principles and practices.
On-demandOn-demand
RAPS Webcast: MDR by The Numbers (On-Demand)
1.5 RAC Credits
Member: $0 | NonMember: $25
MDR implementation cold, hard, numbers: results of research on recent MDCG guidance, industry and Notified Body surveys, and interviews with stakeholders (including NB) on experiences with implementation.
On-demandOn-demand
Insights and Actions from the 2023 Medtech Regulatory Performance Report Event (On-Demand)
1.0 RAC Credits
Price: $0 Member | $25 NonMember
The 2022 Medtech Regulatory Performance survey of 200 medtech regulatory professionals yielded some expected and some unexpected results. We will explore the findings and regulatory predictions for 2023.
On-demandOn-demand
RAPS Webcast: Streamlining Conformity Assessment in Device Submissions: FDA’s ASCA Program (On-Demand)
1.0 RAC Credits
Member: $0 | NonMember: $25
Introductory webcast for participants to the webcast for participants to the FDA's ASCA, a program in which manufacture.rs may contract with ASCA-accredited test labs to perform testing to certain consensus standards
BooksBooks
Risk Management Principles for Devices and Pharmaceuticals, Third Edition
Member: $150.00 Nonmember: $200.00
This book aims to document the rules and regulations regarding peri- and postmarketing risk management principles and practices.
On-demandOn-demand
2022 NMPA (CFDA) Key Updates and Look Ahead (On-Demand)
1.0 RAC Credits
Member: $0 | NonMember: $25
In this webcast, key policies, guidelines, and standards will be reviewed. Manufacturers and Inventors can implement techniques to shorten their time to market.
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
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
Chapter EventsChapter Events
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.
Virtual ProgramsVirtual Programs
Preparing to Take the RAC Drugs Exam (May 2023)
Wednesday, 31 May 2023 (11:00 - 4:00PM)
12.0RAC Credits
Member: $495 | NonMember: $580
Designed specifically for those preparing to take the RAC Drugs exam. This workshop will be facilitated by a panel of RAC-certified regulatory professionals and focuses on sharpening strategic test-taking skills.