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RoundupsRoundups
Asia-Pacific Roundup: Pakistan’s DRAP issues draft guidelines for good cold chain management
Posted 28 March 2023 By Nick Paul Taylor
DRAP has based the draft guideline on the World Health Organization (WHO) Annex 9 Model guidance for storing and transporting time- and temperature–sensitive pharmaceutical products. The draft uses the same structure as the model guida...
Regulatory NewsRegulatory News
Pharma official: Expect “substantial” revision of ICH stability and specification guidelines
Posted 27 March 2023 By Joanne S. Eglovitch
BASEL, Switzerland – Two upcoming International Council on Harmonization (ICH) guidelines covering stability testing and specification setting are undergoing long-overdue revisions and are expected to be “substantially” revised and, an i...
Regulatory NewsRegulatory News
FDA eases labeling, clarifies IVD requirements in COVID transition guidances
Posted 27 March 2023 By Ferdous Al-Faruque
The US Food and Drug Administration (FDA) has made several changes to its guidances for transitioning medical devices and diagnostics from COVID-related authorization to traditionally marketed products – but it hasn’t budged on the 180-d...
RoundupsRoundups
Latin America Roundup: Colombia’s top regulator quits after 6 months; was key champion of multi-country agency
Posted 27 March 2023 By Jennie Smith
Rossi’s departure comes amid heated legislative debates about ongoing medication shortages in the country and the role of the regulatory agency in addressing them. Rossi had been a top proponent, along with his counterparts in Cuba and M...
ReconRecon
Recon: FDA to convene adcomm for twice-rejected ALS cell therapy; EU delays pharma legislation for third time
Posted 27 March 2023 By Joanne S. Eglovitch
Pharming’s Leniolisib Gains FDA Approval in Ultra-Rare Disease  California’s Plan for Cheaper Insulin Collides with Big Pharma’s Price Cuts  European Commission Steps In To Address Drug Trial Delays Due To IVD Regulation  Production...
Regulatory NewsRegulatory News
FDA encourages RCTs in accelerated approval guidance for oncology
Posted 27 March 2023 By Mary Ellen Schneider
“This ‘one-trial’ approach maintains efficiency in drug development and can provide early access to a drug using the accelerated approval pathway, while ensuring that a postmarketing trial is fully accrued and well underway to verify lon...
Regulatory NewsRegulatory News
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...

Event Calendar

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.
In-PersonIn-Person
Survivor: The FDA 510(k) Program Edition (April 2023)
Thursday, 20 April 2023 (9:00 - 4:00PM) 12.0 RAC Credits Price: Member $1340| Nonmember $1570
2-day, in-person workshop, regulatory experts to review the current requirements & expectations of this evolving program and provide strategies to help ensure success when navigating the FDA 510(k) program
     
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Books   |   Learning

BooksBooks
Regulatory Writing: An Overview, Second Edition
Member: $160.00 Nonmember: $225.00
This new edition is a valuable resource for professionals engaged in designing, composing, compiling, or commenting on regulatory documentation.
On-demandOn-demand
Regulatory Policy & Intelligence: Understanding When, Why, and How to Invest in Growing These Capabilities (On-Demand)
1.0 RAC Credits
Member: $0 Nonmember: $25
Industry-leading regulatory experts will provide practical insights on how to assess RI needs, why this area is worth the investment, and how to build an RI strategy that fortifies the unique objectives of your company.
On-demandOn-demand
Stay on Track and Get Some Sleep: Marketing Application Best Practices (On-Demand)
1.0 RAC Credits
Member: $0.00 Nonmember: $25.00
Regulatory experts will offer tips and guidance for acceleration, submission leadership, and regulatory strategy from that you can apply to your marketing application to help ensure a successful submission.
BooksBooks
Global Medical Device Regulatory Strategy, Second Edition
Member: $205.00 Nonmember: $285.00
Learn to develop a comprehensive global regulatory strategy for medical devices, labeling, clinical, risk management, marketing, and postmarketing.
On-demandOn-demand
Effective Labeling Management Requires a New Mindset : A Strategic Guide to Labeling Process Optimization (On-Demand)
1.0 RAC Credits
Member: $0.00 Nonmember: $25.00
This webcast will review the best methods to evaluate factors that could affect product labeling management.
On-demandOn-demand
Strategies for Successful PMCF Planning and Execution (On-Demand)
1.0 RAC Credits
Member: $0.00 Nonmember: $25.00
Walks you through a clear process for ensuring your PMCF planning is effective and efficient, beginning with an overview of what's required and how to evaluate your current state against the requirements.
On-demandOn-demand
Achieving Medical Device Development Success Through Early Implementation of Regulatory, Reimbursement and Clinical Research Strategies (On-Demand)
1.0 RAC Credits
Member: $0.00 Nonmember: $25.00
Learn best practices and proven strategies to address challenges presented by today’s shifting regulatory environment and the keys to commercial success.
BooksBooks
The European In Vitro Diagnostic Regulation
Member: $295.00 Nonmember: $395.00
RAPS has teamed up with Meddev Solutions to offer a practical guide to implementing the EU IVDR.
BooksBooks
Introduction to the Due Diligence Process, Second Edition
Member: $75.00 Nonmember: $125.00
Explore modern elements of the due diligence process, including the changing focus of document review, and the role of regulatory counsel.
On-demandOn-demand
How to Integrate Risk Management Throughout the Lifecycle of a Medical Device in the Coming Decade (On-Demand)
1.0 RAC Credits
Member: $0.00 Nonmember: $25.00
This webcast will review the application of a modern approach to risk management as a product moves through the product lifecycle.
BooksBooks
Fundamentals of EU Regulatory Affairs, Ninth Edition
Members: $147.50 Nonmembers: $197.50
Learn about the transformation of the EU healthcare product regulatory landscape, including the impact of Brexit and EMA’s move from London to Amsterdam.
On-demandOn-demand
Are You Ready to Begin Planning your IND Submission? (On-Demand)
1.0 RAC Credits
Member: $0.00 Nonmember: $25.00
Regulatory experts will offer advice pertaining to selecting a target indication, seeking pre-IND advice from FDA, deciding whether to use US or non-US sites for early clinical research, and more.
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.
Virtual ProgramsVirtual Programs
RAPS eCornell Regulatory Leadership Certificate Program
Wednesday, 01 November 2023 (8:00 - 5:00PM)
12.0RAC Credits
Member: $4250 | Nonmember: $5250 | Enterprise: $4250
RAPS has partnered with eCornell, to bring you a specialized certificate program to help perfect and validate your Diversity, Equity, and Inclusion (DEI) leadership skills
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.