Regulatory NewsRegulatory News
ICH adopts S12 guideline for gene therapies
Posted 20 March 2023 By Michael Mezher
The International Council for Harmonisation (ICH) last week announced that its S12 guideline on nonclinical biodistribution (BD) considerations for gene therapy products has reached Step 4 of the ICH process, meaning it’s ready for regul...
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 MezherFerdous 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While the US Food and Drug Administration’s (FDA) latest draft guidance on improving the consistency of information in the dosage and administration section of prescription drug labeling is significantly larger than an earlier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...
Regulatory NewsRegulatory News
FDA finalizes guidance on suspect products under DSCSA
Posted 16 March 2023 By Joanne S. Eglovitch
The US Food and Administrations (FDA) on Thursday finalized guidance defining what constitutes suspect and illegitimate products, as well as what constitutes products that are counterfeit, diverted, stolen, fraudulent or unfit for distri...
Regulatory NewsRegulatory News
FDA warns three US OTC drugmakers for lax component testing, missing validation programs
Posted 16 March 2023 By Joanne S. Eglovitch
Three domestic drug manufacturers were chastised in recent warning letters sent by the US Food and Drug Administration (FDA) for similar good manufacturing practice (GMP) violations related to failure to test incoming components and miss...
Regulatory NewsRegulatory News
FDA issues guidance on developing long-acting local anesthetics
Posted 16 March 2023 By Mary Ellen Schneider
The US Food and Drug Administration (FDA) has issued draft guidance on the development of local anesthetic products with a prolonged duration of effect that can last for days.
RoundupsRoundups
Euro Roundup: Commission delays notified body reassessments to free up capacity for MDR, IVDR
Posted 16 March 2023 By Nick Paul Taylor
The European Commission has published delegated regulations to change the frequency that notified bodies are reassessed under the new device and diagnostic regulations.
ReconRecon
Recon: Pfizer recalls migraine drug over packaging issues; UK lobby group suspends Novo Nordisk after rule violation
Posted 16 March 2023 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
Pharma wants FDA’s IND reporting rule better aligned with ICH E2F
Posted 15 March 2023 By Joanne S. Eglovitch
Pharmaceutical industry stakeholders urged the US Food and Drug Administration (FDA) to better align its investigational new drug application (IND) annual reporting proposal with the International Council’s for Harmonization’s (ICH) E2F...
Regulatory NewsRegulatory News
FDA revises guidance on electronic systems and signatures in clinical trials
Posted 15 March 2023 By Ferdous Al-Faruque
The US Food and Drug Administration (FDA) on Wednesday revised its draft guidance on electronic systems, records and signatures in clinical trials. While the new guidance continues to use the questions and answers format of the previous ...
Regulatory NewsRegulatory News
FDA warns pharmacy benefit company for distributing unapproved foreign drugs
Posted 14 March 2023 By Ferdous Al-Faruque
The US Food and Drug Administration (FDA) recently warned pharmacy benefit firm ElectRx for substituting prescription drugs ordered by its customers with drugs sourced from foreign pharmacies that have not been approved by the agency.
In-PersonIn-Person
Chapter EventsChapter Events
Virtual ProgramsVirtual Programs
Twin Cities Chapter Hybrid Event: The eSTAR and I: Getting to Know the eSTAR Templates for FDA Submissions
Tuesday, 21 March 2023 (6:00 - 7:30PM) 1.0 RAC Credits Price: Free
This hybrid in-person / virtual event will provide insights to the structure of the FDA eSTARsubmission templates for 510(k) and De Novo submissions as well as tactics to optimize submissionquality and success.
Virtual ProgramsVirtual Programs
Introduction to eCTD: Structuring your first CTD based submission (March 2023)
Wednesday, 22 March 2023 (10:00 - 5:00PM) 12.0 RAC Credits Member: $970 | NonMember: $1150
Join RAPS for a two-day workshop on regulatory submissions in eCTD format, discussing both the underlying CTD structure and their options for implementing operational changes for electronic applications.
Virtual ProgramsVirtual Programs
Sponsored Webcast: Leveraging Technology to Drive Strategic Impact
Wednesday, 22 March 2023 (11:00 - 12:00PM) 1.0 RAC Credits Price: Free
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.
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.
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.
     
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Books   |   Learning

RAC Prep BundleRAC Prep Bundle
RAC (Devices) Reference Package: Complete Bundle
Member: $1,900 Nonmember: $2,600
Referred to as 'Reference Packages', RAC Prep bundles combine several of RAPS individual RAC prep tools together at a discounted rate.
RAC Prep BundleRAC Prep Bundle
RAC (Drugs) Reference Package: Complete Bundle
Member: $1,900 Nonmember: $2,600
Referred to as 'Reference Packages', RAC Prep bundles combine several of RAPS individual RAC prep tools together at a discounted rate.
Product BundleProduct Bundle
Clinical Trial Foundations Bundle
Member: $575.00 Nonmember: $790.00
Improve your knowledge surrounding the proper conduct of clinical research with human subjects.
Product BundleProduct Bundle
GxP Bundle
Member: $865.00 Nonmember: $1,292.00
This three-course series examines essential topics within a quality system—Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP).
Product BundleProduct Bundle
Regulatory Medical Writing Bundle [Complete Package]
Member: $1,240.00 Nonmember: $1,710.00
Learn more about the components of various application types and techniques for improving document quality.
Product BundleProduct Bundle
Regulatory Medical Writing Bundle [Package #1]
Member: $1,050.00 Nonmember: $1,440.00
Learn more about the components of various application types and techniques for improving document quality.
Product BundleProduct Bundle
Regulatory Basics Bundle - Complete
Member: $500.00 Nonmember: $700.00
This bundle provides fundamental information on product lifecycles, gives insight into professional roles and responsibilities and discusses regulatory mechanisms, processes and agencies within key markets.
Product BundleProduct Bundle
Regulatory Basics Bundle - US & Canada
Member: $400.00 Nonmember: $560.00
This bundle provides fundamental information on product lifecycles, gives insight into professional roles and responsibilities and discusses regulatory mechanisms, processes and agencies within key markets.
BooksBooks
The Medical Device Validation Handbook, Second Edition
Member: $205.00 Nonmember: $285.00
The handbook covers device validation and revalidation throughout the product lifecycle, from design through postmarket.
BooksBooks
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.
On-demandOn-demand
How to Better Manage Quality and Risk with a Global Change Control Strategy (On-Demand)
1.5 RAC Credits
Member: $0.00 Nonmember: $25.00
Learn about the contributing factors to building change control system that can help manage risk as well as metrics to consider to drive success.
On-demandOn-demand
How to Effectively Talk to Regulators (On-Demand)
1.5 RAC Credits
Member: $0.00 Nonmember: $25.00
Learn the dos and don’ts of communicating with a regulator, including examples of industry effectively working with FDA.
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.
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
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.
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.