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...
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While the US Food and Drug Administration’s (FDA) latest draft guidance on improving the consistency of information in the dosage and administration section of prescription drug labeling is significantly larger than an earlier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The US Food and Drug Administration (FDA) has issued draft guidance on the development of local anesthetic products with a prolonged duration of effect that can last for days.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.
Regulatory NewsRegulatory News
EMA-FDA parallel scientific advice program has ‘limited’ uptake
Posted 14 March 2023 By Mary Ellen Schneider
A review of the last five years of the Parallel Scientific Advice (PSA) program between the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) shows that the agencies received a total of 37 applications from sp...
PreviewPreview
Combination Products Summit 2023
Tuesday, 28 November 2023 (8:30 - 5:00PM) 0.0 RAC Credits 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
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
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
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.
In-PersonIn-Person
Regulatory Strategies & Advice for MedTech Start-up Companies
Tuesday, 20 June 2023 (9:00 - 5:00PM) 6.0 RAC 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
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
Introduction to eCTD: Structuring Your First CTD-based Submission (May 2023)
Monday, 08 May 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
RAPS Webcast: Rapid Sharing of International Clinical Data Ensuring Patient Privacy for Combating Pandemics and Other Diseases
Tuesday, 23 May 2023 (12:00 - 1:00PM) 1.0 RAC Credits Free
Health situations like the COVID-19 pandemic, are urging us to change in the long research procedures restricted by national regulations as information sharing is the key to rapid innovation in the era of Bi.
Virtual ProgramsVirtual Programs
Preparing to Take the RAC Devices Exam (May 2023)
Monday, 22 May 2023 (5:00 - 8:00PM) 6.0 RAC 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.
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.
In-PersonIn-Person
MedCon 2023
Monday, 24 April 2023 (9:30 - 4:00PM) 0.0 RAC Credits For 13+ years, MedCon has united the healthcare products industry to work for a better tomorrow for our patients. MedCon 2023 is hosted by the AFDO/RAPS Healthcare Products Collaborative and co-sponsored by Food and Drug Administration (FDA).
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.
     
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Books   |   Learning

Online CourseOnline Course
Pharmaceutical Certificate ElectivePharmaceutical Certificate Elective
Understanding and Managing the US Clinical Trial Process [4.0 RAC]
4.0 RAC Credits
Member: $465 Nonmember: $640
This course provides an overview of the foundation for clinical trials in the US including their historical evolution, ethical conduct and regulations and the responsibilities of parties involved in clinical research
On-demandOn-demand
China NMPA Clinical Evaluation and Trial Key Changes to Support Order 739 Webcast (On-Demand)
1.0 RAC Credits
Member: $0.00 Nonmember: $25.00
This webcast will explore the evolving regulations for China NMPA, reviewing regulations related to clinical evaluation, the main changes under Decree #739 in areas of clinical evaluation pathways.
BooksBooks
Key Regulatory Topics: eCTD
Member: $87.50 Nonmember: $112.50
eCTD guidance documents from the ICH, EMA, and FDA.
Online CourseOnline Course
Pharmaceutical Certificate ElectivePharmaceutical Certificate Elective
Regulation of Generic Drugs in the US [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course provides a basic understanding of the legal and regulatory structure of generic drugs in the US.
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
On-demandOn-demand
Sponsored Webcast: What is FDA's Project Optimus and How Will it Impact Oncology Drug Development? (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $25
This webinar will provide information on FDA’s Project Optimus and its potential impacts on oncology drug development.
On-demandOn-demand
A Risk-Based Approach to Validation for Life Sciences Companies (On-Demand)
1.0 RAC Credits
Member: $0.00 Nonmember: $25.00
Learn how a risk-based validation approach can meet compliance requirements and maintain quality while streamlining the validation process.
Online CourseOnline Course
Single CertificateSingle Certificate
Regulatory Affairs Certificate: Pharmaceuticals
Member: $2380.00 Nonmember: $2980.00
The Regulatory Affairs Certificate: Pharmaceuticals is achieved by completing four core and five elective courses.
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
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
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.
On-demandOn-demand
FDA Forecast: What’s Next for the FDA in 2022? (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $25
In this webcast, AgencyIQ’s regulatory intelligence team will explore the top regulatory issues and challengers they expect the FDA and life sciences industry to encounter next year.
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
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
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.
Virtual ProgramsVirtual Programs
RAPS Webcast: Rapid Sharing of International Clinical Data Ensuring Patient Privacy for Combating Pandemics and Other Diseases
Tuesday, 23 May 2023 (12:00 - 1:00PM)
1.0RAC Credits
Free
Health situations like the COVID-19 pandemic, are urging us to change in the long research procedures restricted by national regulations as information sharing is the key to rapid innovation in the era of Bi.
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.