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While the US Food and Drug Administration’s (FDA) latest draft guidance on improving the consistency of information in the dosage and administration section of prescription drug labeling is significantly larger than an earlier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 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...
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.
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The US Food and Drug Administration (FDA) on Wednesday revised its draft guidance on electronic systems, records and signatures in clinical trials.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 ...
RAPS' LatestRAPS' Latest
Kristen Ortiz on life as a regulatory affairs manager, her trip to RAPS Convergence and more
Posted 14 March 2023 By Ryan Connors
Our member interview series continues in a chat with Kristen Ortiz, regulatory affairs manager at BD. 
This Week at FDAThis Week at FDA
This Week at FDA: FDA draws roadmap for pandemic era guidances
Posted 10 March 2023 By Michael MezherJoanne S. EglovitchFerdous 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 was a big news week for FDA watchers – we s...
Regulatory NewsRegulatory News
FDA seeks 10% boost in Biden’s FY 2024 budget
Posted 09 March 2023 By Ferdous Al-Faruque
The US Food and Drug Administration’s (FDA) is seeking to increase its budget authority by 10% in fiscal year 2024 as part of the Biden administration’s $6.9 trillion budget request. While the budget request also includes multiple legisl...
RoundupsRoundups
Euro Roundup: Advisory group urges UK to ‘rapidly explore’ recognition of US device approvals
Posted 09 March 2023 By Nick Paul Taylor
A group formed to advise the UK government on the regulation of medical devices is pushing for officials to “rapidly explore” building an equivalence route for approvals to include jurisdictions such as the US.
Regulatory NewsRegulatory News
FDA official warns manufacturers of common problems found in aseptic operations
Posted 07 March 2023 By Joanne S. Eglovitch
Sterile drug manufacturing is a high-risk operation and to manage these risks, drug manufacturers need to “tightly control” a multitude of variables to ensure processes remain in a state of control, asserted Brooke Higgins, a senior poli...
ReconRecon
Recon: FDA extends review of BioMarin's hemophilia gene therapy; Abbott's blood test for concussions cleared by FDA
Posted 07 March 2023 By Michael Mezher
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Virtual ProgramsVirtual Programs
Practical Application of ISO14971: 2019 Risk Management for Medical Devices
Thursday, 04 May 2023 (12:00 - 1:30PM) 1.5 RAC Credits Member: $175 | NonMember: $200
This webinar will provide practical advice on building or remediating a medical device risk management system that complies with ISO14971:2019, and supports compliance with other medical device regulations
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.
Virtual ProgramsVirtual Programs
Clinical Evaluation for Medical Devices
Monday, 12 June 2023 (9:00 - 1:00PM) 12.0 RAC 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.
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.
Virtual ProgramsVirtual Programs
Overcoming the Regulatory Challenges of Oligonucleotide Therapy CMC
Tuesday, 16 May 2023 (8:00 - 12:00PM) 3.0 RAC 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.
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.
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
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.
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
Biologics CMC: Phase Appropriate Product Development (April 2023)
Thursday, 27 April 2023 (9:00 - 4:00PM) 12.0 RAC Credits Member: $1340 | NonMember: $1570
Learn how to handle technical issues affecting biologic product development challenges and expectations in the US, Europe, and other highly regulated regions.
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.
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.
     
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Books   |   Learning

On-demandOn-demand
Sponsored Webcast: A Regulatory and Strategic Framework for Facilitating Pediatric Drug Development (On-Demand)
1.0 RAC Credits
Member: $0 | Nonmember: $25
During the webinar, pediatric development experts will provide an overview of the global regulatory framework and requirements that drive pediatric development.
On-demandOn-demand
Meet the Authors, Regulatory Writing, Second Edition (On-Demand)
1.0 RAC Credits
Price: $0 Hear from the experts who wrote the book on regulatory writing. Authors Lisa DeTora, Jocelyn Jennings and Jenny Grodberg will discuss the new edition’s writers-eye view of regulatory documentation.
BooksBooks
Fundamentals of Medical Device Regulations, Fifth Edition
Member: $295.00 Nonmember: $395.00
A current view of regulations governing medical devices and IVDs, and covers the entire medical device lifecycle, from product development through postmarketing.
On-demandOn-demand
Impact of MDR on Drug-Device Combination Products: Notified Body Opinion and CE Mark Applications (On-Demand)
6.0 RAC Credits
Member: $480 Non-Member: $540
Learn how EU MDR 2017/745 affects integral drug-device combinations and how to develop a complete dossier for Notified Body review.
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
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.
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.
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
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.
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
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 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.
Virtual ProgramsVirtual Programs
Sponsored Webcast: Navigating the UK Drug Approval Landscape Post-Brexit
Thursday, 11 May 2023 (11:00 - 12:00PM)
1.0RAC Credits
Free
This webinar will provide an understanding of the current regulatory landscape in the UK.
Chapter EventsChapter Events
DC/ Baltimore Chapter Webcast: Conducting a Biocompatibility Risk Assessment for a Submission
Tuesday, 09 May 2023 (12:00 - 1:00PM)
1.0RAC Credits
Member: $0 | Nonmember: $25
This presentation will provide a practical approach to aid regulatory professionals drafting a biocompatibility risk assessment to use in preparing various regulatory submissions.
Virtual ProgramsVirtual Programs
Introduction to eCTD: Structuring Your First CTD-based Submission (May 2023)
Monday, 08 May 2023 (10:00 - 5:00PM)
12.0RAC 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.
In-PersonIn-Person
Executive Development Program at the Kellogg School of Management (May 2023)
Sunday, 07 May 2023 (9:00 - 4:00PM)
12.0RAC 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.