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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...
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
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...
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...
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...
Regulatory NewsRegulatory News
Stakeholders offer input on educational materials for rare disease drug development
Posted 22 March 2023 By Jeff Craven
After the US Food and Drug Administration (FDA) solicited comments on an educational program for a new Empower Rare Disease Drug Developers (LEADER 3D) initiative in the Accelerating Rare disease Cures (ARC) program, nearly two dozen sta...
ReconRecon
Recon: FDA weighs another round of COVID boosters for high-risk individuals; Thermo Fisher, Celltrion in running to buy Baxter’s biopharma business
Posted 21 March 2023 By Michael Mezher
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
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
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
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...

Event Calendar

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) 1.5 RAC 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
Preparing to Take the RAC Drugs Exam (May 2023)
Wednesday, 31 May 2023 (11:00 - 4:00PM) 12.0 RAC 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: Get Certified in Regulatory Affairs: Get Your RAC! (May 2023)
Friday, 05 May 2023 (1:00 - 2:00PM) 1.0 RAC 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.
Virtual ProgramsVirtual Programs
RAPS Webcast: Get Certified in Regulatory Affairs: Get Your RAC! (Sept 2023)
Friday, 08 September 2023 (1:00 - 2:00PM) 1.0 RAC 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.
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
Sponsored Webcast: The Foundations of AI: A Non-Technical Introduction for Regulatory Affairs Professionals
Wednesday, 26 April 2023 (11:00 - 12:00PM) 1.0 RAC Credits Price: Free
This program is meant to provide attendees a general foundation on the AI topic to help better understand how this may related to their profession now and in the future.
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.
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.
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
Virtual ProgramsVirtual Programs
China Drug Registration and Reimbursement
Tuesday, 16 May 2023 (1:00 - 2:30PM) 1.5 RAC Credits Member: $175 | NonMember: $200
This workshop will present information on how to register your drug in China and how pricing or market access is determined. What is the best strategy to register and maximize pricing in China.
In-PersonIn-Person
Root Cause Investigation for CAPA (June 2023)
Wednesday, 21 June 2023 (9:00 - 5:00PM) 12.0 RAC 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.

Books   |   Learning

BooksBooks
Key Regulatory Topics: eCTD
Member: $87.50 Nonmember: $112.50
eCTD guidance documents from the ICH, EMA, and FDA.
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.
BooksBooks
Risk Evaluation and Mitigation Strategies for US Drug Development, Second Edition
Member: $37.50 Nonmember: $62.50
A comprehensive analysis FDA’s REMS program, including insight from new guidance documents and recent REMS approvals.
Online CourseOnline Course
Medical Device Certificate ElectiveMedical Device Certificate Elective
Pharmaceutical Certificate ElectivePharmaceutical Certificate Elective
Introduction to Regulatory Affairs in the US and Canada [2.0 RAC]
2.0 RAC Credits
Member: $255.00 Nonmember: $350.00
This course provides an overview of healthcare product regulation across product lines in North America, specifically in the US and Canada.
Online CourseOnline Course
Dual CertificateDual Certificate
Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals (Dual)
Member: $3,625.00 Nonmember: $4,535.00
The Regulatory Affairs Certificate: Medical Devices and Pharmaceuticals is achieved by completing six core and eight elective courses.
BooksBooks
EU Regulatory Acronyms & Definitions, Sixth Edition
Member : $10.00 Nonmember: $15.00
An EU reference guide with entries in biologics, medicinal products, and medical devices.
E-booksE-books
Quality Management Systems for Drugs and Devices (e-book)
Member: $205.00 Nonmember: $285.00
Quality Management Systems for Drugs and Devices presents a comprehensive overview of quality management systems, including quality assurance, GMP, GLP, GCP, and compliance.
BooksBooks
International Regulatory Acronyms & Definitions, Third Edition
Member: $10.00 Nonmember: $15.00
International regulatory terms, definitions, and acronyms that will help you develop a better understanding of international regulations.
BooksBooks
Canadian Regulatory Acronyms & Definitions, Fifth Edition
Member: $10.00 Nonmember: $15.00
For those working in the Canadian market, entries of significance to the Canadian healthcare product industry.
BooksBooks
Terms & Definitions of Japanese Regulatory Affairs
Member: $32.50 Nonmember: $42.50
English translations of the most important Japanese regulatory terms and acronyms.
BooksBooks
Fundamentals of Canadian Pharmaceutical, Biologic and Medical Devices Regulations
Member: $100.00 Nonmember: $150.00
A compilation of Fundamentals of Canadian Pharmaceutical and Biologics Regulations and Fundamentals of Canadian Medical Device Regulations.
BooksBooks
Fundamentals of Japanese Regulatory Affairs, Second Edition (Japanese language)
Member: $55.00 Nonmember: $75.00
This Japanese language version covers premarket and postmarket requirements for healthcare products.
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
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
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.
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
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
China Drug Registration and Reimbursement
Tuesday, 16 May 2023 (1:00 - 2:30PM)
1.5RAC Credits
Member: $175 | NonMember: $200
This workshop will present information on how to register your drug in China and how pricing or market access is determined. What is the best strategy to register and maximize pricing in China.
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
RAPS Webcast: Get Certified in Regulatory Affairs: Get Your RAC! (May 2023)
Friday, 05 May 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.
Virtual ProgramsVirtual Programs
Practical Application of ISO14971: 2019 Risk Management for Medical Devices
Thursday, 04 May 2023 (12:00 - 1:30PM)
1.5RAC 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
Virtual ProgramsVirtual Programs
Sponsored Webcast: The Foundations of AI: A Non-Technical Introduction for Regulatory Affairs Professionals
Wednesday, 26 April 2023 (11:00 - 12:00PM)
1.0RAC Credits
Price: Free
This program is meant to provide attendees a general foundation on the AI topic to help better understand how this may related to their profession now and in the future.
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)
1.0RAC 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
Preparing for an FDA PAI or BIMO Inspection
Wednesday, 29 March 2023 (12:00 - 1:30PM)
1.5RAC 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.
RoundupsRoundups
Latin America Roundup: Colombia’s top regulator quits after 6 months; was key champion of multi-country agency