Regulatory NewsRegulatory News
This Week at FDA: Restructuring at inspections office, new guidances and staff, and more
Posted 03 February 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. This week, the agency announced the launch of a ...
Regulatory NewsRegulatory News
FDA proposes streamlining inspections office along with new human foods center
Posted 31 January 2023 By Ferdous Al-Faruque
The US Food and Drug Administration has proposed restructuring the Office of Regulatory Affairs (ORA) as part of its efforts to reform its food safety oversight program. Agency heads say the changes will eventually mean more efficiencies...
Regulatory NewsRegulatory News
FDA to resume in-person formal meetings in February
Posted 30 January 2023 By Michael Mezher
After nearly three years of virtual meetings, the US Food and Drug Administration (FDA) on Monday announced it will resume scheduling in-person, face-to-face (FTF) formal meetings with drug and biologics sponsors beginning 13 February 2023.
Regulatory NewsRegulatory News
OIG report highlights shortcomings in FDA’s IT acquisition procedures
Posted 18 January 2023 By Ferdous Al-Faruque
The US Department of Health and Human Services (HHS) Office of Inspector General (OIG) is calling on the Food and Drug Administration (FDA) to improve its processes for buying information technology (IT). Overall, the oversight agency de...
Regulatory NewsRegulatory News
FDA looking externally and internally to develop future IT leaders
Posted 16 January 2023 By Ferdous Al-Faruque
The US Food and Drug Administration (FDA) recently published a report on its plans to prioritize developing a cadre of leaders who can streamline its information technology infrastructure and develop plans to make their systems more effi...
Regulatory NewsRegulatory News
FDA official says pandemic reauthorization bill could drive VALID across finish line
Posted 13 January 2023 By Ferdous Al-Faruque
A top US Food and Drug Administration (FDA) official said that a pandemic funding reauthorization bill could act as a vehicle for in vitro diagnostics reform and discussed other legislative priorities for the agency, such as getting more...
RoundupsRoundups
Euro Roundup: Swissmedic updates decentralized clinical trials plan
Posted 05 January 2023 By Nick Paul Taylor
In 2021, Swissmedic and the Swiss Association of Research Ethics Committees (swissethics) created a position paper on DCTs for medicinal products. The original document, as well as an update released months later, outlined barriers to ru...
Regulatory NewsRegulatory News
US FDA sees boost in FY23 budget proposal but no diagnostics reform
Posted 20 December 2022 By Ferdous Al-Faruque
US lawmakers have negotiated an FY 2023 budget that would increase funding to the US Food and Drug Administration (FDA) by more than $226 million over last year’s budget. While the proposal includes several ancillary measures, it notably...
Regulatory NewsRegulatory News
FDA looks to modeling and simulation tools to streamline product reviews
Posted 28 November 2022 By Ferdous Al-Faruque
The US Food and Drug Administration (FDA) recently published a report on how it uses modeling and simulation (M&S), highlighting the untapped opportunities to improve efficiency and predictability at the agency. Some of the key opportuni...
Regulatory NewsRegulatory News
Prompted by recent recalls, regulators scramble to address novel nitrosamines
Posted 31 October 2022 By Joanne S. Eglovitch
The discovery of novel nitrosamine impurities in pharmaceuticals, coming after the valsartan/nitrosamine crisis of 2018, has caught global regulators and industry by surprise as more products than anticipated are affected by these impuri...
This Week at FDAThis Week at FDA
This Week at FDA: Califf considering diagnostic reform rulemaking, Ashley says goodbye
Posted 28 October 2022 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. Compared to the torrent of guidances issued over...
This Week at FDAThis Week at FDA
This Week at FDA: Guidance tsunami continues, questions about FDA’s accelerated approval pathway
Posted 21 October 2022 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. The US Food and Drug Administration (FDA) has co...
     
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Virtual ProgramsVirtual Programs
Introduction to eCTD: Structuring your first CTD based submission
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
Considerations in 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 webcast 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
REC Webinar: Spotlight on EU Food Regulations
Monday, 27 February 2023 (6:00 - 7:30PM) 1.5 RAC Credits Member: €‎ 0 | €‎ 25
This webcast will provide insights into responsible food research & innovation and the role of regulations in EU, including novel food & health claim requirements.
Virtual ProgramsVirtual Programs
Sponsored Webcast: Minimizing Medication Errors: Designing Safe Container and Carton Labeling
Tuesday, 14 March 2023 (12:00 - 1:00PM) 1.0 RAC Credits Free
In this webinar, experts from Med Safety Board, a subsidiary of the Institute for Safe Medication Practices, will review the significant changes that were incorporated into the finalized FDA guidance.

Books   |   Learning

BooksBooks
Lifecycle Management Through the Rx-to-OTC Switch
Member: $145.00 Nonmember: $200.00
Lifecycle Management Through the Rx-to-OTC Switch is a must read for anyone involved in or responsible for understanding the regulatory requirements and developmental stages of a successful switch program.
BooksBooks
Eclectic Science and Regulatory Compliance: Stories for the Curious
Member: $15.00 Nonmember: $20.00
This is an informative, enjoyable read for individuals involved in the fields of medicine and science and those with curious minds.
BooksBooks
Communication and Negotiation
Member: $15.00 Nonmember: $20.00
This book provides basic and detailed descriptions of the communication and negotiation skills necessary to achieve regulatory excellence.
BooksBooks
Choosing the Right Regulatory Career
Member: $20.00 Nonmember: $25.00
Research the diverse and demanding career options available to regulatory professionals across the industry. From traditional and alternative career pathways, explore the many ways to break into regulatory.
BooksBooks
Promotion of FDA-Regulated Medical Products
Member: $130.00 Nonmember: $180.00
This book expands on RAPS’ 2013 publication, FDA Requirements for Prescription Drug Promotion by John Driscoll, to include prescription devices.
On-demandOn-demand
FDA Forecast: What's Next for the FDA in 2023? (On-Demand)
1.5 RAC Credits
Member: $0 | NonMember: $25
What will the FDA do in 2023? In this timely, lively and informative event, regulatory analysts from POLITICO's AgencyIQ will explain what regulatory professionals should anticipate in the year ahead.
BooksBooks
Key Regulatory Topics: eCTD
Member: $87.50 Nonmember: $112.50
eCTD guidance documents from the ICH, EMA, and FDA.
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.
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.
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.
     
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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 Spring 2023
Member: $495.00 Nonmember: $625.00
Testing Window : 20 March 2023 To 28 April 2023
Registration Deadline : 23 February 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 Spring 2023
Member: $495.00 Nonmember: $625.00
Testing Window : 20 March 2023 To 28 April 2023
Registration Deadline : 23 February 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
Considerations in Preparing for an FDA PAI or BIMO Inspection
Wednesday, 29 March 2023 (12:00 - 1:30PM)
1.5RAC Credits
Member: $175 | NonMember: $200
This webcast 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
Introduction to eCTD: Structuring your first CTD based submission
Wednesday, 22 March 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.
Virtual ProgramsVirtual Programs
Sponsored Webcast: Minimizing Medication Errors: Designing Safe Container and Carton Labeling
Tuesday, 14 March 2023 (12:00 - 1:00PM)
1.0RAC Credits
Free
In this webinar, experts from Med Safety Board, a subsidiary of the Institute for Safe Medication Practices, will review the significant changes that were incorporated into the finalized FDA guidance.
Virtual ProgramsVirtual Programs
REC Webinar: Spotlight on EU Food Regulations
Monday, 27 February 2023 (6:00 - 7:30PM)
1.5RAC Credits
Member: €‎ 0 | €‎ 25
This webcast will provide insights into responsible food research & innovation and the role of regulations in EU, including novel food & health claim requirements.