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Regulatory NewsRegulatory News
Study: Limited API suppliers pose threat to generic drug supply chain
Posted 17 February 2023 By Mary Ellen Schneider
Surveillance of the generic drug supply chain has typically focused on the number of manufacturers of finished drug products, but that approach may overlook vulnerabilities from having a limited number of suppliers of active pharmaceutic...
RoundupsRoundups
Asia-Pacific Roundup: Singapore’s HSA finds benefits outweigh risks for JAK inhibitors
Posted 20 December 2022 By Nick Paul Taylor
HSA conducted its review in response to the findings of ORAL Surveillance, a post-authorization safety study that linked Xeljanz to a higher risk of major adverse cardiovascular events and cancers than Humira (adalimumab), a TNF inhibito...
RoundupsRoundups
Asia-Pacific Roundup: Pakistan’s DRAP tells companies to test solvents amid oral drug contamination concerns
Posted 25 October 2022 By Nick Paul Taylor
Contamination with diethylene glycol (DEG) and ethylene glycol (EG) can cause symptoms including abdominal pain and diarrhea and ultimately lead to death, particularly in children. The threat of the contaminants has been highlighted by ...
RoundupsRoundups
Asia-Pacific Roundup: TGA seeks feedback to reduce paracetamol poisoning
Posted 20 September 2022 By Nick Paul Taylor
TGA commissioned the report in response to the rising prevalence of intentional paracetamol poisoning, especially among young people, involving paracetamol purchased without the oversight of a pharmacist in supermarkets and convenience s...
A history of expedited pathways: Breakthrough therapy designation, PRIME, Sakigake, and ILAP
Posted 19 July 2022 By Maurice Bancsi, PhD
It can take at least a year to 18 months to get a new medicinal product approved in the US, European Union, or United Kingdom. Over the last decade, regulators have introduced initiatives to shorten the time to market for medicines that ...
RoundupsRoundups
Asia-Pacific Roundup: India releases a trio of IVD guidances for consultation
Posted 12 July 2022 By Nick Paul Taylor
India’s Central Drugs Standard Control Organization (CDSCO) has released three draft guidance documents that will reshape how manufacturers of in vitro diagnostics (IVDs) approach performance evaluation, postmarket surveillance and stabi...
RAPS AnnouncementsRAPS Announcements
RAPS' LatestRAPS' Latest
Here’s what’s new in Fundamentals of Medical Device Regulations, Fifth Edition
Posted 01 July 2022 By Ryan Connors
Regulatory professionals need a new guide to medical device regulations. We just wrote one.
RoundupsRoundups
Asia-Pacific Roundup: TGA fines companies over rapid COVID test imports
Posted 19 April 2022 By Nick Paul Taylor
“This matter serves as a reminder to businesses to only purchase stock of therapeutic goods approved for the Australian market. Any RATs imported for commercial supply must be the version manufactured and approved for the Australian mark...
Regulatory NewsRegulatory News
FDA officials look outward to improve the expedited drug approval process
Posted 31 January 2022 By Kari Oakes
Some flexibility probably should be baked into a time-limited expedited approval system to account for unforeseen and indication-specific issues with confirmatory trials, according to the authors.
Regulatory NewsRegulatory News
Industry calls for technical, scope changes in ICH S12 guideline
Posted 10 November 2021 By Michael Mezher
In response to the US Food and Drug Administration's (FDA) consultation on the International Council for Harmonisation's (ICH) S12 guideline on nonclinical biodistribution considerations for gene therapy products, two industry groups and...
Regulatory NewsRegulatory News
ICH stakeholders contemplate initiative’s future upon its 30th anniversary
Posted 25 October 2021 By Jeff Craven
The International Council for Harmonisation (ICH) has issued a 30th anniversary publication that reflects on its history and surveys stakeholders to see where they see the initiative headed in the future.
Feature ArticlesFeature Articles
July’s Regulatory Focus: Real-world data, real-world evidence
Posted 03 August 2021 By Renee Matthews
Feature articles during July focused on real-world data and evidence (RWD and RWE) and their application to approval processes, labeling, clinical use, and marketing of medical. Articles examined RWD and RWE in the context of patient out...

Event Calendar

Virtual ProgramsVirtual Programs
RAPS Webcast: Post-Market Surveillance of Medical Devices in China, Japan, and South Korea
Thursday, 18 May 2023 (12:00 - 1:00PM) 1.0 RAC Credits Price: Free
The presentation will provide an overview of the post-market surveillance system of medical devices in China, Japan, and South Korea.
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
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.
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).

Books   |   Learning

On-demandOn-demand
2021 China NMPA (CFDA) Key Updates and 2022 Forecast (On-Demand)
1.0 RAC Credits
Members: $0 | Nonmembers: $25
This webcast will show how manufacturers can expedite the path to market for new China NMPA submissions. It will cover Order 739, when to file for modifications, how to keep medical devices compliant, and more.
On-demandOn-demand
2022 NMPA (CFDA) Key Updates and Look Ahead (On-Demand)
1.0 RAC Credits
Member: $0 | NonMember: $25
In this webcast, key policies, guidelines, and standards will be reviewed. Manufacturers and Inventors can implement techniques to shorten their time to market.
On-demandOn-demand
RAPS Webcast: Overview PMS Key Updates: China QMS/GMP Compliance per Order 739 (On-Demand)
1.0 RAC Credits
Member: $0 | NonMember: $25
This webcast recording will teach you about updated requirements in GMP and post market supervision for State Order 739: “Regulations on Supervision and Administration of Medical Devices"
Online CourseOnline Course
Medical Device Certificate ElectiveMedical Device Certificate Elective
Medical Devices: China, Japan, Singapore and South Korea Regulatory Overview [4.0 RAC]
4.0 RAC Credits
Member: $465.00 Nonmember: $640.00
This course examines and introduces medical device regulations and registration requirements in China, South Korea, Japan and Singapore.
On-demandOn-demand
China NMPA Medical Device Latest & Most Important Policy: Key Highlights of Order 739 (On-Demand)
1.0 RAC Credits
Member: $0.00 Nonmember: $25.00
Review the key highlights of this new policy and the implications for overseas companies in premarket submission clinical and technical requirements, innovation focus, MAH and post market changes.
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 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.
Virtual ProgramsVirtual Programs
RAPS Webcast: Post-Market Surveillance of Medical Devices in China, Japan, and South Korea
Thursday, 18 May 2023 (12:00 - 1:00PM)
1.0RAC Credits
Price: Free
The presentation will provide an overview of the post-market surveillance system of medical devices in China, Japan, and South Korea.
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
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
China NMPA Regulations on IVD and Companion Diagnostics (April 2023)
Tuesday, 11 April 2023 (8:30 - 12:30PM)
12.0RAC Credits
Member: $970 NonMember: $1150
This workshop will focus on the latest NMPA regulations for In Vitro Diagnostics (IVD) products and companion diagnostics (CDx).
Regulatory NewsRegulatory News
Study: Limited API suppliers pose threat to generic drug supply chain
On-demandOn-demand
2022 NMPA (CFDA) Key Updates and Look Ahead (On-Demand)
1.0RAC Credits
Member: $0 | NonMember: $25
In this webcast, key policies, guidelines, and standards will be reviewed. Manufacturers and Inventors can implement techniques to shorten their time to market.
RoundupsRoundups
Asia-Pacific Roundup: Singapore’s HSA finds benefits outweigh risks for JAK inhibitors
On-demandOn-demand
RAPS Webcast: Overview PMS Key Updates: China QMS/GMP Compliance per Order 739 (On-Demand)
1.0RAC Credits
Member: $0 | NonMember: $25
This webcast recording will teach you about updated requirements in GMP and post market supervision for State Order 739: “Regulations on Supervision and Administration of Medical Devices"
RoundupsRoundups
Asia-Pacific Roundup: Pakistan’s DRAP tells companies to test solvents amid oral drug contamination concerns
RoundupsRoundups
Asia-Pacific Roundup: TGA seeks feedback to reduce paracetamol poisoning
A history of expedited pathways: Breakthrough therapy designation, PRIME, Sakigake, and ILAP
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