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India’s Central Drugs Standard Control Organization (CDSCO) has released three draft guidance documents that will reshape how manufacturers of in vitro diagnostics (IVDs) approach performance evaluation, postmarket surveillance and stabi...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...
Virtual Programs Virtual Programs
Preparing to Take the RAC Drugs Exam
Tuesday, 04 October 2022 (11:00 - 4:00PM) 12.0 RAC Credits Members: $970 NonMembers: $1,150
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 Programs Virtual Programs
China NMPA Medical Device Regulations & NEW Revisions and Guidance
Monday, 07 November 2022 (8:00 - 12:00PM) 12.0 RAC Credits Member: $825 NonMember: $970
This interactive, three-day program will explore the fundamentals of Chinese NMPA regulations for medical devices, emphasizing updated revisions and guidance released within the last two years.
On-demand On-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-demand On-demand
Driving Innovation: Planning for CTD Submissions with Language Excellence
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Language service providers can help pharmaceutical companies navigate CTD submissions required by recent regulatory changes in APAC countries such as China.
On-demand On-demand
2020 NMPA (CFDA) Key Updates and Look Ahead on 2021
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
How can manufacturers or inventors be proactively prepared to shorten their time to market for new submissions, allow enough lead time for renewal, and to know when to file for modifications to avoid penalties?
Online Course Online Course
Medical Device Certificate Elective Medical 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-demand On-demand
China NMPA Medical Device Latest & Most Important Policy: Key Highlights of Order 739
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
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.
On-demand On-demand
China NMPA (CFDA) Regulatory Approval: Clinical Evaluation and Pathways
6.0 RAC Credits
Member: $480.00 Nonmember: $540.00
This workshop will cover different clinical evaluation and pathways and how to decide which pathway to choose to support China NMPA medical device/IVD regulatory approval or postmarket study requirements.
On-demand On-demand
China NMPA & US FDA Emergency Approval – Implications to Life Science Companies Relating to COVID-19
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
Our experts will explain related guidelines, emergency approval procedures, urgent importations, how they work in practice, what is required during the COVID-19 crisis, and what to expect moving forward.
Books Books
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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All Results

On-demand On-demand

2021 China NMPA (CFDA) Key Updates and 2022 Forecast (On-Demand)

1.0RAC 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.
Virtual Programs Virtual Programs

Preparing to Take the RAC Drugs Exam

Tuesday, 04 October 2022 (11:00 - 4:00PM)
12.0RAC Credits
Members: $970 NonMembers: $1,150
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 Programs Virtual Programs

China NMPA Medical Device Regulations & NEW Revisions and Guidance

Monday, 07 November 2022 (8:00 - 12:00PM)
12.0RAC Credits
Member: $825 NonMember: $970
This interactive, three-day program will explore the fundamentals of Chinese NMPA regulations for medical devices, emphasizing updated revisions and guidance released within the last two years.
On-demand On-demand

Driving Innovation: Planning for CTD Submissions with Language Excellence

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
Language service providers can help pharmaceutical companies navigate CTD submissions required by recent regulatory changes in APAC countries such as China.
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