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RoundupsRoundups
Asia-Pacific Roundup: New Zealand’s Medsafe tweaks fee increase proposal after industry feedback
Posted 17 May 2022 By Nick Paul Taylor
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has revised its upcoming fee changes in light of industry feedback on the draft proposal. Medsafe is retaining the proposed 4.2% increase across all fees but making...
ReconRecon
Recon: Lilly scores approval for next-gen type 2 diabetes drug; FDA’s RWE pilot cites challenges in emulating RCTs
Posted 16 May 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
ReconRecon
Recon: Moderna completes EUA submission for younger kids and adolescents; Generic firms to cap price of Paxlovid copies at $25 in low-income countries
Posted 12 May 2022 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
Pandemic highlighted challenges of ATMP clinical trials in Europe
Posted 12 May 2022 By Denise Fulton
Mortazavi pointed out that between 2014 and 2018, new clinical trials for ATMPs started in the US increased by 36%, while Asia saw a 28% increase. During the same period, trials started in Europe increased by less than 2%. While the reas...
RoundupsRoundups
Asia-Pacific Roundup: TGA commissions independent report on risks of self-harm from paracetamol misuse
Posted 10 May 2022 By Nick Paul Taylor
Australia’s Therapeutic Goods Administration (TGA) has commissioned an independent expert report into the risks of intentional self-poisoning with paracetamol. The report will look at how current access controls for paracetamol manage th...
ReconRecon
Recon: Congress considers accelerated approval reforms in user fee bill; Quality concerns prompt Novartis to stop manufacturing cancer therapies at two sites
Posted 05 May 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
RoundupsRoundups
Asia-Pacific Roundup: TGA provisional determination for Moderna’s bivalent COVID vaccine
Posted 03 May 2022 By Nick Paul Taylor
TGA has granted provisional determination to Moderna for the investigational vaccine, referred to in the statement as Spikevax Bivalent Zero/Omicron.
ReconRecon
Recon: Pfizer’s Paxlovid fails to show benefit for COVID prevention; FDA places hold on Vertex’s diabetes study
Posted 02 May 2022 By Joanne S. Eglovitch
Pfizer says COVID treatment Paxlovid fails to prevent infection of household members  Vertex Falls After FDA Halts Diabetes Study in Surprise Move  Moderna asks Canada for extension of COVID vaccine to young children ( Reuters ) Pro...
Virtual Programs Virtual Programs
China NMPA Medical Device Regulations & NEW Revisions and Guidance
Tuesday, 07 June 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.
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.
Chapter Events Chapter Events
Ontario Chapter Webcast: What, Why and When of Postmarket Clinical Follow-up
Thursday, 21 July 2022 (12:00 - 1:00PM) 1.0 RAC Credits PMCF is now an expectation for many medical devices. As the expectations for EU MDR become clear, PMCF can still be confusing. We will review what may qualify for PMCF, what is required, and when it is required.
Virtual Programs Virtual Programs
China Drug Regulatory Update
Tuesday, 16 August 2022 (11:00 - 12:30PM) 1.0 RAC Credits This workshop will give drug regulatory professionals specific information, strategies, and insights into drug registration in China. All the information in this workshop will be practical and helpful for regulatory professionals
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.
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 (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
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?
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 & 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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