Recon: PhRMA weighs legal options as US pricing reforms move through Congress; Europe to consider dose-sparing to increase monkeypox vaccine
Posted 11 August 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Euro Roundup: MDCG posts guidance on notified bodies
Posted 11 August 2022 By Nick Paul Taylor
MDCG created the guidance to support designating authorities responsible for assessing applications for medical device and in vitro diagnostic notified bodies. The text also covers the reassessment and is intended to “bring consistency a...
Regulatory NewsRegulatory News
FDA Official: EU privacy regulations impede BIMO inspections, application reviews
Posted 10 August 2022 By Ferdous Al-Faruque
According to a US Food and Drug Administration (FDA) lawyer, the European Union’s privacy regulations are a headache for researchers and regulators trying to share data. Heather Messick, the former lead policy analyst on the EU’s General...
Regulatory NewsRegulatory News
Legal Expert: Too early to tell if SCOTUS ruling will chill FDA regulation
Posted 09 August 2022 By Ferdous Al-Faruque
When the majority of the US Supreme Court (SCOTUS) in late June said that an Obama-era Environmental Protection Agency (EPA) policy to curb climate change was a regulatory overreach, legal experts wondered if it would have a chilling eff...
Asia-Pacific Roundup: Malaysian device authority posts code of ethics and conduct
Posted 09 August 2022 By Nick Paul Taylor
Malaysia’s Medical Device Authority (MDA) has released a code of ethics and conduct that describes its approach to subjects such as conflicts of interest, confidentiality and the receipt of gifts.
Recon: Pharma industry laments Senate drug pricing bill; GSK, Mersana sign $1.4B preclinical ADC deal
Posted 09 August 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Recon: Senate passes major drug pricing reforms; Pfizer to buy Global Blood Therapeutics for $5.4B
Posted 08 August 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
This Week at FDAThis Week at FDA
This Week at FDA: EtO, user fee woes, and product specific guidances
Posted 05 August 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. This week the Environmental Protection Agency (EP...
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.
Virtual Programs Virtual Programs
Sponsored Webcast: A Regulatory and Strategic Framework for Facilitating Pediatric Drug Development
Thursday, 22 September 2022 (11:00 - 12:00PM) 1.0 RAC Credits Member: $0 | Nonmember: $0
During the webinar, pediatric development experts will provide an overview of the global regulatory framework and requirements that drive pediatric development.
Books Books
The European In Vitro Diagnostic Regulation
Member: $295.00 Nonmember: $395.00
RAPS has teamed up with Meddev Solutions to offer a practical guide to implementing the EU IVDR.
On-demand On-demand
Understanding and Applying FDA’s 510(k) Modifications Guidance
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will review key aspects of the guidance, provide historical and other perspectives on its use, and present ideas on how to effectively implement it.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Medical Devices: Postmarket Surveillance [4.0 RAC]
4.0 RAC Credits
Member: $465.00 Nonmember: $640.00
This course highlights the requirements and importance of an effective postmarket surveillance program that satisfies the regulatory and quality system requirements in the US, Canada and Europe.
Books Books
Fundamentals of International Regulatory Affairs, Fifth Edition
Members: $295 Nonmembers: $395
This edition discusses regulatory changes that have occurred globally and technologically with a focus on drugs and medical devices.
Books Books
Fundamentals of EU Regulatory Affairs, Ninth Edition
Members: $295 Nonmembers: $395
Learn about the transformation of the EU healthcare product regulatory landscape, including the impact of Brexit and EMA’s move from London to Amsterdam.
Books Books
Complete WHO Guidance Documentation Bundle
Member: $15.00 Nonmember: $22.50
A WHO bundle with six guidance documents addressing pharmaceuticals, medical devices, psychotropic substances and plasma.
On-demand On-demand
Sponsored Webcast: Why UDI is a Regulatory Issue and Not Just an Operational Process (On-Demand)
1.0 RAC Credits
Members: $0 | Nonmembers: $25
Simplify UDI complexity by exploring requirements across several major markets, including the types of devices that are covered and the expected implementation timelines.
On-demand On-demand
PMCF User Feedback Surveys: Practical Solutions, Lessons Learned, and Processes for Success
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will provide practical solutions to leveraging user feedback surveys as PMCF activities under the EU MDR, presented by former notified body leadership and PMCF subject matter experts.

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RAC Prep Bundle RAC Prep Bundle

RAC (Devices) Flashcards

Member: $40.00 Nonmember: $50.00
Study devices terminology at your fingertips in an easy-to-use flashcard format.
On-demand On-demand

Ensure Your MDR Program is State of the Art (On-Demand)

1.5RAC Credits
Member:$0 NonMember:$25
This webcast will cover how this definition in context of the formal MDR and MEDDEV references impacts technical documentation, risk analysis, clinical, and postmarket documentation.
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RAPS congratulates 108 spring RAC exam passers