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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...
Regulatory NewsRegulatory News
FDA works to advance real-world data collection in pregnancy and lactation
Posted 16 May 2022 By Mary Ellen Schneider
The US Food and Drug Administration (FDA) is working on ways to facilitate greater use of real-world data (RWD) to help understand the safety and efficacy of medications used during pregnancy and lactation.
This Week at FDAThis Week at FDA
Regulatory NewsRegulatory News
This Week at FDA: House holds user fee markup, CDER’s ARC for rare diseases
Posted 13 May 2022 By Michael Mezher
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, we saw legislation to reauthorize the ...
RAPS AnnouncementsRAPS Announcements
RAPS' LatestRAPS' Latest
500+ gather in Amsterdam for Euro Convergence, RAPS’ largest-ever European event
Posted 12 May 2022 By Zachary Brousseau
RAPS today wrapped up the final day of Euro Convergence 2022, which took place live and in-person in Amsterdam after being held virtually the previous two years and drew more than 500 participants from six continents and 33 countries.
RoundupsRoundups
Euro Roundup: EMA updates annexes on procedures for running GCP inspections
Posted 12 May 2022 By Nick Paul Taylor
The European Medicines Agency (EMA) has updated a set of 15-year-old annexes about the procedures for conducting good clinical practice (GCP) inspections requested by the Committee for Medicinal Products for Human Use (CHMP).
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
Euro Convergence: Attendees want end to regulatory ‘micromanagement’
Posted 12 May 2022 By Ferdous Al-Faruque
AMSTERDAM – Regulatory professionals have a big ask for regulators and other health authorities: Trust us.
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...
Chapter Events Chapter Events
NY/NJ Chapter Webcast- Decision-Making Overview of RWD/RWE Guidances (and RWE Use Successes and Pitfalls)
Monday, 23 May 2022 (12:00 - 1:00PM) 1.0 RAC Credits Member: $0 NonMember: $25
The use of real-world evidence can accelerate drug development and product approvals. However, the acceptable use of real-world evidence for regulatory purposes is a rapidly evolving area where industry.
Virtual Programs Virtual Programs
The Digital Transformation of MedTech Regulatory Affairs
Thursday, 16 June 2022 (11:00 - 12:30PM) 1.5 RAC Credits Members: $175| Nonmembers: $200
Learn how organizations can respond to the growing adoption of digital solutions by global regulatory agencies and how to process a higher volume of submissions, while improving data quality and consistency.
In-Person In-Person
Regulatory Leadership
Thursday, 20 October 2022 (9:00 - 5:00PM) 0.0 RAC Credits Members: €1080 | Nonmembers: €1265
Learn the typical career routes you can take as a Regulatory professional. This workshop will increase your awareness of what leadership means, particularly when it comes to Regulatory and Quality.
Virtual Programs Virtual Programs
US Regulation of Advertising, Promotion, and Labeling for Medical Devices (2022)
Wednesday, 25 May 2022 (12:00 - 4:00PM) 6.0 RAC Credits Members: $580 NonMembers: $680
This virtual program will examine current guidelines and expectations for medical devices and how they impact the way you communicate with prospective and end users.
Virtual Programs Virtual Programs
Sponsored Webcast: EU IVDR: Intriguing Insights, Recommended Actions, and a Look Towards the Future
Tuesday, 17 May 2022 (11:00 - 12:30PM) 1.5 RAC Credits Members: $0 | Nonmembers: $0
Leveraging notified body expertise and real life industry feedback, this webcast is designed to reflect on lessons learned under the IVDR and discuss what the future may look like for diagnostics in Europe.
Virtual Programs Virtual Programs
Introduction to Regulatory Submissions in the eCTD Format - June 2022
Thursday, 23 June 2022 (10:00 - 5:00PM) 12.0 RAC Credits Members: $970| Nonmembers: $1,150
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.
In-Person In-Person
The Evolving Global UDI Requirements
Wednesday, 29 June 2022 (9:00 - 4:00PM) 12.0 RAC Credits Members: $1,300 | Nonmembers: $1,525
In this two-day, in-person workshop, regulatory experts will cover global UDI requirements and their impact on device manufacturers.
In-Person In-Person
Survivor: The FDA 510(k) Program Edition
Monday, 27 June 2022 (9:00 - 4:00PM) 12.0 RAC Credits Members: $1,300 | Nonmembers: $1,525
In this two-day, in-person workshop, you will gain an understanding of the 510(k) program and strategies to help obtain a positive clearance decision.
     
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On-demand On-demand
Chapter Webcast: Best Practices for Management of Companion Diagnostics (CDx) Partnerships (On-Demand)
Member: $0 NonMember: $25
This program will cover the key elements and strategies for effective management of Companion Diagnostics.
On-demand On-demand
Sponsored Webcast: Early Clinical, CMC, and Device Development Considerations Unique to Cellular and Gene Therapy Products (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $25
This webcast will cover the development and regulatory process for new therapeutics, proven strategies that help reduce risk of failure, and how to streamline clinical development and increase speed to market.
On-demand On-demand
COVID-19 In Vitro Diagnostics: A Look into FDA’s Regulatory Response
1.5 RAC Credits
Member: $0 NonMember: $25
This presentation will discuss the FDA Emergency Use Authorization Guideline and how the guidance has changed over time.
On-demand On-demand
How Huvepharma Maintains Quality and Innovation in a High Growth Environment
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn the need-to-know information for providing your promotional materials submissions in the eCTD format.
Books Books
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.
Books Books
The European Medical Device Regulation (2021 Update)
Member: $295.00 Nonmember: $395.00
Your “go-to” EU MDR guide and tool kit intended to be your companion to reference time and time again.
On-demand On-demand
Are you prepared for June 24th? FDA Promotional Materials Submissions in eCTD Format
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn the need-to-know information for providing your promotional materials submissions in the eCTD format.
On-demand On-demand
Learn to Comply With China's UDI Submissions Requirements
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
Overview of key UDI-related regulations, lessons learned from the first batch pilot, and guidance on how to comply with requirements.