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Regulatory NewsRegulatory News
EMA releases final guideline on antibacterial drug development
Posted 24 May 2022 By Joanne S. Eglovitch
The European Medicines Agency (EMA) has issued a final guideline on evaluating antibacterial medicines that is globally aligned with guidance from other regulators.  
Regulatory NewsRegulatory News
MDCG sets out transition periods for legacy diagnostics post-IVDR
Posted 24 May 2022 By Gareth Macdonald
The European Commission’s Medical Device Coordination Group (MDCG) has clarified how long legacy devices can remain on the market after the In Vitro Diagnostic Regulation (IVDR) comes into application.
RoundupsRoundups
Asia-Pacific Roundup: Philippine FDA seeks feedback on abridged procedures for clinical trial applications
Posted 24 May 2022 By Nick Paul Taylor
The Philippine Food and Drug Administration (FDA) is planning to offer an abridged procedure for clinical trial applications by relying on other regulatory authorities. FDA is running a consultation about its draft guidelines on the prop...
ReconRecon
Recon: Pfizer’s ulcerative colitis drug hits endpoints in Phase 3 trials; India’s Serum Institute plans new Africa plant
Posted 24 May 2022 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
FDA takes steps to relax blood donor requirements
Posted 23 May 2022 By Ferdous Al-Faruque
The US Food and Drug Administration published two draft guidances and a revised final guidance that relax its regulatory oversight of blood and blood component donations. The agency says the changes make it easier for donation centers to...
Regulatory NewsRegulatory News
MDCG guidance aims to help manufacturers implement UDIs under MDR and IVDR
Posted 23 May 2022 By Joanne S. Eglovitch
The European Commission’s Medical Device Coordination Group (MDCG) on 20 May issued a   question and answer guidance to help the medical device industry comply with unique device identification (UDI) requirements under the Medical Devic...
Feature ArticlesFeature Articles
FDA guidances for medical device regulation after enforcement discretion and EUA expiration
Posted 23 May 2022 By Ashley Clark, MS, RAC
This article summarizes the requirements for transitioning medical devices, marketed with lowered standards for effectiveness under emergency use authorization (EUA) during the COVID-19 pandemic, after the EUA declaration expires.  Keyw...
Regulatory NewsRegulatory News
Study: Blockbuster, accelerated approval drugs more likely to get new FDA-approved formulation
Posted 23 May 2022 By Jeff Craven
Drugs with blockbuster status and those approved under the US Food and Drug Administration’s (FDA’s) accelerated approval pathway were more likely to receive a new formulation, while other factors like clinical effectiveness were not pre...
Virtual Programs Virtual Programs
Ensure Your MDR Program is State of the Art
Tuesday, 24 May 2022 (12:00 - 1:30PM) 1.5 RAC Credits Price: $0
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.
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
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.
Chapter Events Chapter Events
NY/NJ Chapter Webcast: Panel Discussion on Leadership Journeys: Navigating Career Paths in Regulatory Affairs
Tuesday, 07 June 2022 (12:00 - 1:30PM) 1.5 RAC Credits Member: $0 NonMember: $25
Join us for a panel discussion by six Women Leaders who have navigated and overcome barriers to chart paths for themselves and others in RA.
Chapter Events Chapter Events
Twin Cities Chapter Happy Hour
Wednesday, 08 June 2022 (5:00 - 7:00PM) 0.0 RAC Credits Join us as the RAPS Twin Cities Chapter kicks off our first in-person event for 2022!
Virtual Programs Virtual Programs
Sponsored Webcast: Postmarket Clinical Follow-up Under MDR
Thursday, 09 June 2022 (11:00 - 12:00PM) 1.0 RAC Credits Price: $0
This free webcast will provide an overview of how to plan and execute the PMCF requirements under MDR, taking into consideration key factors such as novelty, longevity on the market, and risk classification.
Chapter Events Chapter Events
Chicago Chapter Webcast: EU IVDR Update
Monday, 13 June 2022 (11:00 - 1:00PM) 2.0 RAC Credits Member: $0 NonMember: $25
Attend this session to learn the latest updates that can help your organization overcome obstacles for placing devices in the EU under MDR and ensure market continuity after the application date.
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.
     
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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
Audits and Inspections: How to Drive a Standardization Strategy that Sticks (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $25
Audits and inspections: how to drive a standardization strategy that sticks
On-demand On-demand
Ensure Your MDR Program is State of the Art (On-Demand)
1.5 RAC 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.
On-demand On-demand
Sponsored Webcast: Smarter Clinical Document Automation Now for your T&D Requirements Later (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $25
This webinar will illustrate how automation through the use of advanced technology allows for the production of clinical documents with future disclosure in mind.
On-demand On-demand
Sponsored Webcast: EU IVDR: Intriguing Insights, Recommended Actions, and a Look Towards the Future
1.0 RAC Credits
Member: $0 NonMember: $25
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.
On-demand On-demand
Meet the Authors: Regulation of Regenerative Medicine: A Global Perspective
1.0 RAC Credits
Price: $0
Hear from the authors who wrote RAPS' latest book, Regulation of Regenerative Medicine: A Global Perspective. Regenerative medicine is a growing field with more countries focused on generating governing regulations.
On-demand On-demand
Sponsored Webcast: What is FDA's Project Optimus and How Will it Impact Oncology Drug Development? (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $25
This webinar will provide information on FDA’s Project Optimus and its potential impacts on oncology drug development.
On-demand On-demand
Sponsored Webcast: The Next Generation of Postmarket Medical Device Surveillance
1.0 RAC Credits
Member: $0 NonMember: $25
Panelists will discuss postmarket medical device surveillance including the Active Surveillance Task Force, Common Data Model, and the Active Surveillance Cloud Infrastructure from a variety of perspectives.

All Results

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

Audits and Inspections: How to Drive a Standardization Strategy that Sticks (On-Demand)

1.0RAC Credits
Member: $0 NonMember: $25
Audits and inspections: how to drive a standardization strategy that sticks
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.
On-demand On-demand

Sponsored Webcast: Smarter Clinical Document Automation Now for your T&D Requirements Later (On-Demand)

1.0RAC Credits
Member: $0 NonMember: $25
This webinar will illustrate how automation through the use of advanced technology allows for the production of clinical documents with future disclosure in mind.
On-demand On-demand

Sponsored Webcast: EU IVDR: Intriguing Insights, Recommended Actions, and a Look Towards the Future

1.0RAC Credits
Member: $0 NonMember: $25
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.
On-demand On-demand

Meet the Authors: Regulation of Regenerative Medicine: A Global Perspective

1.0RAC Credits
Price: $0
Hear from the authors who wrote RAPS' latest book, Regulation of Regenerative Medicine: A Global Perspective. Regenerative medicine is a growing field with more countries focused on generating governing regulations.
On-demand On-demand

Sponsored Webcast: What is FDA's Project Optimus and How Will it Impact Oncology Drug Development? (On-Demand)

1.0RAC Credits
Member: $0 NonMember: $25
This webinar will provide information on FDA’s Project Optimus and its potential impacts on oncology drug development.
On-demand On-demand

Sponsored Webcast: The Next Generation of Postmarket Medical Device Surveillance

1.0RAC Credits
Member: $0 NonMember: $25
Panelists will discuss postmarket medical device surveillance including the Active Surveillance Task Force, Common Data Model, and the Active Surveillance Cloud Infrastructure from a variety of perspectives.
On-demand On-demand

Sponsored Webcast: Building Compliance with an Electronic Quality Management System (On-Demand)

1.5RAC Credits
Member: $0 NonMember: $25
Learn to leverage electronic QMS systems to build compliance. This live broadcast will debunk QMS myths and address the challenges in ensuring data integrity.
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.