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Regulatory NewsRegulatory News
Medtech groups want more time to implement FDA’s QMSR rule
Posted 25 May 2022 By Ferdous Al-Faruque
Medical device lobby groups say they support the US Food and Drug Administration’s plan to align its Quality System Regulations (QSR) with the international quality system standard, but they want more than a year to make the transition.
Regulatory NewsRegulatory News
FDA issues Q&A on importation of prescription drugs from Canada
Posted 25 May 2022 By Mary Ellen Schneider
The US Food and Drug Administration (FDA) has offered some clarity on the legal requirements for small entities to import prescription drugs from Canada.
Regulatory NewsRegulatory News
House GOP reps question FDA commissioner on drugs with China-only data, trial site inspections
Posted 25 May 2022 By Jeff Craven
Republicans in the House Committee on Energy and Commerce have sent a letter to US Food and Drug Administration (FDA) Commissioner Robert Califf asking him to provide information about drugs approved solely based on data from clinical tr...
ReconRecon
Recon: Teva, Allergan reach $161.5M opioid settlement with W. Virginia; Pfizer pledges to sell drugs at no profit in low-income countries
Posted 25 May 2022 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
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...
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.
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.
Virtual Programs Virtual Programs
Sponsored Webcast: Audits and Inspections: How to Drive a Standardization Strategy that Sticks
Wednesday, 22 June 2022 (2:00 - 3:00PM) 1.0 RAC Credits Price: Free
Attend this free webcast to learn how implementing standardized and consistent methods can reduce your risk, strengthen your processes and develop robust, repeatable quality.
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.
     
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Online Course Online Course
Ethics--Essential Tools for Regulatory Professionals [4.0 RAC]
4.0 RAC Credits
List Price: $640 Member: $465
This course identifies and analyzes ethical issues regulatory professionals may encounter and provides a general introduction to complex concepts, principles and theories, including bioethics and legal principles.
On-demand On-demand
Sponsored Webcast: eCTD Submission Challenges (On-Demand)
1.0 RAC Credits
Members: $0 | Nonmembers: $25
Regulatory operations specialist Joshua Lett will explore how challenges in eCTD submissions may provide opportunities for personal and professional growth.
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.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Good Clinical Practice (GCP) [2.0 RAC]
2.0 RAC Credits
Member: $255.00 Nonmember: $350.00
This course identifies the regulations on the proper conduct of clinical research with human subjects that were put in place due to ethical issues in human research.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Introductory Medical Writing [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course provides an overview of the medical writing profession from a regulatory perspective, including an introduction to the basic skills important for medical writing in that field.
Books Books
Regulatory Writing: An Overview, Second Edition
Member: $160.00 Nonmember: $225.00
This new edition is a valuable resource for professionals engaged in designing, composing, compiling, or commenting on regulatory documentation.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Pharmacovigilance [4.0 RAC]
4.0 RAC Credits
Member: $465.00 Nonmember: $640.00
This introductory course provides an overview of pharmacovigilance across a spectrum of topics, presenting both US and global perspectives.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Good Manufacturing Practice (GMP) [4.0 RAC]
4.0 RAC Credits
Member: $465.00 Nonmember: $640.00
This course provides a basic understanding of current Good Manufacturing Practice (CGMP) regulations and their impact on product quality and patient safety.

All Results

Online Course Online Course

Ethics--Essential Tools for Regulatory Professionals [4.0 RAC]

4.0RAC Credits
List Price: $640 Member: $465
This course identifies and analyzes ethical issues regulatory professionals may encounter and provides a general introduction to complex concepts, principles and theories, including bioethics and legal principles.
On-demand On-demand

Sponsored Webcast: eCTD Submission Challenges (On-Demand)

1.0RAC Credits
Members: $0 | Nonmembers: $25
Regulatory operations specialist Joshua Lett will explore how challenges in eCTD submissions may provide opportunities for personal and professional growth.