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TrackersTrackers
COVID-19 vaccine tracker
Posted 27 May 2022 By Jeff Craven
Updated 06 May with new information on vaccines from Pfizer/BioNTech, Moderna, Bharat Biotech, Zydus Cadila, Novavax, Medicago and Valneva.
Regulatory NewsRegulatory News
FDA officials reflect on quality maturity model, quality metrics
Posted 27 May 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) has received “positive” feedback from stakeholders that participated in its quality metric management maturity (QMM) programs, said an agency official, the results of which will help inform the d...
Regulatory NewsRegulatory News
This Week at FDAThis Week at FDA
This Week at FDA: Upcoming VRBPAC meetings, Califf on the Hill and ARPA-H gets official
Posted 27 May 2022 By Michael Mezher, 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, FDA announced the dates for three upco...
Regulatory NewsRegulatory News
IVDR implementation day overshadowed by lack of notified bodies, risks to patients
Posted 26 May 2022 By Ferdous Al-Faruque
While the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR) is now in effect, stakeholders are concerned that the road forward is not going to be easy, especially due to the lack of notified body capacity to handle t...
Regulatory NewsRegulatory News
Euro Convergence: SSCP expert lists common mistakes device manufacturers make
Posted 26 May 2022 By Ferdous Al-Faruque
AMSTERDAM – Some of the most common mistakes manufacturers make when complying with safety and clinical performance (SSCP) requirements may sound simple enough to fix, but such issues tend to be persistent, said Rachel Gibbs, principal r...
RoundupsRoundups
Euro Roundup: EMA moves to suspend 100 generic drugs over ‘flawed studies’ run by Indian CRO
Posted 26 May 2022 By Nick Paul Taylor
The European Medicines Agency (EMA) is set to suspend around 100 generic medicines that came to market based on data from “flawed” bioequivalence studies run by the contract research organization (CRO) Synchron Research Services.
ReconRecon
Recon: Lawmakers grill Califf on response to infant formula crisis; Supply chain, China lockdowns cloud Medtronic’s outlook
Posted 26 May 2022 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In-Person In-Person
Cybersecurity Unauthorized
Monday, 27 June 2022 (9:00 - 5:00PM) 12.0 RAC Credits Members: $1,300 | Nonmembers: $1,525
In this two-day, in-person workshop, regulatory experts will develop the knowledge they need to help steer their organizations in the right direction when it comes to global cybersecurity expectations.
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.
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.
Chapter Events Chapter Events
Colorado Chapter Webcast: Best Practices for Management of Companion Diagnostics (CDx) Partnerships
Thursday, 23 June 2022 (4:00 - 5:00PM) 1.0 RAC Credits Member: $0 NonMember: $25
This program will cover the key elements and strategies for effective management of Companion Diagnostics.
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
Biologics CMC: Phase Appropriate Product Development
Thursday, 21 July 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $970 | Nonmember: $1,150
Learn how to handle technical issues affecting biologic product development challenges and expectations in the US, Europe, and other highly regulated regions.
     
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RAC Exam RAC Exam
RAC Drugs Examination Summer 2022
Member: $490.00 Nonmember: $615.00
Testing Window : 11 July 2022 To 19 August 2022
Registration Deadline : 16 June 2022
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.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Supplier Management [3.0 RAC]
6.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course provides a basic understanding of current supplier management practices and their impact on product quality and patient safety.
RAC Exam RAC Exam
RAC Devices Examination Autumn 2022
Member: $490.00 Nonmember: $615.00
Testing Window :
31 October 2022 To 9 December 2022
Registration Deadline : 6 October 2022
RAC Exam RAC Exam
RAC Devices Examination Summer 2022
Member: $490.00 Nonmember: $615.00
Testing Window : 11 July 2022 To 19 August 2022
Registration Deadline : 16 June 2022
Product Bundle Product Bundle
Regulatory Basics Bundle - US & Canada
Member: $400.00 Nonmember: $560.00
This bundle provides fundamental information on product lifecycles, gives insight into professional roles and responsibilities and discusses regulatory mechanisms, processes and agencies within key markets.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Project Management for Regulatory Professionals [4.0 RAC]
4.0 RAC Credits
Member: $465 Nonmember: $640
This course provides guidance for effectively establishing a regulatory development project plan, including identifying resources and determining the effort and timing required to create project and budget reports.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Intermediate Medical Writing: Investigational Applications [6.0 RAC]
6.0 RAC Credits
Member: $570.00 Nonmember: $790.00
This course provides an overview of the variety of investigational applications prepared by regulatory and medical writers for both drugs/biologics and medical devices.

All Results

Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective

Medical Devices: US Regulations [5.0 RAC]

5.0RAC Credits
Member: $545.00 Nonmember: $745.00
This course is intended to provide a basic overview of US medical device regulation.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective

Medical Devices: Advertising and Promotion in the US [3.0 RAC]

3.0RAC Credits
Member: $365.00 Nonmember: $500.00
This course provides information regarding the primary US agencies regulating medical devices and covers their enforcement tools as well as company strategies for avoiding enforcement actions.