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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.
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...
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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Books Books
International Combination Products
Member: $130.00 Nonmember: $180.00
This book provides an in-depth look at this breakthrough field and covers three major regulatory regions – the US, Canada, and Europe.
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
PMS Requirements of the EU MDR: Implementation Challenges and Solutions
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will go into detail about strategies to overcome audit findings and gaps in your evidence.
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.
On-demand On-demand
Are You Ready to Begin Planning your IND Submission?
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Regulatory experts will offer advice pertaining to selecting a target indication, seeking pre-IND advice from FDA, deciding whether to use US or non-US sites for early clinical research, and more.
On-demand On-demand
Impact of MDR on Drug-Device Combination Products: Notified Body Opinion and CE Mark Applications (On-Demand)
6.0 RAC Credits
Member: $480 Non-Member: $540
Learn how EU MDR 2017/745 affects integral drug-device combinations and how to develop a complete dossier for Notified Body review.
On-demand On-demand
EU MDR Prep: Translation Requirements That Will Make or Break Your Devices In Europe
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
The presenters will outline essential information and considerations for device manufacturers across the EU and explain everything you need to do to remain compliant.
RAC Exam RAC Exam
RAC Drugs Examination Autumn 2022
Member: $490.00 Nonmember: $615.00
Testing Window :
31 October 2022 To 9 December 2022
Registration Deadline : 6 October 2022