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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...
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.
In-Person In-Person
Coming Soon Coming Soon
Biologics CMC: Future Trends
Thursday, 27 October 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $1,100 | Nonmember: $1,300
Overview of chemistry, manufacturing and control (CMC) regulatory requirements and best practices associated with biologic and biosimilar products. Emphasis on requirements in US, Europe, and other regions
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.
Virtual Programs Virtual Programs
Preparing to Take the RAC Drugs Exam
Tuesday, 04 October 2022 (11:00 - 4:00PM) 12.0 RAC Credits Members: $970 NonMembers: $1,150
Designed specifically for those preparing to take the RAC Drugs exam. This workshop will be facilitated by a panel of RAC-certified regulatory professionals and focuses on sharpening strategic test-taking skills.
Virtual Programs Virtual Programs
Setting the Standard for Real-World Evidence: Research Methods and Data Quality for Medical Devices
Friday, 05 August 2022 (10:00 - 2:00PM) 6.0 RAC Credits Member: $150 NonMember: $175
Panelists with industry, regulator and health-system perspectives will outline key principles and considerations in designing and executing a real-world evidence study for medical-device evaluation.
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
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
China Drug Regulatory Update
Tuesday, 16 August 2022 (11:00 - 12:30PM) 1.0 RAC Credits This workshop will give drug regulatory professionals specific information, strategies, and insights into drug registration in China. All the information in this workshop will be practical and helpful for regulatory professionals
     
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On-demand On-demand
The COVID-19 Impact: How will Regulatory Emerge from the Pandemic?
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn how regulatory teams are adapting to this global health crisis and what effects it will have in the short and long term.
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.
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
Stay on Track and Get Some Sleep: Marketing Application Best Practices
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Regulatory experts will offer tips and guidance for acceleration, submission leadership, and regulatory strategy from that you can apply to your marketing application to help ensure a successful submission.
On-demand On-demand
Meet the Authors, Regulatory Writing, Second Edition
1.0 RAC Credits
Member: $0.00 Nonmember: $0.00
Hear from the experts who wrote the book on regulatory writing. Authors Lisa DeTora, Jocelyn Jennings and Jenny Grodberg will discuss the new edition’s writers-eye view of regulatory documentation.
On-demand On-demand
US Regulation of Advertising, Promotion and Labeling for Medical Devices
6.0 RAC Credits
Member: $399.00 Nonmember: $499.00
Through presentations, discussions and case studies, this program will examine current guidelines and expectations for medical devices and how they impact the way you communicate with prospective and end users.
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.
Books Books
Choosing the Right Regulatory Career
Member: $20.00 Nonmember: $25.00
Research the diverse and demanding career options available to regulatory professionals across the industry. From traditional and alternative career pathways, explore the many ways to break into regulatory.