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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...
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
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
Preparing to Take the RAC Devices Exam - Oct 2022
Tuesday, 11 October 2022 (5:00 - 8:30PM) 6.0 RAC Credits Members: $580|Non-members: $680
For those preparing to take the RAC Devices exam. Workshop will focus on critical, analytical & strategic test-taking skills and be facilitated by a panel of regulatory professionals who have earned their RAC.
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.
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.
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.
Chapter Events Chapter Events
Ontario Chapter Webcast: What, Why and When of Postmarket Clinical Follow-up
Thursday, 21 July 2022 (12:00 - 1:00PM) 1.0 RAC Credits PMCF is now an expectation for many medical devices. As the expectations for EU MDR become clear, PMCF can still be confusing. We will review what may qualify for PMCF, what is required, and when it is required.
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
     
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E-books E-books
Orphan Drug Development for Rare Diseases (e-book)
Member: $130.00 Nonmember: $180.00
Orphan Drug Development for Rare Diseases covers every aspect of orphan drug development. Topics include incentives, benefits, patient engagement, designation, marketing authorization, and market access.
On-demand On-demand
Understanding and Applying FDA’s 510(k) Modifications Guidance
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will review key aspects of the guidance, provide historical and other perspectives on its use, and present ideas on how to effectively implement it.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Medical Devices: Postmarket Surveillance [4.0 RAC]
4.0 RAC Credits
Member: $465.00 Nonmember: $640.00
This course highlights the requirements and importance of an effective postmarket surveillance program that satisfies the regulatory and quality system requirements in the US, Canada and Europe.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Pharmaceuticals: Canadian Regulations [6.0 RAC]
6.0 RAC Credits
Member: $570.00 Nonmember: $790.00
This course will introduce you to essential areas of regulatory knowledge for a broad range of pharmaceutical, radiopharmaceutical and biologic products in Canada.
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
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Regulation of Generic Drugs in the US [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course provides a basic understanding of the legal and regulatory structure of generic drugs in the US.
Books Books
Fundamentals of Canadian Pharmaceutical, Biologic and Medical Devices Regulations
Member: $100.00 Nonmember: $150.00
A compilation of Fundamentals of Canadian Pharmaceutical and Biologics Regulations and Fundamentals of Canadian Medical Device Regulations.
Product Bundle Product Bundle
Regulatory Medical Writing Bundle [Complete Package]
Member: $1,240.00 Nonmember: $1,710.00
Learn more about the components of various application types and techniques for improving document quality.