Regulatory NewsRegulatory News
CDRH outlines plan to understand sex and gender differences in medical devices
Posted 21 January 2022 By Mary Ellen Schneider
“Now more than ever, we need to understand the implications sex and gender present for the performance of medical devices in all individuals. The CDRH Health of Women program is a comprehensive, collaborative, landmark program built on t...
TrackersTrackers
COVID-19 therapeutics tracker
Posted 21 January 2022 By Jeff Craven
Updated 21 January to include new information on Olumiant, Lagevrio, Regkirona, Paxlovid, Xevudy, Veklury, and ensovibep.
Regulatory NewsRegulatory News
This Week at FDA: Generic drug approvals continue downward trend, new guidance on clinical trial diversity coming
Posted 21 January 2022 By Michael Mezher
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, we look at some newly published data f...
Regulatory NewsRegulatory News
European Parliament endorses legislation bolstering EU’s ability to tackle shortages
Posted 20 January 2022 By Joanne S. Eglovitch
The European Parliament approved legislation to increase the powers of the European Medicines Agency (EMA) in monitoring and responding to drug and device shortages.
ReconRecon
Recon: 27 firms to manufacture Merck’s COVID pill; Blood sample collection tubes land on FDA device shortage list
Posted 20 January 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
FDA offers examples of innovative study designs accepted into CID pilot
Posted 20 January 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) recently highlighted three case studies showing how sponsors can incorporate innovative study designs in their clinical trials using the agency’s Complex Innovative Trial Designs (CID) pilot meet...
RoundupsRoundups
Euro Roundup: MHRA seeks feedback on proposals for the future of UK clinical trial legislation
Posted 20 January 2022 By Nick Paul Taylor
The Medicines and Healthcare products Regulatory Agency (MHRA) is holding a consultation into the future of clinical trial legislation in the UK. MHRA is seeking feedback on tens of proposals intended to streamline processes and remove u...
RoundupsRoundups
FDA Approvals Roundup: Ryaltris, Cibinqo, Rinvoq
Posted 19 January 2022 By Renee Matthews
A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
Virtual Programs Virtual Programs
Biologics CMC: Phase Appropriate Product Development
Thursday, 17 March 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $825 | Nonmember: $970
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
Biologics CMC: Phase Appropriate Product Development
Thursday, 21 July 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $825 Nonmember: $970
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
Biologics CMC: Phase Appropriate Product Development
Thursday, 08 December 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $825 | Non-member: $970
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
Biologics CMC: Regulatory Challenges and Trends
Thursday, 19 May 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $825|Nonmember: $970
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 regulated regions.
Virtual Programs Virtual Programs
COVID-19 In Vitro Diagnostics: A Look into FDA’s Regulatory Response
Thursday, 10 February 2022 (1:00 - 2:00PM) 1.0 RAC Credits Members $0 | Nonmenbers $0 This presentation will discuss the FDA Emergency Use Authorization Guideline and how the guidance has changed over time.
Virtual Programs Virtual Programs
Integrating Human Factors into Your Next Regulatory Submission: Lemons or Lemonade?
Tuesday, 26 April 2022 (9:00 - 2:00PM) 6.0 RAC Credits Member: $495 | Nonmember: $580
This workshop is for the regulatory professional who wants to successfully navigate crucial aspects of human factors and prevent obstacles and risks to your submissions.
Virtual Programs Virtual Programs
US Regulatory Essentials, Devices
Tuesday, 22 March 2022 (10:00 - 3:30PM) 12.0 RAC Credits Members: $825| Nonmembers: $970
This online workshop offers a comprehensive overview of U.S. regulatory affairs for medical devices and IVDs.
Virtual Programs Virtual Programs
Cybersecurity Unauthorized
Tuesday, 08 March 2022 (10:00 - 5:00PM) 12.0 RAC Credits Members: $970 | Nonmembers: $1,150
This workshop will help regulatory and quality professionals develop the knowledge they need to help steer their organizations in the right direction when it comes to global cybersecurity expectations.
     
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E-books E-books
Quality Management Systems for Drugs and Devices
Member: $205.00 Nonmember: $285.00
Quality Management Systems for Drugs and Devices presents a comprehensive overview of quality management systems, including quality assurance, GMP, GLP, GCP, and compliance.
Books Books
Global Medical Device Regulatory Strategy, Second Edition
Member: $205.00 Nonmember: $285.00
Learn to develop a comprehensive global regulatory strategy for medical devices, labeling, clinical, risk management, marketing, and postmarketing.
On-demand On-demand
Managing Global Regulatory Complexity: Five Strategies to Optimize Regulatory Compliance in New Markets
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Join us for a regulatory professional’s presentation on Managing Global Regulatory Complexity: Five Strategies to Optimize Regulatory Compliance in New Markets.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Medical Devices: Definition & Lifecycle [1.0 RAC]
1.0 RAC Credits
Member: $135.00 Nonmember: $185.00
This course acts as a primer—a basic introduction to medical devices and general aspects of product and regulatory lifecycles.
Product Bundle Product Bundle
Regulatory Medical Writing Bundle [Package #1]
Member: $1,050.00 Nonmember: $1,440.00
Learn more about the components of various application types and techniques for improving document quality.
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.
Books Books
Software as a Medical Device
Member: $145.00 Nonmember: $200.00
SaMD will help readers uncover whether their software is subject to global medical device regulations, understand the regulatory implications, and develop their SaMD strategy.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Regulation of IVDs in the US and Major Markets Outside the US [5.0 RAC]
5.0 RAC Credits
Member: $545.00 Nonmember: $745.00
This course provides a basic overview of IVDs, including an historical background focused on regulatory requirements. It introduces key regulations and guidelines necessary for effective product development.