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Regulatory NewsRegulatory News
ICH recaps progress made over past year, charts new topics
Posted 29 November 2021 By Joanne S. Eglovitch
The International Council for Harmonisation (ICH) announced that “significant milestones” were reached over the past year, including the adoption of the widely anticipated guideline on general considerations for clinical studies and the ...
Regulatory NewsRegulatory News
GDUFA III fiscal details emerge
Posted 18 November 2021 By Kari Oakes
The GDUFA III commitment letter devotes several pages to describing plans for “continued enhancement of user fee resource management,” with an emphasis on achieving sustainability of program resources and ensuring that the program can me...
Regulatory NewsRegulatory News
Industry, clinician groups have different wish lists for AI/ML-enabled device labels
Posted 18 November 2021 By Mary Ellen Schneider
Medical device industry groups are urging the U.S. Food and Drug Administration (FDA) not to rush to create new regulatory requirements around the labeling of medical devices that incorporate artificial intelligence or machine learning (...
Regulatory NewsRegulatory News
CHMP recommends 11 new medicines for authorization, including two COVID-19 monoclonal antibodies
Posted 16 November 2021 By Joanne S. Eglovitch
The European Medicine Agency’s (EMA) Committee for Medicinal Products (CHMP)   last week recommended 11 new medicines for approval in the EU, including Europe’s first two new monoclonal antibodies for treating COVID-19. The agency also ...
Feature ArticlesFeature Articles
Global pediatric development: Challenges, potential solutions, and opportunities
Posted 15 November 2021 By Melodi McNeil, RPh, MS
The US and EU require sponsors to evaluate their drugs for use in children. The low prevalence of many conditions in children means sponsors commonly want to conduct one pediatric development program that satisfies the requirements of bo...
Regulatory NewsRegulatory News
This Week at FDA: CDRH and Endologix leaks, OTC monograph reform, and more
Posted 12 November 2021 By Kari Oakes
Welcome to week 2 of This Week at FDA . We've again gathered the week’s news from (and about) FDA. Each Friday, we'll be covering agency activities and enforcement actions, filings in the  Federal Register , new guidances, legislative u...
RoundupsRoundups
Euro Roundup: EU extends scope of guideline on clinical trials with genetically modified human cells
Posted 11 November 2021 By Nick Paul Taylor
The European Union has extended the scope of its good practice guideline on the assessment of the genetically modified organism (GMO)-related aspects of clinical trials that study human cells. Officials have revised the text to cover hum...
Regulatory NewsRegulatory News
This Week at FDA: New proposed rules, Biocon's Form 483, and more
Posted 05 November 2021 By Michael Mezher
We're trying something new at Regulatory Focus , with the goal of gathering the week’s news from (and about) FDA in one place. We'll be covering agency activities and enforcement actions, filings in the Federal Register , new guidances...
In-Person In-Person
Executive Development Program at the Kellogg School of Management
Sunday, 22 May 2022 (9:00 - 4:00PM) 12.0 RAC Credits The only leadership program dedicated to regulatory professionals like you that combines regulatory experts with faculty from one of the most prestigious business schools in the US, the Kellogg School of Management at Northwestern University.
In-Person In-Person
Europe Europe
Software as a Medical Device
Tuesday, 15 February 2022 (9:00 - 5:00PM) 12.0 RAC Credits Members: € 945 Nonmembers: € 1,120
Review current and evolving regulatory requirements for software as a medical device in order to navigate the challenging expectations for software products.
Virtual Programs Virtual Programs
Sponsored Webcast: Combination Products: Regulatory Approach and cGMP Requirements
Wednesday, 01 December 2021 (12:00 - 1:00PM) 1.0 RAC Credits Member: $0 Non Member: $0
This webinar will walk you through the regulatory approach and the new regulations applied for combination products.
Virtual Programs Virtual Programs
Biologics CMC: Phase Appropriate Product Development
Tuesday, 14 December 2021 (9:00 - 4:00PM) 12.0 RAC Credits Member: $800 Nonmember: $900
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
Sponsored Webcast: Best Practices on MDR Transition Under Current Conditions
Wednesday, 15 December 2021 (11:00 - 12:00PM) 1.0 RAC Credits Member: $0 NonMember: $0
As one of the leading Notified Bodies in these transition cases, BSI will share a series of lessons learned from actual case reports of manufacturers moving through the transitioning to applying the EU MDR
Virtual Programs Virtual Programs
Software as a Medical Device
Tuesday, 25 January 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $970 Nonmember: $1,150
Join regulatory experts to explore the evolving global regulatory requirements affecting SaMD, including determining when software is considered regulated as SaMD and how to determine correct class/classifications.
Virtual Programs Virtual Programs
Biologics CMC: Regulatory Challenges and Trends
Thursday, 20 January 2022 (9:00 - 4:00PM) 12.0 RAC Credits Receive an overview of chemistry, manufacturing and control (CMC) regulatory requirements and best practices associated with biologic and biosimilar products. Emphasis on requirements in the US, Europe, and other regulated regions.
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.
     
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Books Books
Risk Management Principles for Devices and Pharmaceuticals (Hardcover)
Member: $125.00 Nonmember: $175.00
Expanded and updated risk management information on healthcare products around the world.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
REMS and RMPs [3.0 RAC]
3.0 RAC Credits
Member: $365 Nonmember: $500
This course provides an overview of the history of risk management, reviews risk management philosophies and examines regulatory requirements and interactions between industry and regulators in the US, EU and Canada
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Medical Devices: Risk Management [4.0 RAC]
4.0 RAC Credits
Member: $465.00 Nonmember: $640.00
This course is intended for professionals of all experience levels interested in the techniques of risk management as applied to product safety for medical devices.
On-demand On-demand
21 CFR 820 Quality System Regulation and ISO 13485 Medical Devices
1.5 RAC Credits
Member: $0.00 Nonmember: $35.00
The RAPS Philadelphia Chapter’s webcast covering 21 CFR 820 quality system regulation and ISO 13485 medical devices.
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.
On-demand On-demand
How to Integrate Risk Management Throughout the Lifecycle of a Medical Device in the Coming Decade
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will review the application of a modern approach to risk management as a product moves through the product lifecycle.
Books Books
Complete GHTF Guidance Document Bundle
Member: $62.50 Nonmember: $82.50
A GHTF bundle of 24 guidances for medical devices: 10 from Study Group 1, eight from Study Group 2, three from Study group 3, two from Study Group 4 and one from Study Group 5.
On-demand On-demand
How to Transform Quality and Regulatory Programs from Cost Centers to Profit Centers
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
The webcast features lessons learned from the COVID-19 pandemic about leveraging risk management and quality management systems to maximize business success in times of disruption and digital transformation.