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Starting Friday, 26 November, save 20% on all books, e-books, RAPS Online University Certificate Programs and individual online courses now through Monday with discount code CYBERMONDAY20*.
Become a RAPS member or renew your membership between 26–29 November and receive a complimentary e-book of your choosing (up to a $175 value).
Looking to hire regulatory professionals? Save 20% on any job posting with code CYBERMONDAY20Post a job »
ReconRecon
Recon: Califf nomination timeline slips after Biden admin misses paperwork deadline; Canada fully approves J&J COVID vaccine
Posted 24 November 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
RoundupsRoundups
FDA Approvals Roundup: Voxzogo, Fyarro, Livtencity
Posted 24 November 2021 By Renee Matthews
A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
Regulatory NewsRegulatory News
Smiths Medical warned by FDA for multiple violations
Posted 24 November 2021 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) slapped Smiths Medical in Minneapolis, MN with a warning letter for inadequate procedures for handling medical device reports (MDRs), faulty handling of complaints, inadequate validation proces...
Regulatory NewsRegulatory News
FDA suggests alternative approaches for nitrosamine risk assessments
Posted 23 November 2021 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) has suggested that manufacturers consider using certain antioxidants or excipients, such as sodium carbonate, to their drug products to inhibit the formation of nitrosamine impurities.  
Regulatory NewsRegulatory News
FDA shares research to improve dose selection in pediatric drug development
Posted 23 November 2021 By Mary Ellen Schneider
In a Regulatory Science in Action article, scientists from the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) shared findings about how adjustments to the estimated glomerular filtration rate (eGFR) equa...
RoundupsRoundups
Asia-Pacific Roundup: TGA changes medicinal cannabis approval process, plans further reforms
Posted 23 November 2021 By Nick Paul Taylor
The Therapeutic Goods Administration (TGA) has revised the process for applying to supply medicinal cannabis products under Australia’s Special Access Scheme (SAS) and Authorised Prescriber scheme. TGA made the changes after holding a co...
ReconRecon
Recon: Global license deal to provide COVID antibody test tech free to poorer countries; GSK partners with Arrowhead for NASH drug
Posted 23 November 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
FDA says it far exceeded its projections for inspections in FY2021
Posted 22 November 2021 By Michael Mezher
In an update to its Resiliency Roadmap for FDA Inspectional Oversight , the US Food and Drug Administration (FDA) on Monday said that the number of domestic surveillance inspections it carried out in the second half of FY2021 was more t...
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
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 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: Future Trends, Current Trends and Regulatory Challenges
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: Future Trends, Current Trends and Regulatory Challenges
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
In-Person In-Person
Biologics CMC: Future Trends, Current Trends and Regulatory Challenges
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
Virtual Programs Virtual Programs
Sponsored Webcast: The Evolving Regulatory Real-World Evidence Landscape: Understanding FDA's 2021 RWE Guidance
Thursday, 09 December 2021 (10:00 - 11:30AM) 1.0 RAC Credits Member: $0 NonMember: $0
Join a discussion on FDA’s RWE guidance landscape, including how new draft guidance fits into the current ecosystem and implications for biopharma organizations as they develop evidence generation strategies.
     
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On-demand On-demand
IVDR 2022: What IVD manufacturers can learn from the MDR rollout
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will clarify the terminology and concepts under the umbrella term Artificial Intelligence and how it differs from standard software.
On-demand On-demand
Artificial Intelligence: A Regulatory Perspective
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will clarify the terminology and concepts under the umbrella term Artificial Intelligence and how it differs from standard software.
On-demand On-demand
The Aftermath of MDR
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will clarify the terminology and concepts under the umbrella term Artificial Intelligence and how it differs from standard software.
On-demand On-demand
Three Real-World Experiences Using a Novel Data Platform
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will clarify the terminology and concepts under the umbrella term Artificial Intelligence and how it differs from standard software.
On-demand On-demand
China NMPA Clinical Evaluation and Trial Key Changes to Support Order 739 Webcast
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will clarify the terminology and concepts under the umbrella term Artificial Intelligence and how it differs from standard software.
Books Books
The Medical Device Validation Handbook, Second Edition (Hardcover)
Member: $125.00 Nonmember: $175.00
The handbook covers device validation and revalidation throughout the product lifecycle, from design through postmarket.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Good Clinical Practice (GCP) [2.0 RAC]
2.0 RAC Credits
Member: $255.00 Nonmember: $350.00
This course identifies the regulations on the proper conduct of clinical research with human subjects that were put in place due to ethical issues in human research.
On-demand On-demand
SaMD Product Development: Addressing Challenges through Early Integration of Regulatory, Quality and Clinical Data Strategies
Member: $0.00 Nonmember: $20.00
This webcast will focus on best practices and proven strategies to address challenges presented by today’s shifting SaMD regulatory environment, and discuss the keys to commercial success.

* RAPS Cyber Monday sale begins at 12:01 am on Friday, 26 November and ends at 11:59 PM EST on Monday, 29 November 2021. Offer may not be combined with any other promotions or discounts and may not be applied to prior purchases. 20% off promotion EXCLUDES RAPS Executive Development Program, RAC exam registration, RAC toolboxes, RAC prep bundles, individual RAC prep materials, RAPS Convergence, RAPS Euro Convergence, and RAPS live virtual programs.

Instructions for redeeming the promotional e-book offered with RAPS memberships and renewals purchased during the Cyber Monday sale will be included in the purchase receipt. This promotion is valid for a one-time download of an e-book valued up to $175 and expires at 11:59 PM EST on 31 December 2021.

Have questions? Please contact the RAPS solutions center by email at support@raps.org or by calling 301-770-2920 extension 200.