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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...
Chapter Events Chapter Events
RAPS Switzerland Chapter Event - Global Medtech Reimbursement Round Table
Tuesday, 30 November 2021 (3:00 - 5:30PM) 0.0 RAC Credits Members: $0 Nonmembers: $0
Hear from Payers, Providers and MedTech stakeholders for a discussion and exploration on global reimbursement and market access strategies. This is a free webcast hosted by the RAPS Switzerland chapter.
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.
Chapter Events Chapter Events
New York/New Jersey Chapter Webcast: PDUFA VII
Thursday, 02 December 2021 (12:00 - 1:00PM) 1.0 RAC Credits Member: $10 Nonmember: $25
Learn about the soon reauthorized Prescription Drug User Fee Act (PDUFA VII) changes and what it means for the pharmaceutical and biopharmaceutical industries.
Chapter Events Chapter Events
Atlanta Chapter: Annual Breakfast with the Atlanta Southeast FDA District Office
Friday, 03 December 2021 (9:00 - 11:00AM) 2.0 RAC Credits Member: $10 Nonmember: $25
Join us for a virtual breakfast to engage with the Atlanta Southeast FDA District Office representatives and get your hard-pressed questions answered.
Virtual Programs Virtual Programs
Meet the Authors: Global Pediatric Development of Drugs, Biologics, and Medical Devices
Monday, 06 December 2021 (10:00 - 11:00AM) 0.0 RAC Credits Member: $0 NonMember: $0
Four authors from the latest RAPS book, Global Pediatric Development of Drugs, Biologics, and Medical Devices, will be on hand to answer all your burning questions on global pediatric development in regulatory affairs.
Virtual Programs Virtual Programs
Rollout IVDR 2022: What can IVD manufacturers learn from the MDR rollout when establishing compliance for their IVD devices by May 2022?
Tuesday, 07 December 2021 (10:00 - 11:30AM) 1.0 RAC Credits Fee: $0
This webcast will cover the potential impact of IVDR implementation in 2022 for new and existing (legacy) devices and considerations learned from the MDR rollout for IVD manufacturers to consider when determining regulatory strategy
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.
Virtual Programs Virtual Programs
FDA Forecast: What’s Next for the FDA in 2022?
Thursday, 09 December 2021 (12:00 - 1:30PM) 1.5 RAC Credits Member: $0 NonMember: $0
In this webcast, AgencyIQ’s regulatory intelligence team will explore the top regulatory issues and challengers they expect the FDA and life sciences industry to encounter next year.
     
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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
Combination Products: Regulatory Approach and cGMP Requirements (On-demand)
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webinar will walk you through the regulatory approach and the new regulations applied for combination products.
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
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
Combination Products: Regulatory Approach and cGMP Requirements
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Language service providers can help pharmaceutical companies navigate CTD submissions required by recent regulatory changes in APAC countries such as China.
On-demand On-demand
Understanding Key Components of a Clinical Evaluation
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This broadcast will explain the key changes of clinical evaluation, review phases for clinical evaluation, explain expectations for systematic literature review, and identify types of clinical support data.
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.

All Results

On-demand On-demand

IVDR 2022: What IVD manufacturers can learn from the MDR rollout

1.0RAC 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

Combination Products: Regulatory Approach and cGMP Requirements (On-demand)

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
This webinar will walk you through the regulatory approach and the new regulations applied for combination products.
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

Artificial Intelligence: A Regulatory Perspective

1.0RAC 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

Combination Products: Regulatory Approach and cGMP Requirements

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
Language service providers can help pharmaceutical companies navigate CTD submissions required by recent regulatory changes in APAC countries such as China.
On-demand On-demand

Understanding Key Components of a Clinical Evaluation

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
This broadcast will explain the key changes of clinical evaluation, review phases for clinical evaluation, explain expectations for systematic literature review, and identify types of clinical support data.
On-demand On-demand

The Aftermath of MDR

1.0RAC 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

1.0RAC 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

How Huvepharma Maintains Quality and Innovation in a High Growth Environment

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
Learn the need-to-know information for providing your promotional materials submissions in the eCTD format.
On-demand On-demand

China NMPA Clinical Evaluation and Trial Key Changes to Support Order 739 Webcast

1.0RAC 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.

* 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.