Regulatory NewsRegulatory News
Accelerated Approval: Experts weigh in on the role of RWE in confirmatory trials
Posted 08 August 2022 By Mary Ellen Schneider
As Congress considers how to reform the US Food and Drug Administration’s (FDA) controversial pathway for providing accelerated approval to drugs that treat serious or life-threatening diseases, there may be an expanded role for real-wor...
Regulatory NewsRegulatory News
Manufacturers that are not testing DSCSA data systems now are in 'big trouble'
Posted 08 August 2022 By Joanne S. Eglovitch
While much progress has been made by trading partners in implementing the pharmaceutical tracking systems called for in the Drug Supply Chain Security Act (DSCSA) more work needs to be done to ensure a smooth transition when these syst...
ReconRecon
Recon: Senate passes major drug pricing reforms; Pfizer to buy Global Blood Therapeutics for $5.4B
Posted 08 August 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
This Week at FDAThis Week at FDA
This Week at FDA: EtO, user fee woes, and product specific guidances
Posted 05 August 2022 By Ferdous Al-Faruque
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 the Environmental Protection Agency (EP...
Regulatory NewsRegulatory News
FDA announces website for complex generics
Posted 05 August 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) just launched a new webpage to share recent actions and activities related to complex generic drugs to spur their development.  
Regulatory NewsRegulatory News
Studies highlight role of US patent system in limiting competition
Posted 05 August 2022 By Mary Ellen Schneider
“The [US Patent and Trademark Office] would benefit from creating an expert unit for pharmaceutical patent examination, supported by experts from FDA, and giving patent examiners more time to review pharmaceutical patent applications,” r...
RoundupsRoundups
Euro Roundup: Industry wants clarity on links between EHDS, existing legislation
Posted 04 August 2022 By Nick Paul Taylor
MedTech Europe said “the EHDS is a pioneering initiative and has the potential to empower patients [and] accelerate the European Single Market for digital health and data by tackling barriers to cross-border data sharing.” While EHDS is ...
ReconRecon
Recon: FDA approves first interchangeable biosimilar for Lucentis eye drug; Amgen to acquire ChemoCentryx for $4 billion
Posted 04 August 2022 By Joanne S. Eglovitch
Clinical Trials, Data Security Among US Federal Enforcement Priorities  Drug promotion enforcement so far similar under new FDA chief, with just 4 letters in first half of 2022  Accelerated Assessment Dry Spell Over As EMA Says Yes T...
Chapter Events Chapter Events
Utah Chapter Webcast: ISO 13485 and the FDA QMSR
Tuesday, 09 August 2022 (1:00 - 2:00PM) 1.0 RAC Credits Member: $0 |Nonmember: $25
This session is designed to inform the attendees about the FDA’s proposed rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation.
Virtual Programs Virtual Programs
US Regulation of Advertising and Promotion for Drugs and Biologics (2022)
Thursday, 11 August 2022 (12:00 - 4:00PM) 6.0 RAC Credits Members: $580 | Nonmembers: $680
Examine requirements, guidelines, and expectations for advertising and promotion of pharmaceuticals in the US.
Virtual Programs Virtual Programs
China Drug Market Opening Up for Foreign Drug Makers
Tuesday, 16 August 2022 (11:00 - 12:30PM) 1.0 RAC Credits Member: $150 | NonMember: $175
This virtual program will provide regulatory professionals with helpful information, strategies, and insights about drug registration with China NMPA.
Chapter Events Chapter Events
Twin Cities Chapter Happy Hour
Thursday, 18 August 2022 (5:00 - 7:00PM) 0.0 RAC Credits Join us again as the RAPS Twin Cities Chapter hosts another summer Happy Hour!
Virtual Programs Virtual Programs
Sponsored Webcast: Advantages of Engaging Ahead: How Partnership & Collaboration Enable eCTD Submission Publishing Success
Wednesday, 24 August 2022 (11:00 - 12:00PM) 1.0 RAC Credits Member: $0 | NonMember: $0
Certara will demonstrate how how regulatory operations specialist were able to partner with Advaxis, Inc. to optimize regulatory operations processes.
Virtual Programs Virtual Programs
REC Webinar: Due Diligence
Friday, 09 September 2022 (4:00 - 5:15PM) 1.0 RAC Credits Learn how to approach Due Diligence with respect to acquisitions of products and intellectual property, requiring critical RA & QA/QMS competencies from both a buyers' and sellers' perspective, thereby guiding the process from both sides.
In-Person In-Person
RAPS Convergence 2022
Sunday, 11 September 2022 (8:00 - 5:00PM) 12.0 RAC Credits Members: $1,940 | Nonmembers: $2,255
Don’t Miss Regulatory’s Premiere Annual Event!
Virtual Programs Virtual Programs
Biologics CMC: Phase Appropriate Product Development
Wednesday, 28 September 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $970 | NonMember: $1150
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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Online Course Online Course
Single Certificate Single Certificate
Regulatory Affairs Certificate: Pharmaceuticals
Member: $2360.00 Nonmember: $2950.00
The Regulatory Affairs Certificate: Pharmaceuticals is achieved by completing four core and five elective courses.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Pharmaceuticals: Advertising and Promotional Labeling in the US [4.0 RAC]
4.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course outlines the regulatory framework for prescription drug and biologic promotional materials by examining FDA regulations and issues involved in producing compliant promotional materials.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Medical Devices: Advertising and Promotion in the US [3.0 RAC]
3.0 RAC Credits
Member: $365.00 Nonmember: $500.00
This course provides information regarding the primary US agencies regulating medical devices and covers their enforcement tools as well as company strategies for avoiding enforcement actions.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Regulation of Biosimilars [2.0 RAC]
2.0 RAC Credits
Member: $255.00 Nonmember: $350.00
This course is for regulatory professionals interested in biosimilar development and regulatory approval strategies.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Introduction to Regulatory Affairs in the US and Canada [2.0 RAC]
2.0 RAC Credits
Member: $255.00 Nonmember: $350.00
This course provides an overview of healthcare product regulation across product lines in North America, specifically in the US and Canada.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Introduction to Regulatory Affairs in the EU [1.0 RAC]
1.0 RAC Credits
Member: $135.00 Nonmember: $185.00
This course focuses on the development of healthcare product regulation in the European Union (EU). It discusses the responsibilities of agencies involved, processes employed and interactions among agencies.
Books Books
Terms & Definitions of Japanese Regulatory Affairs
Member: $32.50 Nonmember: $42.50
English translations of the most important Japanese regulatory terms and acronyms.
Online Course Online Course
Single Certificate Single Certificate
Regulatory Affairs Certificate: Medical Devices
Member: $2360.00 Nonmember: $2950.00
The Regulatory Affairs Certificate: Medical Devices is achieved by completing four core and five elective courses.

All Results

On-demand On-demand

Achieving Medical Device Development Success Through Early Implementation of Regulatory, Reimbursement and Clinical Research Strategies

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
Learn best practices and proven strategies to address challenges presented by today’s shifting regulatory environment and the keys to commercial success.
On-demand On-demand

Taking Advantage of the EU MDR Delay in Uncertain Times: Optimizing Your Medical Device RA/QA Strategy

1.5RAC Credits
Member: $0.00 Nonmember: $20.00
Regulatory leaders from global medical device companies will share their perspective and lessons learned regarding the challenges - both past and future - related to EU MDR.
On-demand On-demand

How to Transform Quality and Regulatory Programs from Cost Centers to Profit Centers

1.0RAC 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.
Books Books

The European In Vitro Diagnostic Regulation

Member: $295.00 Nonmember: $395.00
RAPS has teamed up with Meddev Solutions to offer a practical guide to implementing the EU IVDR.
Books Books

Introduction to the Due Diligence Process, Second Edition

Member: $75.00 Nonmember: $125.00
Explore modern elements of the due diligence process, including the changing focus of document review, and the role of regulatory counsel.
On-demand On-demand

How to Integrate Risk Management Throughout the Lifecycle of a Medical Device in the Coming Decade

1.0RAC 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

Fundamentals of EU Regulatory Affairs, Ninth Edition

Members: $295 Nonmembers: $395
Learn about the transformation of the EU healthcare product regulatory landscape, including the impact of Brexit and EMA’s move from London to Amsterdam.
On-demand On-demand

Update Your Medical Device UDI Data and Labels: This Year FDA Class I / Next Year EU MDR

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
Join speakers from Reed Tech Life Sciences and NiceLabel for an interactive webcast focused on two compliance areas they are monitoring closely.
On-demand On-demand

Are You Ready to Begin Planning your IND Submission?

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
Regulatory experts will offer advice pertaining to selecting a target indication, seeking pre-IND advice from FDA, deciding whether to use US or non-US sites for early clinical research, and more.
On-demand On-demand

The Shifting Global Regulatory Landscape: Dealing with Regulatory Affairs in an Uncertain Environment

1.0RAC Credits
Member: $0 Nonmember: $20
This webcast will not try to predict how the geopolitical world will change as a consequence of COVID-19, but will cover current hot topics and emerging challenges affecting regulatory affairs professionals globally.