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...
RAPS' LatestRAPS' Latest
RAPS AnnouncementsRAPS Announcements
FDA commissioner Robert Califf to speak at RAPS Convergence 2022
Posted 04 August 2022 By Ryan Connors
After holding two years of virtual conferences, Convergence will commence its return to an in-person meeting with an opening plenary session where Califf will present on 11 September at 4:30 pm MDT. The commissioner will provide his r...
Regulatory NewsRegulatory News
EPA lists potentially high-risk EtO plants, plans to finally publish air pollution rule by year’s end
Posted 03 August 2022 By Ferdous Al-Faruque
The US Environmental Protection Agency (EPA) has published a list of ethylene oxide (EtO) sterilization plants around the country that may be linked to increased cases of cancer in nearby communities. The agency also plans to publish a...
Regulatory NewsRegulatory News
EMA reports slow uptick in clinical trial applications submitted via CTIS portal
Posted 03 August 2022 By Joanne S. Eglovitch
The number of applications filed through the Clinical Trial Information System (CTIS) portal continues to grow, even while most applications are still being filed in the current EudraCT system, according to a 29 July report from the Eu...
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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On-demand On-demand
Sponsored Webcast: Why UDI is a Regulatory Issue and Not Just an Operational Process (On-Demand)
1.0 RAC Credits
Members: $0 | Nonmembers: $25
Simplify UDI complexity by exploring requirements across several major markets, including the types of devices that are covered and the expected implementation timelines.
On-demand On-demand
COVID-19 EUAs: The Beginning of the End
1.5 RAC Credits
Member: $0 NonMember: $25
The authors of RAPS new regulatory reference guide, Orphan Drug Development for Rare Diseases, will be on hand to discuss every aspect of orphan drug development.
On-demand On-demand
Sponsored Webcast: Early Clinical, CMC, and Device Development Considerations Unique to Cellular and Gene Therapy Products (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $25
This webcast will cover the development and regulatory process for new therapeutics, proven strategies that help reduce risk of failure, and how to streamline clinical development and increase speed to market.
On-demand On-demand
On-demand Webcast: E-labeling and Legislation: A Positive Impact on Patient Safety and Sustainability
1.0 RAC Credits
Member: $0 NonMember: $25
The authors of RAPS new regulatory reference guide, Orphan Drug Development for Rare Diseases, will be on hand to discuss every aspect of orphan drug development.
RAC Prep Bundle RAC Prep Bundle
RAC (Drugs) Flashcards
Member: $40.00 Nonmember: $50.00
Study drug terminology at your fingertips in an easy-to-use flashcard format.
RAC Prep Bundle RAC Prep Bundle
RAC (Devices) Flashcards
Member: $40.00 Nonmember: $50.00
Study devices terminology at your fingertips in an easy-to-use flashcard format.
On-demand On-demand
COVID-19 In Vitro Diagnostics: A Look into FDA’s Regulatory Response
1.0 RAC Credits
Member: $0 NonMember: $25
This presentation will discuss the FDA Emergency Use Authorization Guideline and how the guidance has changed over time.
On-demand On-demand
Meet the Authors: Orphan Drug Development for Rare Diseases
1.0 RAC Credits
Price: $0
The authors of RAPS new regulatory reference guide, Orphan Drug Development for Rare Diseases, will be on hand to discuss every aspect of orphan drug development.

All Results

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PMS Requirements of the EU MDR: Implementation Challenges and Solutions

1.5RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will go into detail about strategies to overcome audit findings and gaps in your evidence.
On-demand On-demand

China NMPA & US FDA Emergency Approval – Implications to Life Science Companies Relating to COVID-19

1.5RAC Credits
Member: $0.00 Nonmember: $20.00
Our experts will explain related guidelines, emergency approval procedures, urgent importations, how they work in practice, what is required during the COVID-19 crisis, and what to expect moving forward.
On-demand On-demand

Best Practices for Building An Efficient Literature Review Process

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will review simple, pragmatic approaches and tools to focus on the high value work of CER preparation by reducing the time to complete low value administrative tasks.
Books Books

Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition

Member: $160.00 Nonmember: $225.00
This book presents a systematic approach to creating a global strategy to meet the requirements of multiple regulatory systems.
On-demand On-demand

Strategic Role of the RA Professional

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will demonstrate how the RA professional is a key strategic player starting with premarket planning and continuing through product development stages, manufacturing, and post market activities.
On-demand On-demand

EU MDR Prep: Translation Requirements That Will Make or Break Your Devices In Europe

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
The presenters will outline essential information and considerations for device manufacturers across the EU and explain everything you need to do to remain compliant.
On-demand On-demand

AI for Post Market Surveillance Compliance and Regulatory Work According to MDR

1.5RAC Credits
Member: $0.00 Nonmember: $20.00
Webcast registration includes access to handouts, presentation slides and the on-demand recording for one year.
RAC Prep Bundle RAC Prep Bundle

RAC (Drugs) Reference Package: Basic

Member: $400 Nonmember: $525
Purchase the Fundamentals of Medical Device Regulations book, RAC (Device) Practice Test and Flashcards together and save on these indispensable reference tools—our most popular products to help you prepare.
RAC Prep Bundle RAC Prep Bundle

RAC (Devices) Reference Package: Basic

Member: $400 Nonmember: $525
Purchase the Fundamentals of Medical Device Regulations book, RAC (Devices) Flashcards and Practice Test together and save on these indispensable reference tools—our most popular products to help you prepare.
Books Books

Essentials of Healthcare Product Labeling

Member: $130.00 Nonmember: $180.00
Learn details on labeling for the full lifecycle of human healthcare products, from target labeling through submission and marketing in the US, EU and Canada.