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
Driving Innovation: Planning for CTD Submissions with Language Excellence
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
Regulatory Policy & Intelligence: Understanding When, Why, and How to Invest in Growing These Capabilities
1.0 RAC Credits
Member: $0 Nonmember: $20
Industry-leading regulatory experts will provide practical insights on how to assess RI needs, why this area is worth the investment, and how to build an RI strategy that fortifies the unique objectives of your company.
On-demand On-demand
Navigating Today’s Regulatory Trends to Successfully Manage eCTD Submissions
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will feature an overview of best practices to create successful eCTD submissions in a rapidly changing environment.
On-demand On-demand
Building Global Submissions from the Ground Up - SARS-CoV-2 Case Study
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Whether you are developing SARS-CoV-2 assays or are just interested how to efficiently build your global submissions, this webcast aims to share some of those best practices using SARS-CoV-2 as a case study.
On-demand On-demand
Stay on Track and Get Some Sleep: Marketing Application Best Practices
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Regulatory experts will offer tips and guidance for acceleration, submission leadership, and regulatory strategy from that you can apply to your marketing application to help ensure a successful submission.
Books Books
Global Medical Device Regulatory Strategy, Second Edition
Member: $205.00 Nonmember: $285.00
Learn to develop a comprehensive global regulatory strategy for medical devices, labeling, clinical, risk management, marketing, and postmarketing.
On-demand On-demand
Effective Labeling Management Requires a New Mindset : A Strategic Guide to Labeling Process Optimization
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will review the best methods to evaluate factors that could affect product labeling management.
On-demand On-demand
Strategies for Successful PMCF Planning and Execution
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Walks you through a clear process for ensuring your PMCF planning is effective and efficient, beginning with an overview of what's required and how to evaluate your current state against the requirements.

All Results

On-demand On-demand

Meet the Authors: Regulation of Regenerative Medicine: A Global Perspective

1.0RAC Credits
Price: $0
Hear from the authors who wrote RAPS' latest book, Regulation of Regenerative Medicine: A Global Perspective. Regenerative medicine is a growing field with more countries focused on generating governing regulations.
On-demand On-demand

Sponsored Webcast: What is FDA's Project Optimus and How Will it Impact Oncology Drug Development? (On-Demand)

1.0RAC Credits
Member: $0 NonMember: $25
This webinar will provide information on FDA’s Project Optimus and its potential impacts on oncology drug development.
On-demand On-demand

Sponsored Webcast: Building Compliance with an Electronic Quality Management System (On-Demand)

1.5RAC Credits
Member: $0 NonMember: $25
Learn to leverage electronic QMS systems to build compliance. This live broadcast will debunk QMS myths and address the challenges in ensuring data integrity.
On-demand On-demand

2021 China NMPA (CFDA) Key Updates and 2022 Forecast (On-Demand)

1.0RAC Credits
Members: $0 | Nonmembers: $25
This webcast will show how manufacturers can expedite the path to market for new China NMPA submissions. It will cover Order 739, when to file for modifications, how to keep medical devices compliant, and more.
Books Books

Regulation of Regenerative Medicines: A Global Perspective

Member: $145.00 Nonmember: $200.00
Regulation of Regenerative Medicines: A Global Perspective takes a look inside the rapidly evolving cell therapy, gene therapy, and tissue engineering landscape in the US and other key world markets.
On-demand On-demand

Sponsored Webcast: eCTD Submission Challenges (On-Demand)

1.0RAC Credits
Members: $0 | Nonmembers: $25
Regulatory operations specialist Joshua Lett will explore how challenges in eCTD submissions may provide opportunities for personal and professional growth.
On-demand On-demand

Sponsored Webcast: Why UDI is a Regulatory Issue and Not Just an Operational Process (On-Demand)

1.0RAC 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

1.5RAC 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)

1.0RAC 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

1.0RAC 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.