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...
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 ...
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, HMA outline evolution of DARWIN EU real-world database
Posted 02 August 2022 By Ferdous Al-Faruque
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) plan to launch an ambitious new database to collect real-world data (RWD) from a slew of studies that reviewers can reference for their regulatory decision-mak...
Combination Products Summit 2022
Monday, 07 November 2022 (8:30 - 5:00PM) 0.0 RAC Credits Since 2015, the Combination Products Summit has united the healthcare products industry to work for a better tomorrow.
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
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
Europe Europe
Regulatory Leadership
Tuesday, 18 October 2022 (9:00 - 5:00PM) 0.0 RAC Credits Members: €1080 | Nonmembers: €1265
Learn the typical career routes you can take as a Regulatory professional. This workshop will increase your awareness of what leadership means, particularly when it comes to Regulatory and Quality.
Chapter Events Chapter Events
San Francisco Chapter Webcast: Cannabis: Where Are We Now?
Tuesday, 04 October 2022 (10:00 - 11:30AM) 1.5 RAC Credits Member: $0 |Nonmember: $25
This webcast will describe the terminology, and differences between FDA-approved and non-FDA approved cannabis, as well as an overview of current regulations of cannabis based products
PharmaLink 2022
Tuesday, 15 November 2022 (8:30 - 5:00PM) 0.0 RAC Credits Don’t miss this opportunity to join your colleagues and global regulators from around the world so you can make a meaningful difference for your organization, and our industry, and most importantly, the patients.
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.
In-Person In-Person
Biologics CMC: Regulatory Challenges and Trends
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
     
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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
2021 China NMPA (CFDA) Key Updates and 2022 Forecast (On-Demand)
1.0 RAC 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
Meet the Authors, Regulatory Writing, Second Edition
1.0 RAC Credits
Member: $0.00 Nonmember: $0.00
Hear from the experts who wrote the book on regulatory writing. Authors Lisa DeTora, Jocelyn Jennings and Jenny Grodberg will discuss the new edition’s writers-eye view of regulatory documentation.
On-demand On-demand
Sponsored Webcast: FDA QMSR: What do the Proposed Changes Mean for Industry?
1.0 RAC Credits
Member: $0 | NonMember: $25
Speakers will review the history of quality systems, look at the changes to quality regulations and discuss the FDA’s intent to adopt the ISO 13485 standard.
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
Artificial Intelligence: A Regulatory Perspective (On Demand)
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will provide an overview of terminology and concepts in Artificial Intelligence, review the regulatory requirements in the EU market, cover real-world examples of commercial solutions
On-demand On-demand
Most Common Findings in EU Clinical Evaluations
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn the most common findings identified by Notified Bodies and by Qserve when performing a final CER review to the requirements of the MDR and MEDDEV 2.7/1 rev.4.