RoundupsRoundups
Euro Roundup: EMA seeks feedback on framework for incorporating patient views into regulatory decisions
Posted 21 October 2021 By Nick Paul Taylor
The European Medicines Agency (EMA) has reached a draft qualification opinion on a framework for incorporating patient views into regulatory decisions. The agency “generally endorsed” the proposed research framework and is now seeking fe...
ReconRecon
Recon: CDC panel meets on Moderna, J&J boosters, 'mix and match'; FDA issues refuse-to-file letter for Stealth's Barth syndrome drug
Posted 21 October 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
FDA chastises three US firms for ignoring record requests, inadequate CMO oversight, and shoddy response to fires
Posted 21 October 2021 By Joanne S. Eglovitch
Inadequate oversight of contract manufacturers, failing to address how a fire affected the quality of active pharmaceutical ingredients, and ignoring the agency’s request for electronic records prompted the US Food and Drug Administratio...
Regulatory NewsRegulatory News
FDA okays Moderna, J&J, 'mix and match' boosters
Posted 20 October 2021 By Kari Oakes
The US Food and Drug Administration has authorized booster doses of both the Moderna COVID-19 vaccine and the vaccine made by Janssen, the vaccines arm of Johnson & Johnson. The agency has also taken a “mix and match” approach, authorizi...
Regulatory NewsRegulatory News
Consent decree shuts down Utah herbal firm
Posted 20 October 2021 By Kari Oakes
The filing came after FDA issued a 2017 warning letter to the supplement manufacturer, which then continued marketing and selling its products with claims that made them unapproved and misbranded drugs, rather than the dietary suppleme...
ReconRecon
Recon: Novavax falls on reports of production delays; Biogen's Aduhelm sales fall well below expectations
Posted 20 October 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
FDA issues proposed OTC hearing aid rule
Posted 19 October 2021 By Jeff Craven
The US Food and Drug Administration (FDA) has issued a long-awaited proposed rule to create a new regulatory category that would allow the sale of over-the-counter (OTC) hearing aids for adults with mild and moderate hearing loss.
Virtual Programs Virtual Programs
Getting a Seat at the Table: Optimizing the Role of the Regulatory Professional
Friday, 05 November 2021 (1:00 - 2:30PM) 1.5 RAC Credits Member $160 Nonmember $175 Learn how to run an effective regulatory team and how to get your colleagues to work with you and not against you.
Virtual Programs Virtual Programs
Sponsored Webcast: Three Real-World Experiences Using a Novel Data Platform
Tuesday, 26 October 2021 (12:00 - 1:30PM) 1.0 RAC Credits Member: $0 NonMember $0 This program will give you practical insights into new approaches and tools to help manage your business. It will cover 510(k) submission strategy, product code policy assessment, and postmarket safety analysis.
Virtual Programs Virtual Programs
Sponsored Webcast: How Huvepharma Maintains Quality and Innovation in a High Growth Environment
Thursday, 04 November 2021 (12:00 - 1:00PM) 1.0 RAC Credits Member: $0 Non Member: $0 Experts from a leading global provider of animal health and nutrition products, Huvepharma, will explain how a flexible Quality Management System (QMS) has a played a crucial role in their business success.
Virtual Programs Virtual Programs
China NMPA Clinical Evaluation and Trial Key Changes to Support Order 739 Webcast
Thursday, 28 October 2021 (10:00 - 11:15AM) 1.5 RAC Credits This webcast will explore the evolving regulations for China NMPA, reviewing regulations related to clinical evaluation, the main changes under Decree #739 in areas of clinical evaluation pathways, clinical evaluation principles and data appraisals.
Virtual Programs Virtual Programs
US Regulatory Essentials, Pharmaceuticals
Wednesday, 17 November 2021 (9:00 - 5:30PM) 6.0 RAC Credits An overview of laws, regulations and guidance affecting US regulation of biologics and pharmaceutical products, this workshop is tailored for new to intermediate level professionals and those preparing for the RAC Drugs examination.
Virtual Programs Virtual Programs
Business Writing in Regulatory Settings
Tuesday, 09 November 2021 (6:00 - 7:30AM) 1.5 RAC Credits Member: $160 Nonmember: $175 Learn to write documents in a clear and well‐organized manner under short deadlines, that are correct, complete and concise. *Global Time Zones* 06:00 (Washington, DC) / 12:00 pm (Brussels) / 18:00 (Hong Kong)
Virtual Programs Virtual Programs
Expedited Pathways (US/Global) – Medical Device
Monday, 15 November 2021 (8:30 - 4:15PM) 12.0 RAC Credits Led by a veteran regulatory manager, this workshop will focus on expedited pathways by FDA, EU, China NMPA and other regulatory agencies from major global markets as to map out a pathway to bring products to market as fast as possible.
Chapter Events Chapter Events
New York/New Jersey Chapter Webcast: Regulatory Considerations for Gene Therapy Development
Thursday, 18 November 2021 (12:00 - 1:00PM) 1.0 RAC Credits Member: $10 Nonmember: $25 Explore the different regulatory pathways exclusive to gene therapies within the larger area of regenerative medicine.
     
  •  
  • 1
  •  
  • 2
  •  
  •  
On-demand On-demand
CMC - An Integral Component of Cell and Gene Therapy Development
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Experts from Cardinal Health Regulatory Sciences discuss CMC challenges and potential mitigation strategies illustrated through multiple case studies.
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.
Books Books
Fundamentals of Canadian Pharmaceutical, Biologic and Medical Devices Regulations (Hardcover)
Member: $100.00 Nonmember: $150.00
A compilation of Fundamentals of Canadian Pharmaceutical and Biologics Regulations and Fundamentals of Canadian Medical Device Regulations.
Product Bundle Product Bundle
Regulatory Basics Bundle - US & Canada
Member: $400.00 Nonmember: $560.00
This bundle provides fundamental information on product lifecycles, gives insight into professional roles and responsibilities and discusses regulatory mechanisms, processes and agencies within key markets.
Books Books
Software as a Medical Device (Paperback)
Member: $125.00 Nonmember: $175.00
SaMD will help readers uncover whether their software is subject to global medical device regulations, understand the regulatory implications, and develop their SaMD strategy.
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Pharmaceuticals: Canadian Regulations [6.0 RAC]
6.0 RAC Credits
Member: $570.00 Nonmember: $790.00
This course will introduce you to essential areas of regulatory knowledge for a broad range of pharmaceutical, radiopharmaceutical and biologic products in Canada.
Books Books
Regulatory Intelligence 101, Third Edition (Paperback)
Member: $125.00 Nonmember: $175.00
Comprised of 25 chapters from 30 experts from seven different countries, this new edition incorporates a global overview of regulatory intelligence.
Product Bundle Product Bundle
Regulatory Basics Bundle - Complete
Member: $500.00 Nonmember: $700.00
This bundle provides fundamental information on product lifecycles, gives insight into professional roles and responsibilities and discusses regulatory mechanisms, processes and agencies within key markets.