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
EMA shares lessons learned from biosimilars pilot
Posted 19 October 2021 By Joanne S. Eglovitch
The lack of mature quality data, such as sufficient batch data, hindered the ability of the European Medicines Agency (EMA) to provide scientific advice to sponsors on their biosimilar development programs, according to a report on the...
Regulatory NewsRegulatory News
Cyltezo approved as interchangeable biosimilar with Humira
Posted 18 October 2021 By Kari Oakes
An anti-inflammatory biosimilar from Boehringer-Englheim has received interchangeability designation from the US Food and Drug Administration (FDA). Cyltezo (adalimumab-adbm) is now both biosimilar to and interchangeable with Abbvie’s Hu...
Regulatory NewsRegulatory News
FDA adcomm unanimous on J&J boosters for all
Posted 15 October 2021 By Kari Oakes
The vaccines advisory committee of the US Food and Drug Administration (FDA) voted unanimously Friday to recommend a full-strength booster dose of the COVID-19 vaccine made by Janssen, the vaccines arm of Johnson & Johnson, for all recip...
Regulatory NewsRegulatory News
Unanimous thumbs up from FDA committee for Moderna booster
Posted 14 October 2021 By Kari Oakes
An advisory committee to the US Food and Drug Administration (FDA) voted unanimously to recommend a half-strength booster dose of the mRNA COVID-19 developed by Moderna and the National Institutes of Health for those 65 years and older, ...
Regulatory NewsRegulatory News
FDA’s accelerated approval program: Is change on the way?
Posted 11 October 2021 By Mary Ellen Schneider
The accelerated approval program has been getting increased attention in 2021. Both the Institute for Clinical and Economic Review (ICER) and Friends of Cancer Research (FCR) issued white papers earlier this year exploring potential chan...
ReconRecon
Recon: EU says Russia delayed EMA Sputnik V inspections; FDA approves ChemoCentryx's Tavneos for rare autoimmune disease
Posted 08 October 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Feature ArticlesFeature Articles
September’s Regulatory Focus: Diversity in regulatory affairs, clinical trials, and more
Posted 07 October 2021 By Renee Matthews
Feature articles during September focused on diversity in regulatory affairs, challenges in conducting medical device clinical trials in Europe, clinical trial regulation and laws in China, and risk management in working with third-party...
Virtual Programs Virtual Programs
Biologics CMC: Phase Appropriate Product Development
Tuesday, 14 December 2021 (9:00 - 4:00PM) 12.0 RAC Credits Member: $800 Nonmember: $900 Learn how to handle technical issues affecting biologic product development challenges and expectations in the US, Europe, and other highly regulated regions.
Virtual Programs Virtual Programs
Biologics CMC: Future Trends, Current Trends and Regulatory Challenges
Tuesday, 02 November 2021 (9:00 - 4:00PM) 12.0 RAC Credits This workshop provides an overview of chemistry, manufacturing and control (CMC) regulatory requirements and best practices associated with biologic and biosimilar products, with emphasis on requirements in the US, Europe and other regulated regions.
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.
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.
Europe Europe
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Pharmaceuticals: EU Regulations [6.0 RAC]
6.0 RAC Credits
Member: $570.00 Nonmember: $790.00
This course provides an overview of the regulations and legislative framework, as well as the EMA entities responsible for medicinal product reviews.
Online Course Online Course
Europe Europe
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective
Regulation of US & EU Biologics [5.0 RAC]
4.0 RAC Credits
Member: $545.00 Nonmember: $745.00
This course examines the special characteristics of biologic products and the challenges associated with their development in the US and EU.
Books Books
Fundamentals of Pharmaceutical and Biologics Regulations, Fourth Edition (Hardcover)
Member: $295.00 Nonmember: $395.00
Bundle comprises the pharmaceutical and biologics subsets from all four Fundamentals of Regulatory Affairs books (US, EU, Canada, and international).
Books Books
Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition (Hardcover)
Member: $125 Nonmember: $175
This book presents a systematic approach to creating a global strategy to meet the requirements of multiple regulatory systems.
Books Books
Europe Europe
EU Regulatory Acronyms & Definitions, Sixth Edition (Paperback)
Member : $10.00 Nonmember: $15.00
An EU reference guide with entries in biologics, medicinal products, and medical devices.
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.
RAC Prep Bundle RAC Prep Bundle
RAC (Drugs) Prep Toolbox with Print Edition of Pharmaceutical and Biologics Fundamentals Book
Member: $1,500.00 Nonmember: $1,900.00
The Toolbox brings together a full range of valuable resources, gives you a sense for the kinds of questions you will be tested on and clarifies how the exam is structured.
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.
     
  •  
  • 1
  •  
  • 2
  •  
  • 3
  •  
  • 4
  •  
  • 5
  •  
  • 6
  •  
  •  

All Results

Europe Europe
Online Course Online Course
Pharmaceutical Certificate Elective Pharmaceutical Certificate Elective

Pharmaceuticals: EU Regulations [6.0 RAC]

6.0RAC Credits
Member: $570.00 Nonmember: $790.00
This course provides an overview of the regulations and legislative framework, as well as the EMA entities responsible for medicinal product reviews.