TrackersTrackers
COVID-19 vaccine tracker
Posted 14 January 2022 By Jeff Craven
Updated 14 January to include new information on vaccines from Pfizer/BioNTech, Moderna, AstraZeneca, Gamaleya Research Institute, Janssen Vaccines, Sinovac, Sinopharm, CanSino Biologics, Bharat Biotech/Ocugen, Center for Genetic Engin...
Regulatory NewsRegulatory News
Stakeholders seek clarity on FDA cell and gene therapy draft guidance
Posted 13 January 2022 By Jeff Craven
Industry, medical societies and other stakeholders have weighed in on draft guidance from the US Food and Drug Administration (FDA) detailing how sponsors that want to study multiple versions of cell and gene therapies could combine them...
Regulatory NewsRegulatory News
Pharmaceutical groups want more clarity on continuous manufacturing guideline
Posted 17 December 2021 By Joanne S. Eglovitch
Several industry trade associations are asking for more clarity on the International Council for Harmonisation’s (ICH) Q13 guideline on continuous manufacturing, including what constitutes a state of control for a continuous manufacturin...
Regulatory NewsRegulatory News
FDA issues final guidance on pediatric anti-infective development
Posted 13 December 2021 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) on Thursday issued a final guidance to assist sponsors in developing anti-infective drugs for the pediatric population. The guidance revises the draft version by providing more information on s...
Regulatory NewsRegulatory News
FDA issues final guidance on CMC postapproval changes for annual reports
Posted 09 December 2021 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) on Thursday issued a final guidance to help manufacturers of certain biological products determine which types of changes to their products should be submitted in annual reports for changes exp...
ReconRecon
Recon: FDA advisors narrowly back Merck’s COVID drug; Sanofi to buy Origimm for its acne vaccine candidate
Posted 01 December 2021 By Michael Mezher
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
Public-private initiative expands support for NGS tests
Posted 30 November 2021 By Kari Oakes
A key microbial genome database is being updated and expanded through a public-private partnership, as the US Food and Drug Administration (FDA) works with a health data company and an academic institution to build out the FDA-ARGOS data...
Regulatory NewsRegulatory News
FDA offers draft guidance for registries as RWD
Posted 29 November 2021 By Mary Ellen Schneider
The US Food and Drug Administration (FDA) released draft guidance on the use of registries in regulatory decision making, adding another piece to the puzzle of how the agency will consider real-world data (RWD) when considering a new dru...
Virtual Programs Virtual Programs
Preparing to Take the RAC Drugs Exam
Tuesday, 08 February 2022 (11:00 - 4:00PM) 12.0 RAC Credits Members: $970 |Non-members: $1,150
Designed specifically for those preparing to take the RAC Drugs exam, workshop will be facilitated by a panel of RAC-certified regulatory professionals and focuses on sharpening strategic test-taking skills.
Virtual Programs Virtual Programs
Biologics CMC: Phase Appropriate Product Development
Thursday, 17 March 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $825 | Nonmember: $970
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: Phase Appropriate Product Development
Thursday, 21 July 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $825 Nonmember: $970
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: Phase Appropriate Product Development
Thursday, 08 December 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $825 | Non-member: $970
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
COVID-19 In Vitro Diagnostics: A Look into FDA’s Regulatory Response
Thursday, 10 February 2022 (1:00 - 2:00PM) 1.0 RAC Credits Members $0 | Nonmenbers $0 This presentation will discuss the FDA Emergency Use Authorization Guideline and how the guidance has changed over time.
Virtual Programs Virtual Programs
US Regulatory Essentials, Pharmaceuticals
Monday, 28 February 2022 (9:00 - 5:30PM) 6.0 RAC Credits Member: $495 |Nonmember: $580
An overview of laws, regulations and guidance affecting US regulation of biologics and pharmaceutical products, this workshop is for new -intermediate level professionals and those preparing for the RAC Drugs exam
Virtual Programs Virtual Programs
Biologics CMC: Regulatory Challenges and Trends
Thursday, 19 May 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $825|Nonmember: $970
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 regulated regions.
RAC Exam RAC Exam
RAC Drugs Examination Autumn 2022
Member: $490.00 Nonmember: $615.00
Testing Window :
31 October 2022 To 9 December 2022
RAC Exam RAC Exam
RAC Drugs Examination Spring 2022
Member: $490.00 Nonmember: $615.00
Testing Window : 21 March 2022 To 29 April 2022
RAC Exam RAC Exam
RAC Drugs Examination Summer 2022
Member: $490.00 Nonmember: $615.00
Testing Window : 11 July 2022 To 19 August 2022
Books Books
Fundamentals of International Regulatory Affairs, Fifth Edition
Members: $295 Nonmembers: $395
This edition discusses regulatory changes that have occurred globally and technologically with a focus on drugs and medical devices.
Online Course Online Course
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.
On-demand On-demand
FDA Forecast: What’s Next for the FDA in 2022? (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $0
In this webcast, AgencyIQ’s regulatory intelligence team will explore the top regulatory issues and challengers they expect the FDA and life sciences industry to encounter next year.
On-demand On-demand
US Regulation of Advertising and Promotion of Drugs
6.0 RAC Credits
Member: $399.00 Nonmember: $499.00
Examine the current requirements for advertising and promotion of healthcare products in the US, and how they impact the way you communication with healthcare professionals, consumers and managed care audiences
On-demand On-demand
China NMPA (CFDA) Regulatory Approval: Clinical Evaluation and Pathways
6.0 RAC Credits
Member: $480.00 Nonmember: $540.00
This workshop will cover different clinical evaluation and pathways and how to decide which pathway to choose to support China NMPA medical device/IVD regulatory approval or postmarket study requirements.
     
  •  
  • 1
  •  
  • 2
  •  
  •  

All Results

RAC Exam RAC Exam

RAC Drugs Examination Autumn 2022

Member: $490.00 Nonmember: $615.00
Testing Window :
31 October 2022 To 9 December 2022
RAC Exam RAC Exam

RAC Drugs Examination Spring 2022

Member: $490.00 Nonmember: $615.00
Testing Window : 21 March 2022 To 29 April 2022
RAC Exam RAC Exam

RAC Drugs Examination Summer 2022

Member: $490.00 Nonmember: $615.00
Testing Window : 11 July 2022 To 19 August 2022