Regulatory NewsRegulatory News
Continuous manufacturing applicants saw quicker approvals, higher revenue than batch applicants
Posted 06 July 2022 By Jeff Craven
Applicants that used continuous manufacturing (CM) technology to bring their products to market waited less time before approval after submission compared to batch manufacturing products, according to results from a US Food and Drug Admi...
Regulatory NewsRegulatory News
European Commission adopts common specifications for high-risk IVDs
Posted 06 July 2022 By Michael Mezher
The European Commission on Monday issued a regulation that establishes common specifications certain high-risk in vitro diagnostics (IVD), which are a critical component of the In Vitro Diagnostic Regulation (IVDR).
Regulatory NewsRegulatory News
Health policy experts call for stronger accelerated approval reforms
Posted 06 July 2022 By Mary Ellen Schneider
The US Congress should take concerns raised by the Food and Drug Administration (FDA) seriously and give the agency more authority around accelerated approvals, including the power to expedite the withdrawal of drugs from the market, acc...
ReconRecon
Recon: FDA grants priority review for Biogen-Eisai’s Alzheimer’s drug; Senate Democrats advance drug-price deal
Posted 06 July 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Regulatory NewsRegulatory News
FDA publishes two critical DSCSA draft guidances
Posted 05 July 2022 By Joanne S. Eglovitch
The US Food and Drug Administration (FDA) on 5 July issued two draft guidances covering the implementation of the Drug Supply Chain Security Act (DSCSA); one addresses the use of electronic standards for tracing products through the ph...
ReconRecon
Recon: FDA reconvenes adcomm meeting for Amylyx’s Pharma’s ALS treatment; AstraZeneca growing lymphoma pipeline with $1.3B TeneoTwo acquisition
Posted 05 July 2022 By Joanne S. Eglovitch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
RoundupsRoundups
Asia-Pacific Roundup: TGA updates uniform recall procedure
Posted 05 July 2022 By Nick Paul Taylor
Two key changes highlight the updated version 2.3 of the uniform recall procedure from Australia’s Therapeutic Goods Administration (TGA) – the removal of a section on crisis management guidelines and the addition of details on what the ...
This Week at FDAThis Week at FDA
This Week at FDA: User fee timeline, bivalent boosters, and more
Posted 01 July 2022 By Michael Mezher
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. The biggest news out of FDA this week was the ag...
Virtual Programs Virtual Programs
Biologics CMC: Phase Appropriate Product Development
Thursday, 21 July 2022 (9:00 - 4:00PM) 12.0 RAC Credits Member: $970 | Nonmember: $1,150
Learn how to handle technical issues affecting biologic product development challenges and expectations in the US, Europe, and other highly regulated regions.
Chapter Events Chapter Events
Ontario Chapter Webcast: What, Why and When of Postmarket Clinical Follow-up
Thursday, 21 July 2022 (12:00 - 1:00PM) 1.0 RAC Credits PMCF is now an expectation for many medical devices. As the expectations for EU MDR become clear, PMCF can still be confusing. We will review what may qualify for PMCF, what is required, and when it is required.
Virtual Programs Virtual Programs
Root Cause Investigation for CAPA
Tuesday, 26 July 2022 (11:00 - 3:00PM) 12.0 RAC Credits Member: $970| Nonmember: $1150
Investigative tools used to identify technical root causes, systemic root causes, corrective and preventive actions, and control plans to monitor and prevent recurrence.
Chapter Events Chapter Events
Indiana Chapter Webcast: Challenges and Lessons Learned from Both an Industry and Notified Body Perspective for the Implementation of EU Regulations
Tuesday, 26 July 2022 (3:30 - 5:00PM) 1.5 RAC Credits Member: $0 NonMember: $25
Join regulatory professionals for an overview of key learnings obtained on the journey to MDR and IVDR certification.
Virtual Programs Virtual Programs
Sponsored Webcast: FDA QMSR: What do the Proposed Changes Mean for Industry?
Wednesday, 03 August 2022 (10:00 - 11:00AM) 1.0 RAC Credits Member: $0 | NonMember: $0
In this webcast, experts 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.
Virtual Programs Virtual Programs
Tackling the CMC Challenges for Cell and Gene Therapy Product Development
Wednesday, 03 August 2022 (12:00 - 2:00PM) 2.0 RAC Credits Price: Member: $195 / Nonmember $230
Key opinion leaders from academia, industry, and a regulatory agency will discuss these strategies in addressing CGT manufacturing challenges to bring transformative medicines to patients.
Virtual Programs Virtual Programs
Setting the Standard for Real-World Evidence: Research Methods and Data Quality for Medical Devices
Friday, 05 August 2022 (12:00 - 1:30PM) 6.0 RAC Credits Member: $150 NonMember: $175
Key principles and considerations in designing and executing a real-world evidence study for medical-device evaluation will be outlined.
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.
     
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Books Books
Fundamentals of US Regulatory Affairs, 11th Edition
Member: $147.50 Nonmember: $197.50
This 11th edition presents information covering all lifecycle stages of regulated healthcare products in the US.
On-demand On-demand
Regulatory Intelligence and Its Value in Regulated Industry
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
The fundamentals of global regulatory intelligence, and how it can be used to influence regulatory decision making throughout a development program and lifecycle management of a therapeutic product.
On-demand On-demand
How to Facilitate Regulatory Meetings
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will help prepare regulatory professionals for the difficult task of meeting facilitation.
Books Books
Fundamentals of Canadian Pharmaceutical, Biologic and Medical Devices Regulations
Member: $100.00 Nonmember: $150.00
A compilation of Fundamentals of Canadian Pharmaceutical and Biologics Regulations and Fundamentals of Canadian Medical Device Regulations.
On-demand On-demand
What You Need to Know About FDA Regulation of Medical Product Promotional Labeling
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will discuss considerations for implementing quality systems and procedures that will help you remain in compliance with promotional labeling regulations.
On-demand On-demand
Successfully Integrating Cybersecurity Risk Management into International Regulatory Submissions
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
This webcast will focus on how cybersecurity risk management impacts international regulatory submissions and more.
RAC Prep RAC Prep
RAC (Drugs) Practice Test
Member: $85.00 Nonmember: $105.00
RAC Prep Bundle RAC Prep Bundle
RAC (Devices) Prep Toolbox with Print Edition of Fundamentals of Medical Devices Regulations
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.

All Results

RAC Exam RAC Exam

RAC Devices Examination Autumn 2022

Member: $490.00 Nonmember: $615.00
Testing Window :
31 October 2022 To 9 December 2022
Registration Deadline : 6 October 2022
RAC Exam RAC Exam

RAC Drugs Examination Autumn 2022

Member: $490.00 Nonmember: $615.00
Testing Window :
31 October 2022 To 9 December 2022
Registration Deadline : 6 October 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
Registration Deadline : 16 June 2022
RAC Exam RAC Exam

RAC Devices Examination Summer 2022

Member: $490.00 Nonmember: $615.00
Testing Window : 11 July 2022 To 19 August 2022
Registration Deadline : 16 June 2022
On-demand On-demand

Plan to Accelerate Your Time to Drug Submissions

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
We'll discuss each stage of the submission, variations such as size of the development program, type of submission, and dealing with governance bodies.
On-demand On-demand

Are you prepared for June 24th? FDA Promotional Materials Submissions in eCTD Format

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
Learn the need-to-know information for providing your promotional materials submissions in the eCTD format.
On-demand On-demand

SaMD Product Development: Addressing Challenges through Early Integration of Regulatory, Quality and Clinical Data Strategies

Member: $0.00 Nonmember: $20.00
This webcast will focus on best practices and proven strategies to address challenges presented by today’s shifting SaMD regulatory environment, and discuss the keys to commercial success.
Books Books

Software as a Medical Device

Member: $145.00 Nonmember: $200.00
SaMD will help readers uncover whether their software is subject to global medical device regulations, understand the regulatory implications, and develop their SaMD strategy.
On-demand On-demand

Purity is a Virtue: A Practical Guide to the Reporting of Impurities

1.0RAC Credits
Member: $0.00 Nonmember: $20.00
Increase your understanding of the regulatory guidances (e.g., ICH, FDA, and EMA) available on impurities, including key take-away messages.
Online Course Online Course
Medical Device Certificate Elective Medical Device Certificate Elective

Regulation of IVDs in the US and Major Markets Outside the US [5.0 RAC]

5.0RAC Credits
Member: $545.00 Nonmember: $745.00
This course provides a basic overview of IVDs, including an historical background focused on regulatory requirements. It introduces key regulations and guidelines necessary for effective product development.