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 ...
TrackersTrackers
COVID-19 therapeutics tracker
Posted 01 July 2022 By Jeff Craven
Updated 01 July with new information on Paxlovid, Evusheld, molnupiravir, Regkirona and ivermectin.
Regulatory NewsRegulatory News
PFDD: Draft guidance seeks to demystify clinical outcomes assessments
Posted 30 June 2022 By Ferdous Al-Faruque
The US Food and Drug Administration (FDA) this week issued a sweeping draft guidance intended to help stakeholders incorporate patient experience data through the use of meaningful clinical outcome assessments (COAs).
RoundupsRoundups
Euro Roundup: MHRA plans wave of medtech regulation after consultation shows support for reform
Posted 30 June 2022 By Nick Paul Taylor
MHRA proposed a slate of medtech reforms considering the Cumberlege Review and the opportunity presented by Brexit. The proposals were intended to improve patient safety, increase transparency, more closely align the UK with internationa...
Regulatory NewsRegulatory News
FDA proposes rule broadening nonprescription drug access for consumers
Posted 28 June 2022 By Jeff Craven
The US Food and Drug Administration (FDA) has issued a new proposed rule that would allow drug companies to add conditions for consumers to access nonprescription drug products.
RoundupsRoundups
Asia-Pacific Roundup: TGA adds chapters on SaMD, personalized devices to clinical evidence guidelines
Posted 28 June 2022 By Nick Paul Taylor
Australia’s Therapeutic Goods Administration (TGA) has updated its clinical evidence guidelines for medical devices, adding new chapters on software as a medical device (SaMD) and personalized medical devices (PMDs), prompted by regulato...
RF Quarterly, June 22: Regulatory history
Welcome to the June issue of RF Quarterly in which global regulatory experts write about Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), medical device regulations in China’s National Medical Products Administration (NMPA), an...
The history of clinical trial disclosure
Posted 27 June 2022 By Thomas Wicks, MBA
The scope and complexity of requirements for global clinical trial disclosures and data sharing have increased substantially over the last 20 years. Most leading countries have specific regulations pertaining to trial conduct, and many h...
Virtual Programs Virtual Programs
Preparing to Take the RAC Drugs Exam
Tuesday, 04 October 2022 (11:00 - 4:00PM) 12.0 RAC Credits Members: $970 NonMembers: $1,150
Designed specifically for those preparing to take the RAC Drugs exam. This workshop will be facilitated by a panel of RAC-certified regulatory professionals and focuses on sharpening strategic test-taking skills.
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.
Virtual Programs Virtual Programs
China Drug Regulatory Update
Tuesday, 16 August 2022 (11:00 - 12:30PM) 1.0 RAC Credits Member: $150 | NonMember: $175
This virtual program will provide regulatory professionals with helpful information, strategies, and insights about drug registration with China NMPA.
RAC Prep Bundle RAC Prep Bundle
RAC (Drugs) Flashcards
Member: $40.00 Nonmember: $50.00
Study drug terminology at your fingertips in an easy-to-use flashcard format.
On-demand On-demand
Audits and Inspections: How to Drive a Standardization Strategy that Sticks (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $25
Audits and inspections: how to drive a standardization strategy that sticks
On-demand On-demand
Sponsored Webcast: Smarter Clinical Document Automation Now for your T&D Requirements Later (On-Demand)
1.0 RAC Credits
Member: $0 NonMember: $25
This webcast will illustrate how automation through the use of advanced technology allows for the production of clinical documents with future disclosure in mind.
Online Course Online Course
Single Certificate Single Certificate
Regulatory Affairs Certificate Upgrade: Pharmaceuticals
Member: $1230.00 Nonmember: $1540
If you have already successfully completed a Regulatory Affairs Certificate in Medical Devices, you can complete the two remaining core courses of the Dual Certificate and three addition electives.
On-demand On-demand
Meet the Authors, Regulatory Intelligence 101, Third Edition
Member: $0.00 Nonmember: $0.00
The three leading authors will answer your questions on why this book needed to be revised and why all regulatory intelligence (RI) professional can benefit from this update.
Books Books
Risk Management Principles for Devices and Pharmaceuticals
Member: $130.00 Nonmember: $180.00
Expanded and updated risk management information on healthcare products around the world.
On-demand On-demand
How to Effectively Talk to Regulators
1.5 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn the dos and don’ts of communicating with a regulator, including examples of industry effectively working with FDA.
On-demand On-demand
A Risk-Based Approach to Validation for Life Sciences Companies
1.0 RAC Credits
Member: $0.00 Nonmember: $20.00
Learn how a risk-based validation approach can meet compliance requirements and maintain quality while streamlining the validation process.