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Drug Regulatory Affairs

Drug Regulatory Affairs refers to all aspects within the pharmaceutical development process of medicinal products and how they are subject to various degrees of regulation. The pharmaceutical law frame, guidelines covering Quality, Safety and Efficacy as well as Health Authorities' attitudes and requirements etc. have a great influence on the drug development process and the success of it. Regulatory affairs professionals deal with these aspects.


Experts have urged that legislation on early access programs needs to be tightened to protect the seriously ill

Through expanded early access programs (EAPs), terminally- ill patients that fit certain criteria will be...

Contributor: Chanice Henry
08/08/2017 06:51:17 AM EDT

The China Food and Drug Administration (CFDA) conducted over 430 pharma inspections last year, which saw over 50% of the drug manufacturers disappoint expectations 

Around 39 unannounced inspections took...

Contributor: Chanice Henry
08/07/2017 08:57:17 AM EDT

After a decade in development, products in a multi-billion dollar sector are falling at the last hurdle – under-the-gaze of the regulator

Combination products, or drug and device products, fuse a medical element (biologic...

Contributor: Chanice Henry
08/01/2017 12:18:33 PM EDT

Do terminally ill patients have a “right to try”? With that question in mind, we created this Right To Try At-A-Glance to provide an overview of which U.S. states have already implemented Right To Try laws and recent developments...

Contributor: Elizabeth Mixson
07/18/2017 05:28:11 AM EDT
Trial Master File Europe 2017

If your company was handed with a notice for a clinical trial inspection right now, what would the reaction be?  A feeling of calm confidence or a rush of slight concern? In this ebook Pharma IQ compared the perspectives of a Clinical Research...

Contributor: Pharma IQ
07/14/2017 07:05:19 AM EDT

The US FDA’s recommended approval of Novartis’ CAR-T cell therapy pushes the product closer to being the first treatment of its kind available on the market.

Bruno Strigini, CEO, Novartis Oncology said: "...

Contributor: Chanice Henry
07/14/2017 05:35:50 AM EDT
MT 5

QP, QC and laboratory managers are liable for lost data. Unknown to many lab professionals, a standalone system with electronic records is problematic. These systems can risk a laboratory being issued an FDA warning letter and incurring extremely...

06/19/2017 11:43:47 AM EDT

The General Data Protection Regulation (“GDPR”) applies from 25 May 2018, and introduces a new set of rules relating to the collection, storage and processing of personal data. Pharmaceutical organisations should prepare for the...

Contributor: Martin Bonney
05/02/2017 05:42:21 AM EDT
Jack Wong

As Asia emerges as the largest player in the pharmaceutical market, pharma regulations are fast gaining attention among pharma companies in Asian countries to protect the health and safety of consumers. The ever-changing and increasing scrutiny...

Contributor: Jack Wong
12/19/2011 07:00:00 PM EST
Helen Winsor

Pharmaceutical companies are placing even more importance on the pharma regulatory aspects of data and information management and how efficiently information is translated to drug market applications. Neil Gow, Head of Records Management for UCB...

Contributor: Helen Winsor
09/13/2010 08:00:00 PM EDT
Career Spotlight: Pharma Regulatory Affairs

Pharma regulatory affairs professionals play an essential role in ensuring all pharmaceutical products comply with regulations governing the industry. Those working in pharma regulatory affairs jobs not only work in the initial application phase...

Contributor: Pharma IQ
08/31/2010 08:00:00 PM EDT