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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.

15 results
of 2
3d heart

The industry witnessed a world-first last week, as the US Food and Drug Administration  released guidance for manufacturers 3D printing medical products

This year’s news of the first 3D printed drug...

Contributor: Chanice Henry
Tags:
Tue, 12/12/2017
vaccine

Despite concern expressed by the pharmaceutical industry, Catalyst Corporate Finance argues that the UK’s decision to leave the European Union in fact represents a major opportunity for the country’s dynamic and world-leading pharmaceutical...

Contributor: Catalyst Corporate Finance
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Tue, 12/05/2017
risk thumbnail

Senior pharmaceutical professionals are risking their career prospects because of a widespread lack of awareness on new data privacy legislation

New global research reveals that professionals who fail to facilitate their data being stored...

Contributor: Pharma IQ
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Tue, 11/28/2017
AI in Pharma

Drug development approaches a fascinating era as the trend of digitalization introduces sophisticated technologies which can neutralize costly hazards faced in R&D pipelines, according to a new deep-dive report by Pharma IQ.

Intelligent...

Contributor: Chanice Henry
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Tue, 11/14/2017
stress

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
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Tue, 08/08/2017
inspection

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
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Mon, 08/07/2017
reg

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
Tue, 07/25/2017
hands

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
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Tue, 07/18/2017
Chan

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
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Fri, 07/14/2017
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
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Fri, 07/14/2017
15 results
of 2