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Ensure compliance with external submission standards. Pharma IQ is proud to provide an international, non-biased, central resource, for professionals working in pharmaceutical regulatory affairs to exchange ideas on best practice and share case studies on innovation within the area.

414 results
of 38
Contributor: Chanice Henry
Posted: 15/08/2017
Chan
In response to the recent bioboom, physicians may consider switching patients to a biosimilar for a more affordable alternative. However, this is a decision that shouldn’t be made in haste and has a few crucial points to be considered. Full Content »
Contributor: Chanice Henry
Posted: 08/08/2017
Chan
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 allowed access to unauthorized drugs outside of a clinical trial. These programs aim to give dying patients ethical and controlled strategic access to potentially life- saving medicines before they gain approval. Full Content »
Contributor: Chanice Henry
Posted: 07/08/2017
Chan
The China Food and Drug Administration (CFDA) conducted over 430 pharma inspections last year, which saw over 50% of the manufacturers disappoint expectations Full Content »
Contributor: Chanice Henry
Posted: 01/08/2017
Chan
After a decade in development, products in a multi-billion dollar sector are falling at the last hurdle – under-the-gaze of the regulator Full Content »
Contributor: Elizabeth Mixson
Posted: 18/07/2017
Elizabeth
Since early 2014, more than 30 states in the US have introduced so-called "Right to Try" bills in the hopes of allowing terminally ill patients to access experimental and potentially life-saving treatments. Download the PDF to glance at the Right To Try movement in the US. Full Content »
Contributor: Chanice Henry
Posted: 14/07/2017
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. Full Content »
Contributor: Martin Bonney
Posted: 02/05/2017
Mark
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 Regulation in order to remain compliant. Full Content »
Contributor: Chanice Henry
Posted: 27/03/2017
Chan
Over 60% of you said quality of services was the most important criteria when selecting a CRO. Find out who the TOP 10 CROs are in the industry as voted by our members. Full Content »
Contributor: Pharma IQ
Posted: 20/12/2016
Pharma IQ
The last quarter of 2016 was certainly not short of activity with a £84 million pharma fine issued in regards to drug pricings, an investigation into a suspected supply chain breach and numerous therapeutic approvals. Full Content »
Contributor: Daniel Green
Posted: 15/12/2016
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As China continues to transition from the center of global manufacturing to a more innovation based economy, Israel’s technology sector has attracted increasing Chinese attention. While this is generally the case, it is particularly applicable to Chinese interest in Israel’s life sciences and medtech industry which has experienced rapid growth and development in recent years. Indeed, this industry is playing a pivotal role in the world healthcare market, underpinned by its innovation and excellence in academic research, government support and increasing funding options. These factors are leading to ever more success and record investments, especially from China. Full Content »
Contributor: Pharma IQ
Posted: 19/07/2016
Pharma IQ
As the serialisation industry prepares for various approaching deadlines all over the globe, Pharma IQ has created a printable map to assist with your worldwide track and trace compliance strategies. Full Content »
414 results
of 38