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Regulatory/Legal

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.

416 results
of 38
Contributor: Sumit Dutta
Posted: 26/09/2017
Sumit Dutta
Arkivum launches Arkivum TRUST enabling the Pharmaceutical, Life Sciences and Health markets to meet core MHRA, FDA GxP and GDPR data integrity guidelines and regulations in a cost-efficient way Full Content »
Contributor: Dane Hartung
Posted: 29/08/2017
Dane TN
Dane Hartung, Director Marketing and Access, Fougera Pharmaceuticals shares best practices for determining if and when you should implement a new Commercial Patient Access Program. Dane also discusses how you should go about ensuring your patient access program is ethical, compliant and effectively differentiates your product. Full Content »
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 »
416 results
of 38