Pharma IQ Glossary: Drug Regulatory Affairs
Drug Regulatory Affairs refers to all aspects within the pharmaceutical development process 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.
EU Clinical trial Regulation: Producing plain language summaries
June 15 by Pooja PhogatProducing simplified overviews of clinical studies for the general public isn’t as straightforward a proposition as it might seem.
EMA Policy 0070: 5 ways to balance patient privacy with better data utility
April 16 by Pooja PhogatPooja Phogat, regulation and compliance expert at Kinapse, provides insight on the most effective approaches that reflect the spirit of the Policy
FDA releases new guidance on 3D printed medical products
December 12 by Chanice HenryThe industry witnessed a world-first last week, as the US Food and Drug Administration released guidance for manufacturers 3D printing medical products
‘Brexit a major opportunity for UK pharma’
December 05 by Catalyst Corporate FinanceDespite 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...
GDPR could push pharmaceutical careers into the slow lane around the globe
November 28 by Pharma IQSenior pharmaceutical professionals are risking their career prospects due to a widespread lack of awareness on new data privacy legislation
The Future Of Drug Discovery: AI 2020
November 14 by Pharmaceuticals & Biotechnology EditorDrug development approaches a new era as digitalization introduces sophisticated technologies which can neutralize the costly hazards in pharma’s R&D pipelines, according to our new study
Globalization tangles early access programs into legal maze
August 08 by Chanice HenryExperts have urged that legislation on early access programs needs to be tightened to protect the seriously ill
Surprise pharma inspections uncover 50% failure rate
August 07 by Chanice HenryThe China Food and Drug Administration (CFDA) conducted over 430 pharma inspections last year, which saw over 50% of the drug manufacturers disappoint expectations
Combination products – A 5 point checklist for compliance approval
July 25 by Chanice HenryAfter a decade in development, products in a multi-billion dollar sector are falling at the last hurdle – under-the-gaze of the regulatorCombination products, or drug and device products, fuse a medic...
Combating terminal conditions: The Right to Try movement
July 18 by Elizabeth MixsonSince 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 treat...
Clinical inspection readiness perspectives: CRO vs Sponsor
July 14 by Pharma IQIf 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? Pharma IQ compares the perspe...
Cell therapy wins FDA recommendation
July 14 by Chanice HenryThe 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.
