spacer
home >
PUBLICATIONS

 
 
 

spacer

 

Industry Events

DIA Europe 2021

15-19 March 2021, VIRTUAL CONFERENCE

DIA Europe is the must-attend event for all life science professionals working in drug development, from discovery to marketed use. It encourages open collaboration by bringing together representatives from the entire spectrum of the life science landscape and facilitating crucial discussions across several topic tracks: Clinical Development, Regulatory Strategy, Pharmacovigilance, Value and Access, Health Policy, and many more.
More info >>

 
News and Press Releases

SHIONOGI’S NOVEL ANTIBIOTIC, FETCROJA® (CEFIDEROCOL), HAS BEEN SELECTED BY UK’S NICE / NHSE&I AS PART OF AN ANTIMICROBIAL SUBSCRIPTION STYLE REIMBURSEMENT MODEL

The National Institute for Clinical and Health Excellence (NICE) and the National Health Service England and Improvement (NHSE&I) have recognised the potential of Shionogi’s innovative antibiotic, cefiderocol, and selected it for inclusion in this pilot reimbursement model which ‘de-links’ payment from volume of use Shionogi recognises the UK’s leadership role in introducing this first fully ‘delinked’ pilot reimbursement model, which is an important step in making the market for novel antibiotics more predictable and sustainable; we strongly believe in the introduction of further suitable pull incentives in order to help stimulate the antimicrobial development pipeline Fetcroja® (cefiderocol) is indicated for the treatment of infections due to aerobic Gram-negative bacteria in adults with limited treatment options1 Antimicrobial resistance (AMR) is a major health burden which results in over 700,000 deaths globally2 and 5,000 deaths per year in the UK3 from an infection with multidrug-resistant bacteria and this is predicted to kill 10 million people every year globally by 2050, unless action is taken2
More info >>

 
White Papers

Key to Outsourcing Method Development and Validation: A Pragmatic Approach

RSSL

In an industry that is seeing an increasing level of work being outsourced, the Contract Research Organisation (CRO) of choice needs to have proven experience in both the pragmatism and flexibility of the method developer’s mind set and a regulatory background in validation. As companies are focussing on achieving ever shorter times of drug to market, it is vital that a tailored, pragmatic approach is adopted when engaging in both method development and validation activities for an Active Pharmaceutical Ingredient (API) or drug product (DP). Although methods still require a high degree of robustness, the overall strategy should encompass a full evaluation of the regulatory requirements applicable to the particular phase of the drug life-cycle; this is pivotal in Key to Outsourcing Method Development and Validation A Pragmatic Approach order to ensure a successful regulatory submission, where the applicant must demonstrate suitable validation of all methods used to support the filing.
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement