Pharmaceutical News and Updates
-
Talent gap, a research from PWC
A talent gap in the scientific workforce has biopharmaceutical companies searching outside for fresh skills and alternate approaches to R&D staffing, according to PwC’s Health Research Institute (HRI) in a new report published today. New…
-
R&D: The Widening Gap between Success and Failure
The Office of Health Economics (OHE) has released a new study examining drug development costs over the past 30 years. The study finds that out-of-pocket costs to bring a new medicine to market have increased…
-
Good Pharmacovigilance Practice (GVP)
The new Pharmacovigilance Legislation (GVP modules) in Europe is an attempt to harmonise and rationalise a complex set of regulations, which are out of date and purpose. The main objective is to define clear roles…
-
From Drug Manufacturers to value-added Providers
Countries have being implementing cost containment measures since at least 2000. What is ‘new’, since the ‘financial crisis’ of 2008, is the pace and the severity with which budget controls are applied. Politicians are influencing…
-
The new Price and Reimbursement for Pharmaceutical Products suggests big changes, but is still in the making
The Pharmaceutical Price Regulation Scheme (PPRS) is the current UK-wide price regulation scheme for branded prescription medicines supplied to the NHS. It applies across the four nations of the UK. The PPRS covers all branded…
-
Real World Data
By Simon Ruini Since 2007, all major stakeholders involved in the development, marketing, authorisation and use of pharmaceutical products have felt the need for a change of their interaction and approach to the current system…
-
From PSUR to PBRER, more focus on Benefit/Risk
The EMA has invited comments on the new ICH-E2C guideline on periodic safety reporting. The periodic safety report on marketed medicinal products maintains the old reporting timeframe, with the IBD (international Birth Date) to be taken…
-
Simplified filing and review of studies in Austria
By Simon Ruini, London The Ethics Committee of the Medical University of Vienna has approved a new submission method of clinical research projects and also their assessment is now available online. Unlike in the past,…
-
European Medicines Agency releases good pharmacovigilance practice modules for public consultation
The European Medicines Agency has released the first batch of modules on good pharmacovigilance practices (GVP) for public consultation until 18 April 2012. Each of the seven modules released today covers one major process in…
-
EU publishes new drafts of patient information and pharmacovigilance proposals
The European Commission has published the revised proposals on pharmacovigilance and information to patients, following its decision on 2 December last year to separate the two. The two proposals, which each take the form of…