Pharmaceutical News and Updates

New GVP Guideline on Vaccines

The new Guideline on the Pharmacovigilance of Vaccines against infectious agents has been released for comments from Industry, healthcare professionals, patients’ organisations. The final release is planned for Q4 2013. We have summarised below, for those of you who are less familiar with PV in Vaccines or Biologicals, some sections…

EMA Work Program for 2013

by, Simon Ruini 13 March 2013 The European Medicines Agency (EMA) has just released the work program for 2013. The executive director Guido Rasi stated that the Agency will pursue the following priority areas, in an order of relevance that he has not assigned, but that Pharma Design interprets…

GVP Audit, Module IV

The final version of EMA’s Module IV, regarding Pharmacovigilance Audits, came into effect 13 December 2012. There were several relevant changes to the draft version and we have listed them below: IV.B.2. It is no longer stipulated that the risk assessment for the strategic, tactical and operational planning should…

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 organizational models based on partnerships, alliances and even crowd sourcing are changing talent needs,…

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 over this period by 600%. But success rates from proof of concept to registration have…

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Legislation (GVP modules) in Europe is an attempt to harmonise and rationalise a complex set of regulations, which are out of date and purpose.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 and responsibilities and also ensure a better interaction between the Industry and regulatory assessors. Regulators…