Benefit-risk assessment model for medicines - Developing a structured approach to decision making 13-14th June 2005, The Georgetown Inn, Washington DC, USA As public accountability grows for decisions taken [...]
A new paradigm for clinical research 3rd-4th October 2005, Mandarin Oriental Hotel, Washington DC, USA Current paradox The pharmaceutical industry’s investment in R&D is rising inexorably but success rates [...]
The Regulatory Agencies in Latin America share a common goal with the research-based pharmaceutical companies that they regulate. This is to ensure that new medicines become available to patients [...]
The regulatory agencies in the Middle East and African region that were included in this study share a common goal with the research-based pharmaceutical companies that they regulate. This [...]
The regulatory agencies in South East Asia and the Western Pacific share a common goal with the research-based pharmaceutical companies that they regulate. This is to ensure that new [...]
Post-approval commitments and conditional authorisations 12-13th May 2005, Woodlands Park Hotel, Surrey, UK Background When a marketing approval is issued for a new medicine there are always certain statutory [...]
Building quality into regulatory dossiers and the review process: Knowing and meeting customer expectations 2nd-3rd December 2004, Woodlands Park Hotel, Surrey, UK Overview This was the fourth Workshop organised [...]
Beyond benchmarking: What are the key metrics that agencies and companies should use to measure performance? 4-5th October 2004, Lansdowne Resort, Virginia, USA Why participate in benchmarking exercises? This [...]
Although it is the goal of most major pharmaceutical companies to achieve global development for new medicines with simultaneous submission of the regulatory dossier in the three main ICH [...]
A summary of the outcome of a survey carried out by the CMR International Institute for Regulatory Science among pharmaceutical companies. Although the pharmaceutical industry is moving towards integrated [...]