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The Year of Living Openly: Europe and Transparency 2015
The past year has brought significant changes not only in regulatory mandates and guidances but also regarding a broader overall emphasis on coordination of information and processes.
The past year has brought significant changes not only in regulatory mandates and guidances but also regarding a broader overall emphasis on coordination of information and processes.
The regulators have prioritized transparency and harmonization for some time but underscored them to an even greater degree in 2014; 2015 is likely to see the trend intensify.
Improvement in the oversight of companies’ pharmacovigilance systems will also be a priority in the year ahead. Regulators have again taken steps aimed at improving patient safety - and, indeed, at encouraging patients to become more-active participants in their own health. And companies will have to determine how to respond to some of those developments.
Perhaps one of the paramount themes of the year - one that will only grow in the year ahead - is the narrowing gap between pharmacovigilance and regulatory.
All of those trends require pharmaceutical companies to improve their business processes and the ways they manage regulatory information across the enterprise.
To read the article by Dakshayini Kulkarni, click on the latest Pharm Exec Global Digest here.
What Every Pharma CEO Should Know About Unlocking the Potential of Scientific Data
December 11th 2024When integrated into pharmaceutical enterprises, scientific data has the potential to drive organizational growth and innovation. Mikael Hagstroem, CEO at leading laboratory informatics provider LabVantage Solutions, discusses how technology partners add significant value to pharmaceutical R&D, in addition to manufacturing quality.
Key Findings of the NIAGARA and HIMALAYA Trials
November 8th 2024In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses the findings of the NIAGARA trial in bladder cancer and the significance of the five-year overall survival data from the HIMALAYA trial, particularly the long-term efficacy of the STRIDE regimen for unresectable liver cancer.
