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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.
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.
Fake Weight Loss Drugs: Growing Threat to Consumer Health
October 25th 2024In this episode of the Pharmaceutical Executive podcast, UpScriptHealth's Peter Ax, Founder and CEO, and George Jones, Chief Operations Officer, discuss the issue of counterfeit weight loss drugs, the potential health risks associated with them, increasing access to legitimate weight loss medications and more.
