All Editorial articles
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EditorialEqual access to medicines:
finding the balanceRegulatory Rapporteur July/August 2023 | Volume 20 | No.7 This edition of TOPRA’s Regulatory Rapporteur journal explores some of the challenges faced by regulatory professionals around the world; from the African regulatory ecosystems, to health technology assessment (HTA), and the ongoing ...
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EditorialClinical trials:
Ethical, ecological
and economic changeIn the pursuit of global – or even regional – standards in requirements to support medical product development; is industry keeping up? Can regulations and guidelines keep up with the pace of change?
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EditorialThe need for robust quality management
It is a simple fact that the establishment of a robust quality management system (QMS) can both drive – as well as facilitate – regulatory compliance across all layers of business and operations in the pharma and MedTech industries. However, there is no doubt that the mention of QMS can ...
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EditorialRegulatory operations: Evolution and revolution
‘Operations’ does not quite do justice to the critical role that these individuals play in the global team
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EditorialA new era of digital and data-driven innovations
Such significant advances in information management and technology are providing us with sophisticated tools and new ways of working
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EditorialHow regulators are navigating the evolving pharmacovigilance landscape
In the area of regulatory affairs and pharmacovigilance (PV), we are constantly confronted with new laws, guidelines and other regulations
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EditorialCMC acceleration is driven by a scientific revolution
The role of CMC technical and regulatory experts is essential for ensuring continuous innovation and successful regulatory approvals
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EditorialThe future of pharmaceuticals is green
The healthcare sector is not immune from societal concerns about the environment and will have to go green over the next few years
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EditorialThe UK and Brexit – innovation and optimism in uncertain times
Although there is still alignment with the EU, the regulatory strategy for new submissions and variations has changed and we must adapt to such changes. No doubt further changes are on the way, which we must be ready for again.
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EditorialRegulatory support for drug development – maximising options for timely patient access
As medicinal innovation evolves and becomes more complex, there is a need for agencies to support this innovation by establishing additional expedited pathway routes to improve drug development and its evaluation
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EditorialWhat does 2022 have in store for clinical trials?
Although the pandemic is not over yet, as we move forward, we must embrace these advances and not return to ‘business as usual’ despite the challenges such ways of working entail
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EditorialA regulatory revolution – driven by data
On occasions it felt like time was standing still in 2021, with further restrictions and lockdowns taking us out of our ‘normal’ routines and nothing much seeming to happen day-to-day, yet it still feels like the year has come around quickly to the Annual Symposium issue!