Editorial
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EditorialOctober 2022 Editorial: Great expectations for medical technologies
Few would dispute that the medical technology regulatory system continues to creak under the strain imposed by the regulations on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic devices (Regulation (EU) 2017/746). At the time of going to print, the Medical Device Coordination Group (MDCG) issued proposed ...
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Editorial
September 2022 Editorial: Regulatory 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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Editorial
July/August 2022 Editorial - A 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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Editorial
June 2022 Editorial: How 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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Editorial
May 2022 Editorial: CMC 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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Editorial
April 2022 Editorial: The future of pharmaceuticals is green
It has become clear that understanding the environmental impact of human activity is of the utmost importance. The healthcare sector must also play its part. Both by realising its impact on the environment and by building upon opportunities to enhance longterm organisational resilience.
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Editorial
March 2022 Editorial: The 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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Editorial
February 2022 Editorial: Regulatory 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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Editorial
January 2022 Editorial: What 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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Editorial
December 2021 Editorial: A 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!
