Orbis clinical drug safety trial#
Orbis clinical drug safety professional#

As well, regulatory agencies are collaborating more and developing work-sharing, reliance and collaborative reviews to facilitate the review of these innovative products coming through the regulatory system ( 7, 8).

Manufacturing is utilizing digital twins to test out new systems it is becoming more integrated, with internet-of-things, robotics and continuous manufacturing processes becoming more routine ( 6).

Orbis clinical drug safety trial#

The clinical trial enterprise is integrating more modeling, newer statistical methodology, and artificial intelligence to improve efficiencies in this stage of development ( 4, 5). The increasing integration of real-world evidence will enable medicines to reach the market at an earlier stage of development due to faster clinical trials and lead regulators to place greater emphasis on post-market regulation. The rise in patient input into all aspects of drug development, including regulatory review, has also impacted medicinal product regulation ( 3). At the same time, advances in science have fueled a large increase in the number of cell and gene therapies coming to market and are delivering more benefits for patients ( 1, 2).

Orbis clinical drug safety professional#

We discuss some of the challenges and provide insights for the regulatory professional to remain at the forefront of these trends and prepare for their impacts on their work.ĭigital disruption is affecting all aspects of drug development, including the way medicinal products are regulated.

This article will discuss the various trends that are impacting the development of new therapies for alleviating disease and how these trends therefore impact on the role of the regulatory affairs professional. Rapid changes due to advances in science, digital disruption, a renewed focus on the centrality of the patient in all stages of therapeutic product development and greater collaboration between national regulatory authorities have been accelerated by the COVID-19 pandemic. Changes in global megatrends, such as geopolitical shifts and the rise of the green economy, have emphasized the importance of manufacturing and supply chain security, and reducing the environmental impacts of product development. This field is facing a myriad of forces impacting all aspects of the development, regulation and value proposition of new therapeutic products.

The field of regulatory affairs deals with the regulatory requirements for marketing authorization of therapeutic products.

2Sanofi, Macquarie Park, NSW, Australia.

1Faculty of Medicine and Health, Sydney Pharmacy School, The University of Sydney, Sydney, NSW, Australia.