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Shifting to more strategic decision-making and shaping the regulatory landscape are definitely challenges RA professionals need to deal with.

What is the potential of AI in pharmaceutical product development?

This is a vast field which will fundamentally change the way we currently work in drug development. High Throughput screening of drug candidates on cell arrays was a start, nowadays, we are more thinking around how to design artificial study arms to leverage real-world evidence in clinical studies. This could – given the fact that the artificial study arms represent the current standard of care (SOC) – reduce the number of patients that are randomised to SOC arms and therefore increase the number of patients that can receive the innovative drug that potentially is superior to SOC. The regulatory environment has to change with these possibilities so that results generated this way can be acceptable to regulators.


Where do you see the biggest importance of regulatory affairs in the pharma industry?

Regulatory affairs is the interface to the regulatory authorities, which is needed to be able to place a drug on the market to generate revenue. However, it is also an internal interface between functions, and needs to bridge clinical development and market access, as nowadays it is not enough to get a drug approved. There is the reimbursement factor in many countries of the world where regulatory and access have to work hand in hand to get the drug approved and generate revenue. It is a whole new way of strategic thinking for regulatory professionals.


What are the challenges of a regulatory affairs professional?/What are the challenges of the regulatory affairs profession?

Nowadays, the challenges for a regulatory professional shift more and more to strategic decision-making and shaping the regulatory landscape. Pure filing, dossier compiling and publishing, submissions and other technical tasks will most likely be more and more shifted towards computers and these jobs will be lost to regulatory affairs professionals in the future. There will be more and more demand for regulatory professionals with excellent scientific, strategic and communication skills, as the regulatory work will shift to tasks that involve negotiations, shaping the field, influencing, storytelling with data – human interactions, plain and simple. Regulatory Affairs is moving away from filing and submitting, but towards strategic partnership and close cross-functional interactions within a company and with external stakeholders such as regulators and payers.

Join Anne at our Pharmaceutical Regulatory Affairs Summit coming up in May where she will deliver a presentation on Regulatory Affairs iStrategy – RA Strategy in Europe in the Information Technology Age

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