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Today’s Medical Information (MI) and Medical Affairs professionals are juggling multiple challenges: they must adapt to decentralization, outsourcing and globalization…

Safety departments at Marketing Authorization Holders & Regulatory Authorities are under pressure from all sides. They must constantly stay on…

Rising Expectations from Regulatory Affairs Executives As we all know from experience, not all cloud solutions are the same and…

Artificial intelligence (AI), machine learning, deep learning, natural language processing – in short, cognitive computing, is changing the pharmacovigilance world as we know it. While there’s a lot of talk about how AI will affect jobs, where it will have the most powerful impact is on the quality of work and the speed at which manual tasks can be accomplished.

This is the last in the ArisGlobal three-part blog series on Regulatory Affairs transformation. Digitization is sweeping the life sciences industry, disrupting traditional working practices and opening doors to better ways of collaborating, tracking and sharing documents and data, and gaining clear oversight into the product supply chain.

The life sciences industry is confronting a wave of transformational change, brought about by multiple factors, including the growth of new clinical trial markets, a rapid rise in drug development innovation, reimbursement challenges, heightened regulatory requirements and a demand for evidence-based medicine, among many others. These drivers and the resultant changes are having a profound effect on regulatory affairs.

Regulatory affairs departments are accustomed – and even open — to change and adapting their technology and processes in response…

If you’re in Regulatory Affairs, you know the IDMP-compliance-truck is headed your way. Which questions though are plaguing your team?…

Every one of us at some point will take a medication and likely suffer some sort of adverse reaction. However,…

What are the Challenges in the Pharma Industry Regarding Data Privacy? Data privacy and data retention seem to become more…