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Siniša Belina

Siniša Belina

Sinisa started his professional career at Pliva (now member of the TEVA Group), where in addition to his responsibilities in manufacturing, he also engaged in successful EDMS implementation project. Belina later joined KRKA’s Regulatory Affairs Department, and finally moved to AMPLEXOR. He applies his detailed knowledge of pharmaceutical documentation and processes to areas of business process analysis and optimization of EDMS.

 

Recent Posts


Regulatory transformation: cloud reality check

Written by Siniša Belina in Life Sciences on 19/10/16


An industry debate at AMPLEXOR’s annual user conference in June examined the role of cloud services in driving the next generation of regulatory information management in life sciences, and I want to share with you the main points of the discussion.

The need for regulatory information management (RIM) transformation is driving new interest in cloud services, particularly access to the latest applications via Software as a Service (SaaS) delivery models. But there are different approaches to the cloud, and data sensitivities to consider, so it is rarely a straightforward decision.

It was in this context that AMPLEXOR recently hosted a major industry panel debate, keen to sort the fact from the fiction and establish some best-practice approaches to cloud-based service use in life sciences. The discussion, chaired by Steve Scribner of consultancy The Scribner Group, brought together heavyweight regulatory experts and consultants from across the sector: Romuald Braun of uanotau; Peter Brandstetter of IBM’s GBS Life Sciences team; Torben Thorhauge of NNIT; and Steve Gens of Gens Associates. The audience, made up of AMPLEXOR customers, also participated in the debate.

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Regulatory transformation: the time is now

Written by Siniša Belina in Life Sciences on 21/06/16


Regulatory compliance has always been a double-edged sword for life sciences. It is an essential and central focus for investment because public safety, consumer confidence and sales depend on it. Yet this preoccupation with rules and risk can also be a barrier to innovation, because any deviation from the status quo increases the chance of non-compliance.

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