Are life sciences companies frightened of “the cloud”?

4^th International Conference on Pharmaceutical Regulatory Affairs

September 08-10, 2014 DoubleTree by Hilton Hotel Raleigh-Brownstone-University, USA

David Hawley

Keynote: Pharmaceut Reg Affairs

Abstract :

While industry in general and society as a whole increases its use of Cloud Services, and gains the benefit of the flexibility, rapid response and lowered cost that characterizes these systems, there is one area of industry that stands fearfully on the sidelines - Life Sciences. For a sector that touts its cutting-edge technology and blue-sky vision, the situation is different when it comes to the use of new technologies from other industries, Pharmaceutical, Medical device and similar companies are barely using cloud systems for any services that fall under the scope of the Code of Federal Regulations (or similar rules world-wide). Those that are using such systems mostly confine it to a few well-established vendors of Sales systems, and the like. Is the Life Sciences Industry right to be wary? Do the regulatory authorities deprecate cloud systems and how do you actually define a cloud-based system in any case? This talk will outline the situation as it exists now, critically examine some common myths, and suggest some ways forward.

Biography :

David Hawley is Director of Life Sciences at Business & Decision North America. Twenty years later he left the company which by that time was part of the Pfizer group, having worked in Engineering, shop-floor Production Management of Pharmaceuticals and Medical Devices, and various roles in information technology. On joining the Business & Decision group in 2004, he has worked on more than forty projects in the UK, Europe, North America, Asia and elsewhere, specialising in the compliance of infrastructure and large configurable systems such as ERP systems. He has worked on SAP, Oracle EBS, Microsoft AX, Epicor, Plex and others.