Information Technology
Electronic FDA Submissions
Is APAC prepared for the 2017 mandate?
Two pieces of US legislation impact the future of the life sciences industry the Food and Drug Administration Safety and Innovation Act FDASIA and the Affordable Care Act also known as Obamacare FDASIA establishes user fee acts brings generic drugs under a stronger set of guidelines and sets into motion a countdown to May when all submissions to t...
Emerging Trends in Functional Service Outsourcing
Functional service has been ranked high among the buzz words of the clinical research industry Both sponsor organisations and service providers are equally excited about the opportunities this model offers and the potentially winwin situation it provides to them Sponsor organisations typically send individual protocolrelated service RFPs request fo...
Quality by Design
A rapid and systemic approach for pharmaceutical analysis
Quality by design QbD is defined in ICH Q R guidelines as a systematic approach to pharmaceutical development starting with predefined objectives with an emphasis on product and process understanding control Within the pharmaceutical industry there is increasing discussion about the principles of QbD analytical methods For many years analysts used...
Microsoft
Digital Pharma Initiative
Today life sciences companies around the world find themselves at difficult crossroads While research and development RD spending continues to grow drugs that actually make it to market are mired in a decadelong decline The reasons are numerous and complex Driven by more stringent government mandates aimed at protecting consumer safety and informat...
Regulatory Information Management
Leveraging standards and efficiencies of eCTDs
Within a Regulatory department there are Information Management needs particularly related to the electronic Common Technical Document eCTD submission process There are a number of methods for adding efficiencies to the submission process particularly through automation and standards To begin with what does it mean to add efficiencies From Th...
Right prescription for the Growth of Pharmaceutical Companies
Right prescription for the Growth of Pharmaceutical Companies
The pharmaceutical market in Asia has undergone a paradigm shift in the past few years The major global pharmaceutical companies have shifted their focus to this region to drive their revenue growth Moreover the domestic companies in Asia are also actively participating in the global drug development process At present the pharmaceutical market in...
IT in Pharma
Countering the Information Security Risk
Routine security procedures and regulations fall desperately short of securing a pharmaceutical companys IT systems putting trade secrets as well as employee and customer information at risk of devastating losses Electronic thieves and hackers have evolved from juveniles taking a joyride through corporate networks into organised criminals in rem...
Knowledge Tools
Increasing role in drug development
Both academia and the health industry generate immense amounts of scientific data during their research efforts As a result the academic and industry researchers often find themselves in a position of having more data than they can effectively manage and interpret In addition to data generated directly by researchers huge amount of data is accessib...
Operational Excellence
IT governance, Enterprise Architecture and service management
IT governance is currently a key topic for many IT functions Its definition varies very often but key themes remain essential for all companies effectiveness efficiency and reliability Business value and risk mitigation are also at the centre of this domain It represents a significant part of enterprise governance and due to the horizontal nature o...
Innovative IT
Enabling pharmaceutical Research & Development
Informationrelated challenges are pervasive throughout modern drug discovery They are becoming ever more draconian as the industry leverages powerful new experimental capabilities to create novel therapeutics for unmet medical needs In parallel breathtaking advances in Information Technology IT make possible effective responses to these challenges...
