The Evolving Role of the Regulatory Affairs Professional By Preeya Beczek - Independent Regulatory Affairs Expert Typical Eras and Environments for the RA Professional Key skills and qualities of a RA professional Key RA skills as an Operational Resource Key RA skills as a Business Leader Key RA skills [...]
Regulatory Information Management (RIM) is one of the highest priority investment areas in Life Sciences R&D today, driven by the need to greatly improve the efficiency of regulatory globally, currently averaging 43% across 18 RIM capabilities[1], and manage regulatory information as a true enterprise asset. In this paper, we will examine why – even now [...]
Regulatory Information Management (RIM) is clearly transitioning to an enterprise capability with growing connections to other critical functional areas while some potential “game changing” technologies emerge. Our 2016 World Class RIM baseline has now moved to an industry standard based on our 2018 research results and input from 31 contributing companies in our design [...]
Our annual white paper is written to provide a clear industry status of Regulatory Information Management (RIM) highlighting the current state, key trends and priorities, investment focus, projected capability and organization change, and a comprehensive update on the provider landscape. This year we have an exciting addition that focuses on defining and measuring World Class [...]
Our annual white paper is written to provide an industry status of Regulatory Information Management (RIM) containing the current state, key trends, investment focus, projected change, vendor landscape and a perspective of what is 2nd generation RIM. This is based upon several recent large biopharmaceutical benchmark studies, client work, and our insight. RIM continues to [...]
Goals • Where is Industry today and what is Next Generation or World Class RIM? • What are industry priorities and investments? • Achieving and Measuring World Class RIM Referenced Benchmark • 2014 Next Generation Regulatory Information Management and Intelligence: Strategy, Investments, and Status (n = 41) • 2015 Next Generation Content Management (n = [...]
Although Content Management has been maturing for the past decade, there is still tremendous work to be done! Goals – Content Management Industry Status, Priorities, Investments – Rate of Expected Change / Enterprise Governance – Increasing Value Several Referenced Surveys – 2015 Next Generation Content Management (n = 21) – 2014 Next Generation Regulatory Information [...]
Collaboration is at the center of many organizational, technological and process initiatives. We believe a fundamental shift in how companies operate has taken hold and our tracking of collaboration trends / methods has supported many companies with their strategic investments and direction. This involves changes to operating policies, information and content structures, technologies, team / [...]
Globalization and organization virtualization are driving the exponential growth of global virtual work environments faster than most organizations can develop the competencies required to effectively manage the increased operational complexity. Having the competency to effectively manage global virtual complexity typically has not been viewed as a strategic lever to increase performance; however this is changing [...]
The number of global virtual work environments is rapidly increasing as businesses and organizations execute global strategies to grow revenues, reduce operational costs or fulfill their mission. Global strategies offer tremendous benefits including easier access to global talent, increased productivity by leveraging time-zone difference, and the opportunity to draw on regional expertise to develop new [...]
