Bala heads VB Insights, an advisory firm for the Healthcare and Life Sciences sector. Bala brings over 35 years of experience. During his long tenure, he has been responsible for the introduction of Web, document management, global team collaboration, and regulatory information management applications to large pharma. Until recently, Bala was Head of the Healthcare and Life Sciences Industry Solutions Group at Orion Innovation. As an entrepreneur and a thought leader, he has been involved in initiatives to transform regulatory affairs from a document-centric function to a data-driven function. Bala has been associated with DIA for more than 14 years, most recently as the DIA RIM Working Group subteam lead for the RIM Reference Model.

Keith founded and has led the IT & Life Science Strategy for Court Square since it's inception in 1995. Keith understands the intersection between IT and Quality within the Life Science industry and continues to drive FDA Compliant IT Solutions. Instrumental in creating the Audit Ready Compliant Cloud (ARCC) platform specifically used for qualified and validated applications from pre-clinical to manufacturing with a specialty in Clinical and Regulatory systems. Keith is also co-founder of both RegDocs365, a regulatory content management repository and EmpiraMed, an ePRO, EDC and Registry software solutions company.

Pat Shafer is a Managing Director at FTI Consulting. He is responsible for delivering services, solutions and thought leadership for pharmaceutical, biotech and medical device clients. He has over 30 years of experience solving complex global challenges and helping clients achieve their strategic and operational objectives in the areas of regulatory affairs and operations, quality, compliance, clinical operations, safety and surveillance, manufacturing, supply chain, medical affairs and commercial compliance. He currently leads the development of the RIM Whitepaper 3.0 as part of the RIM Working Group, and leads the Culture of Quality initiative as part of the FDA/MDIC Case for Quality.

Cary is the Managing Partner of LeapAhead Solutions and has over 30 years of experience in life sciences focused on leading strategic initiatives to drive increased business productivity, enhance regulatory compliance, and simplify information management and the use of technology. Her areas of expertise include regulatory information management, intelligent automation, data strategy/governance, e-submissions, R&D and GxP content management, IT strategy, enterprise architecture, Agile, business process optimization, and project/program/portfolio management. Cary co-leads the DIA RIM Working Group, leads the DIA RIM Intelligent Automation Topic Team, and regularly serves as an industry thought leader.