V. "Bala" Balasubramanian, PhD, MBA

The fundamental challenge within any regulatory function in the life sciences sector is the notion that capturing regulatory information in a sufficiently detailed and timely manner is more an (un)necessary evil rather than a corporate asset required for efficient functioning of the business. In this presentation, the author will highlight the need for treating regulatory information as a corporate asset, compare and contrast with other verticals such as banking and financial sectors where… Show more

The fundamental challenge within any regulatory function in the life sciences sector is the notion that capturing regulatory information in a sufficiently detailed and timely manner is more an (un)necessary evil rather than a corporate asset required for efficient functioning of the business. In this presentation, the author will highlight the need for treating regulatory information as a corporate asset, compare and contrast with other verticals such as banking and financial sectors where information is key to their core existence. For instance, how many times have we ever received wrong monthly statements from our banks or brokerage firms? Very rarely. This is because high-quality information is key to the functioning of those industries. Similarly, regulatory within pharmaceuticals must treat quality and timely information as key to the success of their business. We will review challenges managing regulatory information and also review process, people, and technology considerations to better enable the timely collection and management of high-quality regulatory information.
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The European Medicine Agency’s Identification of Medicinal Products (IDMP) requires information integration across multiple functions and systems such as regulatory, labeling, safety, manufacturing, supply chain, clinical and quality. In addition to meeting EMA’s compliance requirements, IDMP is coming at an opportune time when there is greater need for end-to-end information integration across the pharmaceutical value chain in order to improve organizational efficiencies and greater… Show more

The European Medicine Agency’s Identification of Medicinal Products (IDMP) requires information integration across multiple functions and systems such as regulatory, labeling, safety, manufacturing, supply chain, clinical and quality. In addition to meeting EMA’s compliance requirements, IDMP is coming at an opportune time when there is greater need for end-to-end information integration across the pharmaceutical value chain in order to improve organizational efficiencies and greater visibility. This paper describes how an enterprise architecture (EA) approach is best suited to integrate multiple systems together across multiple functions. Show less

This presentation focused on the relevance and relationship of Master Data Management to IDMP.

The presentation focused on the importance of looking at IDMP beyond compliance in order to enable regulatory operational excellence.

The need for end-to-end visibility of regulatory information has been the driver for implementing integrated RIM solutions. IDMP requires even greater integration across multiple functions and systems such as regulatory, labeling, safety, manufacturing, supply chain, clinical and quality. In this presentation, we introduce how an Enterprise Architecture approach is best suited to integrate multiple systems together across multiple functions. We introduce the relevance of an Information… Show more

The need for end-to-end visibility of regulatory information has been the driver for implementing integrated RIM solutions. IDMP requires even greater integration across multiple functions and systems such as regulatory, labeling, safety, manufacturing, supply chain, clinical and quality. In this presentation, we introduce how an Enterprise Architecture approach is best suited to integrate multiple systems together across multiple functions. We introduce the relevance of an Information Services Bus to integrate systems and an IDMP data warehouse to manage integrated data for aggregated reporting. Show less

We provide an extended framework for SharePoint governance by building on Microsoft's Governance Model and adding ITIL-like components in order to run SharePoint as a true enterprise service. We provide an overall approach along with some pragmatic case studies on how to achieve governance based on organizational priorities and constraints.

This article in the DIA Global Forum provides an overview of Social Media, along with a systematic approach on how best to think about the various dimensions of Social Media as they pertain to the Life Sciences.

Article requires DIA Membership

Presentation at AIIM conference about a pragmatic approach to SharePoint governance in an enterprise setting.

It was a forerunning article of its time on the relevance of document management for the web based on "write-once-publish-many" model of managing and disseminating Web content for a product and services marketing application built as part of TGA at Merrill Lynch.

A case study on how we have designed a large-scale hypermedia authoring and publishing system using document management and Web technologies to satisfy our authoring, management, and delivery needs. We describe our systematic design and implementation approach to satisfy requirements such as a distributed authoring environment for non-technical authors, templates, consistent user interface, reduced maintenance, access control, version control, concurrency control, document management, link… Show more

A case study on how we have designed a large-scale hypermedia authoring and publishing system using document management and Web technologies to satisfy our authoring, management, and delivery needs. We describe our systematic design and implementation approach to satisfy requirements such as a distributed authoring environment for non-technical authors, templates, consistent user interface, reduced maintenance, access control, version control, concurrency control, document management, link management, workflow, editorial and legal reviews, assembly of different views for different target audiences, and full-text and attribute-based information retrieval. Show less