Creating, Managing and Delivering Regulated Content in Pharma

Companies who are highly regulated by government agencies face unique challenges when delivering information to their key stakeholders. When sharing information that must be clinically valid and approved by internal regulatory constituents, pharmaceutical companies are looking for new and better ways to streamline the process not only of the creation and approval of this content, but its dissemination via multiple (validated) channels.

Nichols talks about some of the unique obstacles, adoption hurdles, and systems integrations that must be considered when introducing structured content and DITA into this environment.

What can the audience expect to learn?

Attendees gain a better understanding of the added needs, considerations, and challenges when introducing structured content into organizations that must comply with external regulatory requirements.

Meet the presenter

Jim Nichols

Jim Nichols is the VP of Life Sciences at DitaExchange and also serves as the CEO & President of the Institute for Regulatory Information Submission Standards (IRISS). He has decades of technology experience substantially in the healthcare and life sciences areas.



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