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Efficient Distribution of Information Across Documents to Support Product's Benefit-Risk Ratio for Patients Worldwide

Track:
Regulatory Affairs and Submissions

Day & Time:
June 17, 10:30AM - 12:00PM (Pacific Standard Time)

Session Number:
240

Room Number:
16B

Level:
Advanced

Type:
Workshop

Title:
Efficient Distribution of Information Across Documents to Support Product's Benefit-Risk Ratio for Patients Worldwide

Chair(s):
Hans van Bruggen, MSc
Director and Senior Regulatory Affairs Consultant
eCTDconsultancy and Qdossier, Netherlands

Description:
Can you work with MS-Word? Likely you will say “Yes.” But how many text processor features beyond that of type writing machine do you use? Likely, lots of post-finalization publishing of the resulting PDF files is needed to get your document eCTD ready. Concerning the content, do you know how to convey your message using supportive and circumstantial information, using many references or even repetition of information out of courtesy for the reader, confirming your statements? These documents contain the requested content but in the context of the objective of that particular time.

Regulatory documentation includes information to support the particular purpose at the time of writing and beyond! Documents have to support products now, and in the future, at the FDA, EMA and other agencies; for INDs and NDAs; where possible for Product A and Product B; drug substance A and drug substance B, etc. Documents can be written once and reused more often. This requires that documents are written as lean stand-alone documents. Specific details that can be deduced from the inclusion of the document in a specific dossier must neither become part of the content, the header nor the naming. Attendees will learn how the 80-20 rule can make them more efficient in using MS-Word beyond the features of a typewriter. Moreover, they will be sensitized for redundant contextual words that block the reusability of documents for other purposes.

Attendees are encouraged to bring their fully charged laptop for interactivity

**Due to workshop format, seating will be limited and will be available on a first come, first served basis.

The San Diego Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive at workshops early in order to ensure seating. Please note, as a workshop with interactivity, this offering will not be recorded.


Learning Objective(s):
Describe the purpose of documents (beyond what is in the guidelines); Define the document granularity, primarily focusing on CTD Module 1, 2; Explain how to omit redundant repetition of information, written cross references, and hyperlinks.