By : Diane Mauriello
Effective medical writing is the key to successful clinical submissions. Medical writing should be effective in terms of cost, time and effort. Other characteristics of effective medical writing for regulatory submission include quality-controlled, quality-assured, consistent, accurate, version correct, data-driven, GCP-driven, process and procedure adherent. In order to maximize the potential for a positive regulatory filing with the FDA or similar regulatory bodies in countries outside the US, medical writing for clinical submission should planned and managed to the characteristics early in the development of a document to be written.
Consider all documents and components, for example, appendices, and narratives, tables listings, figures and graphs required for a regulatory submission, the following experienced based guidance is intended to simplify the process:
* Challenge: The regulatory submission for a drug for example has 5 CTD (Common Technical Document) Modules, "what documents and document components are to be written"? Solution: Develop a TOC (Table of Contents).
* Challenge: The regulatory submission will require a format, "what format will be followed"? CTD? Legacy NDA? 505 (b)(1) or (2)? Solution: Choose a format.
* Challenge: The clinical submission will require source documents to support the written documents, "what are the source documents, which will be included in the clinical submission"? Solution: Develop a TOC that reaches this level of granularity!
* Challenge: The clinical submission will require a team effort between writers, QC (Quality Control), QA (Quality Assurance), sponsor functions, experts, CROs (Contract Research Organizations), etc., "what is the process for file and information transfer between team members onsite and offsite, in-house and remote"? Solution: Develop a process and procedure and adhere to that process and procedure throughout the clinical submission. Communicate the process and procedure to all team members at the beginning to obtain team commitment to follow while informing of the consequences for deviating from.
For effective medical writing for clinical submission, these are important points to consider early in the process.
Once the submission team establishes a TOC with the FDA or relevant regulatory submission body for the clinical filing, responsibilities and accountabilities are assigned to individual medical writers. Common questions that arise include: "Who will write which documents? Will the documents be written by the sponsor? Will the documents be written by the pharmaceutical functional areas? Will the documents be written by the CRO or will the documents be written by consultants, members of a high level medical writing project/clinical submission team asked to participate (outsourced) by the sponsoring pharmaceutical company?"
These and other questions will be addressed in the Dante Resources Effective Medical Writing article series.
Job Vacancy , Indonesia Job , Job Indonesia
Effective medical writing is the key to successful clinical submissions. Medical writing should be effective in terms of cost, time and effort. Other characteristics of effective medical writing for regulatory submission include quality-controlled, quality-assured, consistent, accurate, version correct, data-driven, GCP-driven, process and procedure adherent. In order to maximize the potential for a positive regulatory filing with the FDA or similar regulatory bodies in countries outside the US, medical writing for clinical submission should planned and managed to the characteristics early in the development of a document to be written.
Consider all documents and components, for example, appendices, and narratives, tables listings, figures and graphs required for a regulatory submission, the following experienced based guidance is intended to simplify the process:
* Challenge: The regulatory submission for a drug for example has 5 CTD (Common Technical Document) Modules, "what documents and document components are to be written"? Solution: Develop a TOC (Table of Contents).
* Challenge: The regulatory submission will require a format, "what format will be followed"? CTD? Legacy NDA? 505 (b)(1) or (2)? Solution: Choose a format.
* Challenge: The clinical submission will require source documents to support the written documents, "what are the source documents, which will be included in the clinical submission"? Solution: Develop a TOC that reaches this level of granularity!
* Challenge: The clinical submission will require a team effort between writers, QC (Quality Control), QA (Quality Assurance), sponsor functions, experts, CROs (Contract Research Organizations), etc., "what is the process for file and information transfer between team members onsite and offsite, in-house and remote"? Solution: Develop a process and procedure and adhere to that process and procedure throughout the clinical submission. Communicate the process and procedure to all team members at the beginning to obtain team commitment to follow while informing of the consequences for deviating from.
For effective medical writing for clinical submission, these are important points to consider early in the process.
Once the submission team establishes a TOC with the FDA or relevant regulatory submission body for the clinical filing, responsibilities and accountabilities are assigned to individual medical writers. Common questions that arise include: "Who will write which documents? Will the documents be written by the sponsor? Will the documents be written by the pharmaceutical functional areas? Will the documents be written by the CRO or will the documents be written by consultants, members of a high level medical writing project/clinical submission team asked to participate (outsourced) by the sponsoring pharmaceutical company?"
These and other questions will be addressed in the Dante Resources Effective Medical Writing article series.
Job Vacancy , Indonesia Job , Job Indonesia
No comments:
Post a Comment