COMPETENCYIN REGULATORY WRITING- SKILLS TO ENHANCE

An Academic presentation byDr. Nancy Agens, Head, Technical Operations, Pubrica Group: www.pubrica.comEmail: sales@pubrica.com

In Brief

Introduction

Regulatory Writers

Concepts in Medical Field with Good Writing Skill

Conclusion

Outline

Today's Discussion

In Brief

Regulatory writer can either work with pharmaceutical company or in contract research organization. Highly skilled regulatory writer are required for preparing the

complex document. Acts as a bridge between the researcher and governing regulatory bodies.

Regulatory writing is a technical and scientific document which represents pre and post-clinical research.

Regulatory writers write the clinical document based on the regulation of national authority.

These documents include Clinical Study Protocols, Informed Consent Form, Investigator Brochures (IBs), the Common Technical Document (CTD), and Clinical Study Reports (CSRs).

Protocols follow a prescribed format of writing a regulatory document which includes the background, design and outcome along with the statistical determination of the efficiency.

Introduction

Regulatory Writers

Regulatory writers should coherently articulate the modifications in case of performing the changes in the documents.

These documents include patient information leaflets and prescribing information, clinical reports, and subject articles.

The qualification of Regulatory writers will be Doctorate in life science, medical or paramedical professionals, work as the writers at pharmaceutical companies and clinical research organization.

The submission documents are of two types, Common Technical Document (CTD) modules and Aggregate safety reports.

Usually, the regulatory writers work close with doctors, clinical researchers and statisticians.

Technically the regulatory writer should be familiar with concepts and terminologiesin medical field along with the good writing skill.

Statistics was used in all clinical trials and mostly in writing the research outcome.

Every medical writers should have basic understandings about confidence intervals, regression analyses, randomization schemes, P values, and t-tests.

Write should also have good understanding about research design and presentprecisely to the readers

Concepts in Medical Field with Good Writing Skill

Conclusion

Regulatory writer was considered as the main communicator among the research group and the governing body.

Collaboration of researchers, attention to the details and timeliness are the key skills important the writer.

Overall, the writer should have interest in handling data; possess the quality and the achievement will be easily derived.

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