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Competency in Regulatory Writing- Skills to enhance – Pubrica

i.tRegulatory writer can either work with pharmaceutical company or in contract research organization <br>ii.tHighly skilled regulatory writer are required for preparing the complex document<br>iii.tActs as a bridge between the researcher and governing regulatory bodies<br><br>Reference : https://pubrica.com/services/physician-writing-services/<br>Why pubrica?<br><br>When you order our services, we promise you the following u2013 Plagiarism free, always on Time, outstanding customer support, written to Standard, Unlimited Revisions support and High-quality Subject Matter Experts.<br><br>Contact us :t<br>Web: https://pubrica.com/<br>Blog: https://pubrica.com/academy/<br>Email: sales@pubrica.com<br>WhatsApp : 91 9884350006<br>United Kingdom: 44-74248 10299<br>

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Competency in Regulatory Writing- Skills to enhance – Pubrica

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  1. COMPETENCY IN REGULATORY WRITING- SKILLS TOENHANCE An Academic presentationby Dr. Nancy Agens, Head, Technical Operations, Pubrica Group: www.pubrica.com Email:sales@pubrica.com

  2. Today'sDiscussion Outline InBrief Introduction RegulatoryWriters Concepts in Medical Field with Good Writing Skill Conclusion

  3. InBrief Regulatory writer can either work with pharmaceutical company or in contract research organization. Highly skilled regulatory writer are required for preparing the complex document.Actsas a bridge between the researcher and governing regulatorybodies.

  4. Introduction Regulatorywriting is a technical and scientific document which represents pre and post-clinicalresearch. Regulatory writers write the clinical document based on the regulation of nationalauthority. These documents include Clinical Study Protocols, Informed Consent Form, Investigator Brochures (IBs), the Common Technical Document (CTD), and Clinical StudyReports(CSRs). Protocols follow a prescribed format of writing a regulatory document which includes the background, design and outcome along with the statistical determination of theefficiency.

  5. RegulatoryWriters Regulatory writers should coherently articulate the modifications in case of performing the changes in thedocuments. These documents include patient information leaflets and prescribing information, clinical reports, and subjectarticles. The qualification of Regulatory writers will be Doctorate in life science, medical or paramedical professionals, work as the writers at pharmaceutical companies and clinical researchorganization. The submission documents are of two types, Common Technical Document (CTD) modules and Aggregate safetyreports.

  6. Concepts in Medical Field with Good Writing Skill Usually, the regulatory writers work close with doctors, clinical researchers and statisticians. Technically the regulatory writer should be familiar with concepts andterminologies in medical field along with the good writingskill. Statisticswas used in all clinical trials and mostly in writing the researchoutcome. Every medical writers should have basic understandings about confidence intervals, regression analyses, randomization schemes, P values, andt-tests. Write should also have good understanding about research designandpresent precisely to thereaders

  7. Conclusion Regulatorywriterwas considered as the main communicatoramong the research group and the governingbody. Collaboration of researchers, attention to the details and timeliness are the key skills important thewriter. Overall, the writer should have interest in handling data; possess the quality and the achievement will be easily derived.

  8. ContactUs UNITEDKINGDOM +44-1143520021 INDIA +91-9884350006 EMAIL sales@pubrica.com

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