By Justina Orleans-Lindsay

Pharmacovigilance clinical Writing covers the education of pharmacovigilance files for all phases of the drug improvement procedure (i.e. from scientific improvement via to purposes for advertising authorisations to the post-marketing stage). for every rfile, the ebook offers a assessment of the regulatory framework that governs the content material of the record, by way of functional tips (e.g. scheduling, resource facts, department/functions all for rfile preparation/review, applicable timelines and making plans activities), finishing with a well-known version rfile compliant with the present directions, which might be converted to satisfy particular corporation and product standards.

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Additional resources for Pharmacovigilance Medical Writing: A Good Practice Guide

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21 Global appendices Appendix 1: Cumulative Tabulation of Important Regulatory Request Appendix 2: Investigator’s Brochure (if applicable) Appendix 3: Clinical Studies Completed or Ongoing during the Review Period Appendix 4: Subject Exposure in the Clinical Development Program Appendix 5: Line Listing of SARs Reported during the Review Period Appendix 6: Cumulative Summary Tabulation of SAEs since the DIBD Appendix 7: Abstracts from Scientific Congresses/Symposia (if applicable) A sample line listing and summary tabulation can be found in Appendices 1 and 2, respectively.

6 Post-marketing Data . . . . . . . . . . . . . . . . . . . . 7 References . . . . . . . . . . . . . . . . . . . . . . . 8 Appendices . . . . . . . . . . . . . . . . . . . . . . . List of abbreviations Insert standard abbreviations and definitions table as follows. Abbreviation Definition ADR Adverse drug reaction AE Adverse event CCSI Company Core Safety Information CTD Common Technical Documentation EU European Union MedDRA Medical Dictionary for Regulatory Activities PSUR Periodic Safety Update Report PD Pharmacodynamic PK Pharmacokinetic PT Preferred term SCE Summary of Clinical Efficacy SCS Summary of Clinical Safety SmPC Summary of Product Characteristics TEAE Treatment-emergent adverse event USPI United States Package Insert Note: The table needs to be expanded and completed as required.

2 Extrinsic Factors. . . . . . . . . . . . . . . . . . . 3 Drug Interactions. . . . . . . . . . . . . . . . . . . 4 Use in Pregnancy and Lactation . . . . . . . . . . . . . 5 Overdose . . . . . . . . . . . . . . . . . . . . . 6 Drug Abuse . . . . . . . . . . . . . . . . . . . . . 7 Withdrawal and Rebound. . . . . . . . . . . . . . . . 8 Effects on Ability to Drive or Operate Machinery or Impairment of Mental Ability .

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