Devender Kumar Kashyap

Background

About Devender Kumar Kashyap

500+(BA/BE & Clinical Trial) eCTD m5 & combined-m5 dossier preparation as per current applicable regulatory guidelines (USFDA, CANADA, EMEA, CDISCO, WHO, COSTA RICA, Chille, South Africa, Philliphines & ROW). • Regulatory queries, response preparation and submission resolution within internal & external department/sponsor/client and stakeholders. • CSR along with appendices, tabular listing, regulatory table (FDA-table, EU-Table, CSBE-table, FOREBI & Summary table) • Compliance Implementation: To ensure dossier submission as per applicable current regulatory guidelines • Additional Support to Clinical Pharmacology Unit: dose administration, pharmacy, clinical activities & ensure error free data compilation. • SAS & Phoenix Data: Review/resolve error in preliminary & Final Pharmacokinetic report along with appendices. • CDISC DATA SET: preparation as per current regulatory specification (USFDA) & Review/resolve/ compilation in final package of eCTD module with specific guidelines. • Successfully faced various regulatory inspection at clinical site. USFDA (Dec 2013, Jul 2014, Oct 2016, Dec 2017, Aug 2020) CDSCO (Dec 2014, Sep 2015, Aug 2017, Sep 2017, Sep 2020), NPRA (Malaysian) inspection (Sep 2017, Jul 2019) INFARMED (EU)(Apr 2018) • Performing root cause analysis and taking corrective and preventive actions (CAPA) in consultation with Head CPU & MSA for quality issues/deviations. • Imparting training and development activities to new joiners/cross functional trainees. • Preparing and updating SOPs (CPU/MSA/GEN/GEO) as per the current technicalities and regulatory requirements and responsible for identifying gaps in the identified function and proposing requirements to the management. • Medical Writing Deliverables (Protocol, ICD, CRF, CSR, REMS, eCTD (Module 5) & CDISC • Liaising with the Project Manager, Sponsor and internal contributors • Compliance: Ensuring to availability all documents prior study conduction (Ethics approval, T-License, IPs, communication to all vendors, trained personnel, readiness of ICU/Ambulance/Emergency Lift etc.) • Team Management • ISI Pharma Tool (Validation Software for eCTD module) • Adobe Acrobat DC Professional • Adobe Auto Bookmark (Plug-in Software for eCTD module) • EDMS (Electronic Document Management System) • CWLMS (Compliance Wire Learning Management System) • Rave EDC (Electronic Data Capture) • MSB (My Signature Book) • FIS (Forms Issuance System) • SUFLAM (Subject's Data) • CSV (Computer System Validation)