Clini World -Pharmacovigilance

Clini World- is your free, all-in-one study app for Pharmacovigilance, Clinical Research, and Regulatory Affairs. Whether you are an M.Pharm student, pharmacy graduate, fresher, or working professional, master drug safety, clinical trials, and drug approval pathways with structured notes, flashcards, and quizzes — anytime, anywhere. WHO IS THIS APP FOR? • M.Pharm & pharmacy students preparing for exams and interviews • Aspiring Drug Safety Officers, PV Associates, CRA, CRC, and Regulatory Affairs professionals • Clinical research coordinators, monitors, and quality teams • Anyone learning GCP, GVP, ICH guidelines, MedDRA, ICSR, PSUR, CDSCO, FDA, and EMA regulations 3 CORE SUBJECTS — 36 UNITS OF EXPERT CONTENT 1. Pharmacovigilance (PV) Learn adverse drug reaction (ADR) reporting, Individual Case Safety Reports (ICSR), signal detection, risk management, aggregate safety reporting (PSUR/PBRER/DSUR), EudraVigilance, Pharmacovigilance System Master File (PSMF), vaccine pharmacovigilance, MedDRA coding, and Good Pharmacovigilance Practices (GVP). 2. Clinical Research (CR) Master clinical trial phases (Phase I–IV), trial design, protocol development, ethics & human subject protection, Good Clinical Practice (GCP/ICH E6), site monitoring, Clinical Research Associate (CRA) roles, data management, safety monitoring, SAE reporting, and regulatory submissions (IND/NDA). 3. Regulatory Affairs (RA) Understand drug regulation, ICH harmonisation, CTD/eCTD dossier preparation, innovator vs generic pathways, Indian drug regulations (CDSCO), New Drugs & Clinical Trials Rules 2019, GMP/GLP/GDP, post-approval variations, regulatory inspections, and biologics regulations. POWERFUL STUDY FEATURES • Structured syllabus notes — unit-wise chapters aligned to industry topics • Flashcards — revise PV abbreviations, definitions, and key concepts fast • Unit quizzes — MCQs with explanations to test your knowledge • Progress tracking — mark units complete and track your study journey • Study streaks — build a daily revision habit • Bookmarks — save important chapters for quick revision • Course groups — connect with fellow learners in PV, CR & RA • Search — find topics across the syllabus instantly • 100% FREE to download and study WHY CHOOSE CLINI WORLD? Unlike scattered PDFs and expensive courses, Clini World organises pharmacovigilance, clinical research, and regulatory affairs into one clean, mobile-friendly learning experience. Read a chapter, flip through flashcards, and test yourself with quizzes — the complete revision cycle in your pocket. Perfect for exam prep, campus placements, CRA/CRC interviews, PV officer roles, and upskilling in the pharmaceutical and life sciences industry. TOPICS COVERED INCLUDE: Pharmacovigilance | Drug Safety | Adverse Event Reporting | Clinical Trials | GCP | GVP | ICH Guidelines | MedDRA | ICSR | PSUR | Signal Management | Risk Management | CRA | CRC | CRO | Ethics Committee | IRB | CDSCO | CTD | eCTD | GMP | Regulatory Submissions | Post-Marketing Surveillance | Phase IV Studies Download Clini World - Pharmacovigilance today and start your journey in drug safety, clinical research, and regulatory affairs — for FREE! Questions or feedback? Contact us through the app or Play Store listing.