Apollo Research & Innovations (ARI) APGDCR- 1 Year Course Advanced Post Graduate Diploma in Clinical Research

Drug Research Introduction Types of drug innovation : New molecules (First in class)- New targets through disease pathways analysis Creates better medicines, explore new indications and make companie market leader Costly affair, very time consuming and success rate is less E.g. Drugs for Orphan diseases, Repatha/Praluent (alirocumab) Proprotein convertase subtilisin/kexin type 9 (PCSK9) - >USD1 bn revenue NCE’s extensions for existing/known target- Simvastatin (Atorvastatin) New Formulations- Paclitaxel (Taxol)=>Abraxane (nab-paclitaxel) Copy/Generics- Atorvastatin (Lipitor)

Large Scale manufacturing Drug & Clinical Research Drug development stages and activities by stage Large Scale manufacturing Phase IV Drug Discovery FDA Review Pre - Clinical Clinical Trials Phase I 20-100 Volunteers Phase III 1000-5000 Volunteers IND submitted NDA submitted 1 FDA approved Drug 10000 compounds 250 Compounds 5 Compounds Phase II 100-500 Volunteers 5 Years 1.5 Years 6 Years 2 Years 2 Years

Course Module Class room Internship Placement Assistance First six months class room training and next 6 months internship Class room Internship Placement Assistance Corporate level training Interactive sessions Power point presentation Real time Live trial exposure Interactions with experts Infrastructure Highly skilled personnel On site exposure to clients Apollo brand Interview Q&A sessions Campus placements Commencement Date: 17th September 2018 Qualifications- B.Pharmacy, M.Pharmacy (all branches), Pharm D B.Sc (Life sciences), M. Sc Biochemistry, Microbiology and Biotechnology MBBS, BDS, B.P.T, M.P.T, BMMS, BAMS B.Sc, M.Sc Nursing, B.Tech, M.Tech (Biotech), MS (Pharmaceutical sciences), Pharma M.B.A

Course Contents Introduction to clinical research and drug development Module 1 Ethical guidelines and regulation in clinical research Module 2 Research methodology and statistics Module 3 Clinical trial process Module 4 Quality management and clinical trial documents Module 5 Clinical trial finance and budgeting Module 6 Clinical data management Module 7 Pharmacovigilance Module 8 Personality Development Module 9

Practical Exposure GCP work shop CRA feasibility Site selection visit Budgeting Clinical trial agreement review Site initiation visit IP receipt and drug accountability ICF process documentation Source documentation Randomization procedures Paper CRF and eCRF entries, discrepancy resolution Lab samples handling and processing including PK samples SAE at site reporting to sponsor and EC SAE narrative writing AE/SAE capturing in source notes CIOMS reporting to EC Site close out visit Archival EC meetings

Courses & Contacts Courses Hyderabad - ADVANCED POST GRADUATE DIPLOMA IN CLINICAL RESEARCH ( APGDCR) POST GRADUATE DIPLOMA IN CLINICAL RESEARCH ( PGDCR) ADVANCED PROFESSIONAL COURSE IN CLINICAL RESEARCH ( APCCR) EXECUTIVE PROGRAM IN PHARMACOVIGILANCE Hyderabad - Ms. Chandana Pal | +91- 9490464322 | +91 9553988504 E-mail : crcourse.hyderabad@apolloari.com New Delhi - Ms. Sunita Kumari | +91- 9560054650 | +91 11 26825612 E-mail : crcourse.delhi@apolloari.com Ahmedabad - Mr. Alex Peter | +91- 7698815042 | +91 7698815045 E-mail : crcourse.ahmedabad@apolloari.com Chennai - Mr. Sathyanarayana | +91- 9841744635 E-mail : crcourse.chennai@apolloari.com

Career Our Top Recruiters Drug Safety Associate Clinical Trial Assistant Clinical Research Associate Clinical Research Coordinator Safety Data Analyst Global PV Scientist Regulatory Affairs Assistant Drug Safety Specialist

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