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ACADEMIC REGULATIONS FOR B.PHARM PROGRAMME (Semester System with Grade) 2015 3. Phases and Types of Clinical Trials. 4. Documents in Clinical Trial: Investigator Brochure, Protocol (3hrs) Case Report Form, Informed Consent Form; Essential & Amendment in Protocol, (8hrs) Documents in Clinical Trial. 5. Regulatory Affairs in Clinical Research a. Good Clinical Practice: ICH guidelines (E6). (16hrs) b. Good Clinical Practice for clinical research in India (CDSCO guidelines). C. Schedule Y requirements for undertaking clinical trials. 6 Content of Clinical Trial Report as per ICH. (3hrs) 7. Clinical Trial Management: Investigator's meeting, project management, patient monitoring, drug resource and suppliees. recruitment & retention, trial TEXT BoOKS (4hrs) 1. T. K. Pal, S. Agarwal. Clinical Research Practice and Prospects. 2009. CBS Publishers and Distributors, New Delhi. 2. S. Malhotra, N. Shafiq, P. Pandhi. A Comprehensive Clinical Research Manual. 2008. Jaypee Brothers Medical Publishers (P) Ltd. 3. R.B. Ghooi, S. C. Itkar. Essentials of Clinical Research, Nirali Prakashan. Sahoo, F Kemani. Clinical Trial Monitoring: A Professional Hand Book. 2009. The ICFAI University Press. 5. S. K. Gupta. Basic Principles of Clinical Research and Method ology. DEPARTMENT ODF PHARMACY PRACTICE BPH RTA SCTO OF 751 Dr. SABITHA. M PHARA Principal ELECTIVE Amrita School of Pharrfiacy Amrita Vishwa Vidyapeetam APEETH PHARMACOVIGILANCE Health Science opc-42 AIMS Ponekkara P.O. -682 THEORY 3 credits/weekchi,kerala 041, IndeA OS COURSE OUTCOME cO 1. Understand the importance of drug safety monitoring and pharmacovigilance CO 2. Define, classify and assess ADR different methods the CO 3. Describe pharmacovigilance CO 4. Understand the concepts of signal detection, risk assessment and management cO 5. Describe the WHO ADR teminology CO 6. Describe the various pharmacovigilance programmes of WHO and India THEORY 40HRS (3Hrs/ Week) 1. Introduction to pharmacovigilance (2hrs) of in India and globally a. Evolution pharmacovigilance of safety monitoring and pharmacovigilance b. Importance drug C. Stake holders in Pharmacovigilance events (10hrs) 2. Introduction to Adverse drug reactions (ADRs) & Adverse drug ADRs a. Definition and classification of ACADEMIc REGULATIONS FOR B.PHARM PROGRAMME System with Grade) 2015 (Semester b. Mechanism of ADRs C. Severity assessment of ADRS d. Causality assessment of ADRS 3. Pharmacovigilance methods a. Spontaneous ADR monitoring system (10hrs) b. Prescription event monitoring C. Vaccine safety surveillance d. Periodic safety update report (PSUR) e. Phamacovigilance during clinical research f Product quality problem reporting 4. Signal detection, Risk assessment and Management (6hrs) a. Identification of new ADRs b. Prevention of MARIA ADRs and risk management Dr. SABITHA. M C. Methods of collection of ADRs Principal d. Role of pharmacist in pharmacovigilance Amrita School of Pharmacy Amrita Vishwa Vidyapeethem e. Basic in a Amrita Heaith steps setting Pharmacovigilance centre Science CamAPS a-2 AIMS Ponekkara P.O. 5. WHO ADR kerala THAN and Kochi, terminology-Drug disease classification -682 041, IndlaH a. Anatomical, Therapeutic and Chemical classification and codes of drugs b. ICD-10 classification of diseases C. Daily defined doses 6. National and international scenario, various global reporting agencies/ systems (6 hrs) a. Phamacovigilance programme of India b. ADR Reporting Forms & How to fill them ADR monitoring centres d. in Phamacovigilance global perspective e. WHO International drug monitoring programme TEXT BoOKS 1. of G.Parthasarathy, Karin Nyfort Hansen, Milap.C. Nahara. A Textbook Clinical Phamacy Practice-Essential Concepts and Skills. 2nd edition, 2012. Orient Longman, Chennai. 2. K.G. Revikumar, B.D. Miglani. A Textbook of Pharmacy Practice. 1st edition, 2009. Career Publications, Nashik. Roger Walker, Clive Edwards. Clinical Pharmacy and Therapeutics. 4th edition, 2007. Churchill Livingstone, Edinburgh. 4. A.J.Winfield, R.M.E. Richa rds. Pharmaceutical Practice. 3rd edition, 2004. Churchill Livingstone, Edinburgh. REFERENCE BOOKS: 1. M.D Rawlins, J.W Thompson. Textbook of adverse drug reactions. 1st edition, 1977.Oxford University press, Oxford. 2. WHO. International Drug Monitoring. The role of hospital. 1966. Geneva. 3. Adverse Drug Reactions. 2nd edition, Anne Lee (Editor), Pharmaceutical Press, 2006 4. Naranjo C.A, Brusto U, Sellar E.M. et al. A method for estimating the probability of adverse drug reactions. Clin.Pharmacol. Ther. 1981. 30: 239-45.
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