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.