Date: 22nd of January 2016
Time: 2.00 pm
Venue: Council room of the SLMA
The agenda of the AGM is as follows:
Date: November 22 – 24, 2015
Venue:
NAGASAKI UNIVERSITY Sakamoto Campus
1-12-4, Sakamoto, Nagasaki City, Nagasaki
November 22, 2015
November 23-24, 2015
November 24, 2015
Date : 8th and 9th October 2015
Time : 8.30 am to – 4.00 pm
Venue : Lionel Memorial Auditorium, Sri Lanka Medical Association, No 6, Wijerama Mawatha, Colombo 7
Introduction
Dr Malik Fernando FERCSL MC
Prof Jennifer Perera President SLMA
Research ethics in Clinical Trials
Dr Chandanie Wanigatunge Senior Lecturer in Pharmacology, FMS, USJ Secretary, ERC SLMA
https://drive.google.com/file/d/1Tzoafmqik67puMS3v8e0wwboBK0soQrg/view?usp=sharing
Drug development process
Prof Asita de Silva Professor in Pharmacology, FM, Kelaniya Director, Clinical Trials Unit, Kelaniya
Regulatory requirements for clinical trials and legal frame work
Mr Arjuna Pathmaperuma Regulatory Pharmacist NMDRA/ SCOCT
https://drive.google.com/file/d/1tzHPXMP9Yt8gg9yWO5gvwGKLsewp1SpN/view?usp=sharing
Introduction to GCP, Principles and Need
Prof Priyadarshani Galappaththy Professor in Pharmacology FM, Colombo
https://drive.google.com/file/d/1DRQ0_v7HO5E5WK_gmo0ZDG02H9kefftL/view?usp=sharing
Dr Panduka Karunanayake Senior Lecturer in Clinical Medicine, FM, Colombo Secretary ERC, FM Colombo
https://drive.google.com/file/d/1iXkyiti2oS1rV1v6yRTiUGy2chCXKlIz/view?usp=sharing
Role and Responsibilities of PI
Dr Lalith Wijayaratne Consultant heumatologist
https://drive.google.com/file/d/1lsc8jK_v4_xvX1kErCIq_azatFNM2nNI/view?usp=sharing
Role of the sponsor & CRO
Prof Vajira Dissanayake Professor in Anatomy, FM, University of Colombo Board member, FERCAP
https://drive.google.com/file/d/11fu_Z-Y95IL3LdRWOt-e1td6IwWrV-8b/view?usp=sharing
Clinical Trial protocol and IB
Dr Nirmala Wijekoon Senior Lecturer in Pharmacology, FM Kelaniya
https://drive.google.com/file/d/10hSziZ8_K4sMIu5DWCgcg4tKB1G9JT4R/view?usp=sharing
Documentation & record keeping
Dr G R Constantine Senior Lecturer in Clinical Medicine, FM, Colombo
https://drive.google.com/file/d/1LhiRHtYELNLb83sXjlbzuYzS8t0sIewR/view?usp=sharing
Participant safety and adverse effects
Prof Rohini Fernandopulle Senior Professor in Pharmacology, KDU
https://drive.google.com/file/d/192krj50TIt2uFaStJp9Hlnj-9U0iICBw/view?usp=sharing
Investigational products
Prof Shalini Sri Ranganathan Professor in Pharmacology FM, Colombo
https://drive.google.com/file/d/1rSfTUHzqCGO5ji-6_EpyH-LPufnKiBc3/view?usp=sharing
Research misconduct and COI
Dr Malik Fernando ERC, SLMA
https://drive.google.com/file/d/1Xnmx8jurZccNXSJH8V6qphNkGjtH1GfL/view?usp=sharing
Informed
Dr Rasika Perera Senior Lecturer in Biochemistry, FMS, USJ
https://drive.google.com/file/d/13_uujp63aXJbLEsE7ngz4hGS1taCoAaq/view?usp=sharing
Ethical issues in clinical trials – ERCs experiences. Panel discussion
10 minutes each from the 4 SIDCER recognised ERCs
Medical Research – History & Scandals
Prof. Hemantha Senanayake MBBS, MS, FRCOG, FSLCOG – Professor in Obstetrics and Gynaecology, University of Colombo; Chairperson, Ethics Review Committee, Faculty of Medicine, University of Colombo
https://drive.google.com/file/d/1w8uGMNZ8YOGmxP_-9FL3wmknoZB4_64h/view?usp=drive_link
History of Research Ethics Review in Sri Lanka
Dr. Vajira H. W. Dissanayake MBBS, PhD (Nottingham) – Senior Lecturer in Anatomy/Genetics, University of Colombo; Joint Secretary, Ethics Review Committee, Faculty of Medicine, University of Colombo
https://drive.google.com/file/d/1-7kVuy4vY2YUdIFjg1zN3pbxTYWHzCfa/view?usp=sharing
Research ethics regulations and guidelines – International and Sri Lankan
Dr. Malik Fernando MBChB (Bristol)– Member, National Bioethics Committee, National Science Foundation, Sri Lanka; Chairperson, Ethics Committee, Sri Lanka Medical Association; Member, Ethics Review Committee, Sri Lanka Medical Association; Member, Ethics Review Committee, Faculty of Medicine, University of Colombo
https://drive.google.com/file/d/1p_kpG9DKksgietVhbyihvB0vVmVDwbmr/view?usp=sharing
Purpose and function of Ethics Review Committees
Prof. Reidar Lie MD, PhD – Professor of Philosophy, University of Bergen, Norway; Senior Investigator in Charge of the Unit of Multilateral Research, National Institutes of Health, Maryland, USA; adjunct professor of research ethics at Thammasat University, Bangkok, Thailand
https://drive.google.com/file/d/1eCy1uK6Ic6X667-gk-CQ33FKL0aLtQ56/view?usp=sharing
Collaborative partnership
Dr. Enoka Corea MBBS, MD – Senior Lecturer in Microbiology, University of Colombo; Joint Secretary, Ethics Review Committee, Faculty of Medicine, University of Colombo
https://drive.google.com/file/d/1NeTxz5P1VX9lr3cRIkZtDJt2eFikf7rL/view?usp=sharing
Social Value
Dr. Malik Fernando MBChB (Bristol)– Member, National Bioethics Committee, National Science Foundation, Sri Lanka; Chairperson, Ethics Committee, Sri Lanka Medical Association; Member, Ethics Review Committee, Sri Lanka Medical Association; Member, Ethics Review Committee, Faculty of Medicine, University of Colombo
https://drive.google.com/file/d/1XbfQg_ciPegCmneJcz6xSnYzhZ1sI3Ag/view?usp=sharing
Scientific validity
Prof. Hemantha Senanayake MBBS, MS, FRCOG, FSLCOG – Professor in Obstetrics and Gynaecology, University of Colombo; Chairperson, Ethics Review Committee, Faculty of Medicine, University of Colombo
https://drive.google.com/file/d/1duTdNJanu-UusQoLYtNZP0BnVwHH7nwe/view?usp=sharing
Fair participant selection
Dr. Enoka Corea MBBS, MD – Senior Lecturer in Microbiology, University of Colombo; Joint Secretary, Ethics Review Committee, Faculty of Medicine, University of Colombo
https://drive.google.com/file/d/1q9kRzCADEmdgAGhR4PWUATgnqzvZXgYo/view?usp=sharing
Favourable risk benefit ratio
Dr. Vajira H. W. Dissanayake MBBS, PhD (Nottingham) – Senior Lecturer in Anatomy/Genetics, University of Colombo; Joint Secretary, Ethics Review Committee, Faculty of Medicine, University of Colombo
https://drive.google.com/file/d/1oa3ZIoUZbbsbJeVSokWGPojq035KrvoL/view?usp=sharing
Conflicts of interest
Prof. Rohini Fernandopulle MBBS, PhD (Colombo) – Professor in Pharmacology, Faculty of Medicine, University of Colombo; Member, Ethics Review Committee, Faculty of Medicine, University of Colombo
https://drive.google.com/file/d/1W93ua2wMn_3gtwg8W64wt2M4ixLbCJp_/view?usp=sharing
Informed consent
Prof. Hemantha Senanayake MBBS, MS, FRCOG, FSLCOG – Professor in Obstetrics and Gynaecology, University of Colombo; Chairperson, Ethics Review Committee, Faculty of Medicine, University of Colombo
https://drive.google.com/file/d/156DtWaeo5uGOTV5r3K7IkmsXeLJEyxzZ/view?usp=sharing
Respect for human participants
Dr. Enoka Corea MBBS, MD – Senior Lecturer in Microbiology, University of Colombo; Joint Secretary, Ethics Review Committee, Faculty of Medicine, University of Colombo
https://drive.google.com/file/d/1olPCK0RvhLwBnJXaBsmSXUi8YbWVYCzb/view?usp=sharing
International Collaborative Research
Prof. Reidar Lie MD, PhD – Professor of Philosophy, University of Bergen, Norway; Senior Investigator in Charge of the Unit of Multilateral Research, National Institutes of Health, Maryland, USA; adjunct professor of research ethics at Thammasat University, Bangkok, Thailand
https://drive.google.com/file/d/1z-J-yGwFYhNpK2ERSBQitLCs7s2VPnHN/view?usp=sharing
Clinical trials
Dr. Priyadarshani Galapatthy MBBS, MD, FRCP – Senior Lecturer in Pharmacology, University of Colombo; Member, Ethics Review Committee, Faculty of Medicine, University of Colombo
https://drive.google.com/file/d/1SCSCy6nOvMJ8spOMoDcbZ-Ni9fXSln4V/view?usp=sharing
Post research benefits
Prof. Mandika Wijerathne MBBS, DM, FRCS – Professor in Surgery, University of Colombo; Member, Ethics Review Committee, Faculty of Medicine, University of Colombo
https://drive.google.com/file/d/1RL_KY5_uhW-hjO-HSvrqLy530cu3UnIq/view?usp=sharing
Research on Stored Tissue and Genetic Research
Dr. Vajira H. W. Dissanayake MBBS, PhD (Nottingham) – Senior Lecturer in Anatomy/Genetics, University of Colombo; Joint Secretary, Ethics Review Committee, Faculty of Medicine, University of Colombo
https://drive.google.com/file/d/17rgZAM-YSvBNSQGxzMp_C69ID7WAWazD/view?usp=sharing
Epidemiological research
Dr. Sriyakanthi Beneragama MBBS. MD(Community Medicine), MIRB – Epidemiologist, National STD/AIDS Control Programme, Ministry of Health, Sri Lanka; Member, Ethics Review Committee, Faculty of Medicine, University of Colombo
https://drive.google.com/file/d/1jpCs61kxIkJgH7N74n1wfdGkAVNzq57Z/view?usp=sharing
Implementation of uniform guidelines for ethics review in Sri Lanka
Dr. Malik Fernando MBChB (Bristol)– Member, National Bioethics Committee, National Science Foundation, Sri Lanka; Chairperson, Ethics Committee, Sri Lanka Medical Association; Member, Ethics Review Committee, Sri Lanka Medical Association; Member, Ethics Review Committee, Faculty of Medicine, University of Colombo
https://drive.google.com/file/d/1TVO7ly2ycgxNkCRsQCdrbNRsZ3HbT3Lm/view?usp=sharing
