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
Programme
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