Date: 12th & 13th June 2018
time: 9.00am
Venue: Lionel Memorial Auditorium, Sri Lanka Medical Association, No 6, Wijerama Mawatha, Colombo
Programme
Day 1: 12th June 2018
Introduction
President FERCSL
Introduction to GCP, Principles. What is GCP? Need for GCP?
Prof Priyadarshani Galappaththy
Professor in Pharmacology
FM, Colombo
https://drive.google.com/file/d/1Ro67fvNQ_OZzBcT5WtFjB6uKWqIaX6Q3/view?usp=sharing
Role and Responsibilities of PI
Prof Priyadarshani Galappaththy
Professor in Pharmacology
FM, Colombo
https://drive.google.com/file/d/1Itu-H_wOQ0bNaGOBKdbvHe3BpH7TXaE9/view?usp=sharing
Drug development process
Dr Channa Ranasinha
Senior Lecturer in Pharmacology,
FM, Kelaniya
https://drive.google.com/file/d/1VhLDG1w0aHkj6kPX-kMlUJ1St-8pzQvA/view?usp=sharing
Regulatory requirements for clinical trials and legal frame work
Mr Arjuna Pathmaperuma
Regulatory Pharmacist
NMDRA/ SCOCT
https://drive.google.com/file/d/12yGio1fsDAvcsVdWJkPRkqIICUDkOLSI/view?usp=sharing
Clinical Trial protocol and Investigation Brochure
Prof G R Constantine
Professor in Clinical Medicine,
FM, Colombo
https://drive.google.com/file/d/1LdBZxvAA8ufQmPQlsy_dIKU-vmcSVGTy/view?usp=sharing
Participant safety and adverse effects
Prof Shalini Sri Ranganathan
Professor in Pharmacology
FM, Colombo
https://drive.google.com/file/d/1OsIYV_MRp1n9KAeX1-aPaQtf0eNvirYW/view?usp=sharing
Documentation and record keeping
Dr Noel Somasundaram
Consultant Endocrinologist
https://drive.google.com/file/d/1S4Z04qAEDVN7rSrDKNewqoFrvQzsxtwy/view?usp=sharing
Day 2 – 13th June 2018
Ethics review committee – function with special ref to GCP and Clinical Trials
Dr. Panduka Karunanayake
Senior Lecturer in Clinical Medicine, FM, Colombo
Secretary ERC, FM Colombo
https://drive.google.com/file/d/1lnO5RMnjYLNl3ZMKmaXkyDI0gDzLjPns/view?usp=sharing
Informed consent
Dr Manori Gamage
Senior Lecturer, FMS, USJ
https://drive.google.com/file/d/1T_dKUE0rzTkCN8tcp-eJhXhWt0a2WDKA/view?usp=sharing
Research ethics in Clinical Trials
Prof. Chandanie Wanigatunge
Chairperson, FERCSL
Chairperson, ERC SLMA
https://drive.google.com/file/d/11u62rMNTJdK_EebAlGeKYLBc1udeJ4Jf/view?usp=sharing
Investigational products
Prof Shalini Sri Ranganathan
Professor in Pharmacology
FM, Colombo
https://drive.google.com/file/d/1jiHWmZ1f7LDUoK1RfxxsMJGNYpuQbNWg/view?usp=sharing
Role of the sponsor & Contract Research Organization (CRO)
Prof Asitha de Silva
Senior Professor of Pharmacology,
FM, University of Kelaniya
https://drive.google.com/file/d/1v0CY5c_iWKRHhpjRr5V0rlY7c0TEFR7L/view?usp=sharing
Research Misconduct and Conflict of Interest
Dr Malik Fernando
ERC, SLMA
https://drive.google.com/file/d/1c5LhATYyJf30Y3Z9NehjVho_Mbvo3w-X/view?usp=sharing