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 MCProf Jennifer Perera President SLMA
Research ethics in Clinical Trials
Dr Chandanie WanigatungeSenior Lecturer in Pharmacology, FMS, USJSecretary, ERC SLMA
Drug development process
Prof Asita de SilvaProfessor in Pharmacology, FM, KelaniyaDirector, Clinical Trials Unit, Kelaniya
Regulatory requirements for clinical trials and legal frame work
Mr Arjuna PathmaperumaRegulatory PharmacistNMDRA/ SCOCT
Introduction to GCP, Principles and Need
Prof Priyadarshani GalappaththyProfessor in PharmacologyFM, Colombo
Dr Panduka KarunanayakeSenior Lecturer in Clinical Medicine, FM, ColomboSecretary ERC, FM Colombo
Role and Responsibilities of PI
Dr Lalith WijayaratneConsultant Rheumatologist
Role of the sponsor & CRO
Prof Vajira DissanayakeProfessor in Anatomy, FM, University of ColomboBoard member, FERCAP
Clinical Trial protocol and IB
Dr Nirmala WijekoonSenior Lecturer in Pharmacology, FM Kelaniya
Documentation & record keeping
Dr G R ConstantineSenior Lecturer in Clinical Medicine, FM, Colombo
Participant safety and adverse effects
Prof Rohini FernandopulleSenior Professor in Pharmacology, KDU
Investigational products
Prof Shalini Sri Ranganathan.Professor in PharmacologyFM, Colombo
Research misconduct and COI
Dr Malik Fernando.ERC, SLMA
Informed
Dr Rasika PereraSenior Lecturer in Biochemistry, FMS, USJ
Ethical issues in clinical trials – ERCs experiences. Panel discussion
10 minutes each from the 4 SIDCER recognised ERCs