GCP Workshop on Clinical Trials 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


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


Ethics review committee – function with special ref to GCP and Clinical Trials

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 consent

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