GCP Workshop on Clinical Trials 2015

posted Apr 21, 2016, 8:56 AM by FERCSL Editor   [ updated Oct 2, 2016, 7:14 PM by Prasad Ranatunga ]

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

Workshop Concluded Successfully
Resource files attached at the bottom of this page


Photo Gallery


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

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

Introduction to GCP, Principles and Need
Prof Priyadarshani Galappaththy
Professor in Pharmacology
FM, Colombo

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

Role and Responsibilities of PI
Dr Lalith Wijayaratne
Consultant Rheumatologist 

Role of the sponsor & CRO
Prof Vajira Dissanayake
Professor in Anatomy, FM, University of Colombo
Board member, FERCAP

Clinical Trial protocol and IB
Dr Nirmala Wijekoon
Senior Lecturer in Pharmacology, FM Kelaniya

Documentation & record keeping
Dr G R Constantine
Senior Lecturer in Clinical Medicine, FM, Colombo

Participant safety and adverse effects 
Prof Rohini Fernandopulle
Senior Professor in Pharmacology, KDU

Investigational products
Prof Shalini Sri Ranganathan.Professor in Pharmacology
FM, Colombo

Research misconduct and COI
Dr Malik Fernando.ERC, SLMA

Informed consent
Dr Rasika Perera
Senior Lecturer in Biochemistry, FMS, USJ

Ethical issues in clinical trials – ERCs experiences .Panel discussion
10 minutes each from the 4 SIDCER recognised ERCs



Presentations

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Apr 21, 2016, 8:57 AM
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