Date : 3rd & 4th November 2016
Start Time : 8.30 am
Venue : Lionel Memorial Auditorium, Sri Lanka Medical Association, No 6, Wijerama Mawatha, Colombo 7
Programme
Day 1: 3rd November 2016
Introduction
Dr Malik Fernando
FERCSL MC
Ethical Aspects in Clinical Trials
Prof. Chandanie Wanigatunge
Professor of Pharmacology, FMS USJ
Secretary, ERC SLMA
https://drive.google.com/file/d/1DA8CdgcwOOG93BZVhZUj7M0MMG2NPIHE/view?usp=sharing
Drug development process
Dr Channa Ranasinha
Senior Lecturer in Pharmacology,
FM, Kelaniya
https://drive.google.com/file/d/1T3c8GKO2uJ-eyv5pYDl0xNBoaakuZOJ2/view?usp=sharing
Introduction to GCP
Principles
What is GCP?
Need for GCP?
Prof Priyadarshani Galappaththy
Professor in Pharmacology
FM, Colombo
https://drive.google.com/file/d/11mVBNO7feFe0nWDlSusvX2eePJPFaTdu/view?usp=sharing
Investigational products
Prof Shalini Sri Ranganathan
Professor in Pharmacology
FM, Colombo
https://drive.google.com/file/d/1HM5mWScbm-paGrtoOCfq0qKRN1O0WqKe/view?usp=sharing
Role and Responsibilities of PI
Dr W S Santharaj
Consultant Cardiologist
Institute of Cardiology
https://drive.google.com/file/d/1NKVrorBiBF-T3TGwnVti5KytU0_fr1E_/view?usp=sharing
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/1WTHe1ATjib2M6de8nz_WlBCLvbje1w-k/view?usp=sharing
Clinical Trials Worldwide
Prof Vajira Dissanayake
Professor in Anatomy, FM, Colombo
Board member, FERCAP
https://drive.google.com/file/d/1oHAUWn_Lz2TDjCLLin9xmUg12Ldnd08a/view?usp=sharing
Day 2 – 4th November 2016
Clinical Trial protocol and IB
Dr Nirmala Wijekoone
Senior Lecturer in Pharmacology, FMS, USJ
https://drive.google.com/file/d/1DfG-P8OHZNCrRvLtuYeeX3KBQjJ8zD3e/view?usp=sharing
Participant safety and adverse effects
Prof Rohini Frenandopulle
Senior Professor in Pharmacology, KDU
https://drive.google.com/file/d/1NGTFs9dzM4jg08u8Yrh8lf99FAPH5NxQ/view?usp=sharing
Documentation & record keeping
Dr G R Constantine
Senior Lecturer in Clinical Medicine, FM, Colombo
https://drive.google.com/file/d/10CMfRB8vViYeAF5Vi4xuOqJ4LnCuj5Ef/view?usp=sharing
Conflict of Interest in Research
Research Integrity _ Malpractice
Dr Malik Fernando
ERC, SLMA
https://drive.google.com/file/d/1WdkLIutLEgE_LrcP29v43N_J-hce_wRV/view?usp=sharing
https://drive.google.com/file/d/1lLleNBYfNH9_igErkANW-H3coPfie1P3/view?usp=sharing
Informed consent
Dr Nilakshi Samaranayake
Senior Lecturer, FMS, Colombo
https://drive.google.com/file/d/1ULjp2OhwEuRRW1ctyuAMNz9TR5RlpSsm/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/1Pg1tUW2kTgugyIGnw8lxXXHcBXJMuwaO/view?usp=sharing