GCP Workshop for Researchers 2016

posted Oct 2, 2016, 7:18 PM by Prasad Ranatunga   [ updated Nov 10, 2016, 7:29 PM by FERCSL Editor ]
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

9.00 am - 9.15 am
Introduction
Dr Malik Fernando 
FERCSL MC

9.15 am - 10.00 am
History of research ethics in Clinical Trials
Prof. Chandanie Wanigatunge
Professor of Pharmacology, FMS USJ
Secretary, ERC SLMA
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10.00 am - 10.15 am
Tea

10.15am  - 11.00 am
Drug development process
Dr Channa Ranasinha
Senior Lecturer in Pharmacology,
FM, Kelaniya
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11.00 am – 11. 45 am
Introduction to GCP
Principles
What is GCP?
Need for GCP?
Prof Priyadarshani Galappaththy
Professor in Pharmacology
FM, Colombo
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11.45 am to 12.30 pm
Investigational products
Prof Shalini Sri Ranganathan
Professor in Pharmacology
FM, Colombo
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12.30 pm – 1.15 pm
Lunch


1.15 pm – 2.00 pm
Role and Responsibilities of PI
Dr W S Santharaj
Consultant Cardiologist
Institute of Cardiology
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2.00 pm -2.45 pm
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
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2.45 pm - 3.30pm
Role of the sponsor & CRO
Prof Vajira Dissanayake
Professor in Anatomy, FM, Colombo
Board member, FERCAP
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Day 2 – 4th November 2016


9.00 am  – 9.45 am
Clinical Trial protocol and IB
Dr Nirmala Wijekoone
Senior Lecturer in Pharmacology, FMS, USJ
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9.45 am – 10.30 am
Participant safety and adverse effects
Prof Rohini Frenandopulle
Senior Professor in Pharmacology, KDU
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10.30 am - 10.45 am
Tea

10.45  am – 11.30 am
Documentation & record keeping
Dr G R Constantine
Senior Lecturer in Clinical Medicine, FM, Colombo
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11.30 am – 12.15pm
Research misconduct and COI
Dr Malik Fernando
ERC, SLMA
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12.15 pm – 12.45 pm
Informed consent
Dr Nilakshi Samaranayake
Senior Lecturer, FMS, Colombo
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12.45 pm – 1.30 pm
Regulatory requirements for clinical trials and legal frame work
Mr Arjuna Pathmaperuma
Regulatory Pharmacist
NMDRA/ SCOCT
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Nov 6, 2016, 8:22 AM
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Nov 6, 2016, 8:28 AM
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