Category: Training Programmes & Workshops
Basics of Research Ethics 2023
Participation Certificate
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Date: 09th November 2023
Time: 09:00 – 11:30
Venue: Virtual
Resource Persons:
Professor Chandanie Wangatunge
President, FERCSL &
Professor Of Pharmacology
Faculty of Medical Sciences, University of Sri Jayawardenepura
Dr. Mizaya Cader
Consultant Community Physician
Ministry of Health
Professor Naazima Kamardeen
Professor of Commercial Law,
University of Colombo
GCP Workshop 2023
Date: 10th August 2023
Venue : SLMA Auditorium
GCP Workshop Agenda
List of participants
Your can get your certificate number from the below list > List
GCP Workshop 2021
Certificate of Participation
The Agenda
(2 pages)
List of participants
Your can get your certificate number from the below list.
Read moreGCP Workshop for Researchers 2018
Date: 12th & 13th June 2018
time: 9.00am
Venue: Lionel Memorial Auditorium, Sri Lanka Medical Association, No 6, Wijerama Mawatha, Colombo
Programme
Day 1: 12th June 2018
Introduction
President FERCSL
Introduction to GCP, Principles. What is GCP? Need for GCP?
Prof Priyadarshani Galappaththy
Professor in Pharmacology
FM, Colombo
https://drive.google.com/file/d/1Ro67fvNQ_OZzBcT5WtFjB6uKWqIaX6Q3/view?usp=sharing
Role and Responsibilities of PI
Prof Priyadarshani Galappaththy
Professor in Pharmacology
FM, Colombo
https://drive.google.com/file/d/1Itu-H_wOQ0bNaGOBKdbvHe3BpH7TXaE9/view?usp=sharing
Drug development process
Dr Channa Ranasinha
Senior Lecturer in Pharmacology,
FM, Kelaniya
https://drive.google.com/file/d/1VhLDG1w0aHkj6kPX-kMlUJ1St-8pzQvA/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/12yGio1fsDAvcsVdWJkPRkqIICUDkOLSI/view?usp=sharing
Clinical Trial protocol and Investigation Brochure
Prof G R Constantine
Professor in Clinical Medicine,
FM, Colombo
https://drive.google.com/file/d/1LdBZxvAA8ufQmPQlsy_dIKU-vmcSVGTy/view?usp=sharing
Participant safety and adverse effects
Prof Shalini Sri Ranganathan
Professor in Pharmacology
FM, Colombo
https://drive.google.com/file/d/1OsIYV_MRp1n9KAeX1-aPaQtf0eNvirYW/view?usp=sharing
Documentation and record keeping
Dr Noel Somasundaram
Consultant Endocrinologist
https://drive.google.com/file/d/1S4Z04qAEDVN7rSrDKNewqoFrvQzsxtwy/view?usp=sharing
Day 2 – 13th June 2018
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/1lnO5RMnjYLNl3ZMKmaXkyDI0gDzLjPns/view?usp=sharing
Informed consent
Dr Manori Gamage
Senior Lecturer, FMS, USJ
https://drive.google.com/file/d/1T_dKUE0rzTkCN8tcp-eJhXhWt0a2WDKA/view?usp=sharing
Research ethics in Clinical Trials
Prof. Chandanie Wanigatunge
Chairperson, FERCSL
Chairperson, ERC SLMA
https://drive.google.com/file/d/11u62rMNTJdK_EebAlGeKYLBc1udeJ4Jf/view?usp=sharing
Investigational products
Prof Shalini Sri Ranganathan
Professor in Pharmacology
FM, Colombo
https://drive.google.com/file/d/1jiHWmZ1f7LDUoK1RfxxsMJGNYpuQbNWg/view?usp=sharing
Role of the sponsor & Contract Research Organization (CRO)
Prof Asitha de Silva
Senior Professor of Pharmacology,
FM, University of Kelaniya
https://drive.google.com/file/d/1v0CY5c_iWKRHhpjRr5V0rlY7c0TEFR7L/view?usp=sharing
Research Misconduct and Conflict of Interest
Dr Malik Fernando
ERC, SLMA
https://drive.google.com/file/d/1c5LhATYyJf30Y3Z9NehjVho_Mbvo3w-X/view?usp=sharing
Dilemmas in Ethics
Date: 14th May 2018
Venue: Lionel Memorial Auditorium, SLMA
Time: 9 am to 12.30 pm
Programme
| Time | Title | Discussion |
| 8.30 – 9.00 am | Registration | |
| 9.00 – 9.15 am | Introduction and instructions | Professor Chandanie Wanigatunge |
| 9.15 – 10.00 am | Group work | |
| 10.00 – 10.15 am | Tea | |
| 10.15 – 10.45 am | Establishing registries | Presented by Group 1 Discussion lead by Dr Jayanie Weeratne Professor Chandanie Wanigatunge ( Sri Lanka Medical Association ) |
| 10.45 – 11.00 am | Ethical Issues related to studies on herbal medicine | Presented by Group 2 Discussion lead by Dr.Vajira Seneviratne Professor Renu Wickramasinghe (Faculty of Medical Sciences, USJ) |
| 11.00 – 11.30 am | Analysis of genomic variations and population history among two major ethnic groups and Vedda population in Sri Lanka | Presented by Group 3 Discussion lead by Dr. Panduka Karunanayake (Faculty of Medicine, University of Colombo) |
| 11.30 – 12.00 pm | HIV screening | Presented by Group 4 Discussion lead by Faculty of Medicine, University of Jaffna |
| 12.00 – 12.30 pm | Studies that involve development and validation of tools | Presented by Group 5 Discussion lead by Prof Sureka Chackrewarthy (Faculty of Medicine, University of Kelaniya) |
GCP workshop for Researchers 2017
Date: 1st & 2nd November 2017
time: 8.30am
Venue: Lionel Memorial Auditorium, Sri Lanka Medical Association, No 6, Wijerama Mawatha, Colombo
Programme
Day 1: 1 st November 2017
Introduction
President SLMA
Introduction to GCP
Principles
What is GCP?
Need for GCP?
Prof Priyadarshani Galappaththy
Professor in Pharmacology
FM, Colombo
Drug development process
Dr Channa Ranasinha
Senior Lecturer in Pharmacology,
FM, Kelaniya
Investigational products
Prof Shalini Sri Ranganathan
Professor in Pharmacology
FM, Colombo
Clinical Trial protocol and IB
Dr Nirmala Wijekoone
Senior Lecturer in Pharmacology, FMS, USJ
Role and Responsibilities of PI
Dr Noel Somasundaram
Consultant Endocrinologist
Regulatory requirements for clinical trials and legal frame work
Mr Arjuna Pathmaperuma
Regulatory Pharmacist
NMDRA/ SCOCT
Role of the sponsor & CRO
Prof Vajira Dissanayake
Professor of Anatomy, FM, Colombo
Board member, FERCAP
Day 2 – 2 nd November 2017
Participant safety and adverse effects
Prof Shalini Sri Ranganathan
Professor in Pharmacology
FM, Colombo
Documentation & record keeping
Prof G R Constantine
Professor in Clinical Medicine, FM, Colombo
Research ethics in Clinical Trials
Prof Chandanie Wanigatunge
Chairperson, FERCSL
Chairperson, ERC SLMA
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
Research misconduct and COI
Dr Malik Fernando
ERC, SLMA
Informed consent
Dr Manouri Gamage
Senior Lecturer, FMS, USJ
Ethics Workshop for Researchers
Date: 22nd June 2017
Start time: 8.30 am
Venue: FGS, University of Moratuwa
Programme
Research Ethics: Fundamentals & Guidelines
Prof. Chandanie Wanigatunge,
Professor of Pharmacology, FMS USJ. Chairperson, FERCSL
https://drive.google.com/file/d/1s49oQNSdMGcUQIJLFQtsVQ7BKy6CE9Yz/view?usp=sharing
Ethics of Qualitative Research
Dr.Shamini Prathapan,
Senior Lecturer in Community Medicine, FMS USJ
https://drive.google.com/file/d/14FPNVDHxj79nhctdZ-0CZ9cEcSdxRSLO/view?usp=sharing
Ethics in Clinical Trials
Prof. Chandanie Wanigatunge,
Professor of Pharmacology, FMS USJ. Chairperson, FERCSL
https://drive.google.com/file/d/1QwbgtM2S-yXSO0JvinpK-_Q1r36g1z_6/view?usp=sharing
Ethics Resources and Guidelines – June 2014
https://drive.google.com/file/d/1xoifQM4IrRTJkv_MzITkZVawiTW8_6nz/view?usp=sharing
Ethics in Social Science Research
Prof Amala de Silva,
Professor in Economics, University of Colombo
https://drive.google.com/file/d/1WYW0Agq10AUKo7kZNPGHYiieDcO0f6N-/view?usp=sharing
Animals in Research
Mayuri Thammitiyagodage. BVSc, MPhil
Veterinary Surgeon
Member Ethics Committee, MRI
Member Ethics Committee, SLMA.
https://drive.google.com/file/d/1msqr7W1bFAzjW0W2kG5IB5eXFs76pB_P/view?usp=sharing
Human Research Ethics in Engineering and Spatial Planning
https://drive.google.com/file/d/1spw3_HYFzUAVW5I2bDoNE4Y2Ga07Q3Lr/view?usp=sharing
Ethics in Legal Research
Dinesha Samararatne
Dept of Public & International Law,
Faculty of Law, University of Colombo
https://drive.google.com/file/d/1_s9sbIPgB-_yJH0gf9LcTSy7TDni3mDE/view?usp=sharing
Research Ethics Involving the Military
Lt. Col. (Dr.) A. Balasuriya
Dean, Faculty of Allied Health Sciences, KDU
Member, KDU ERC & FERCSL
https://drive.google.com/file/d/1jpGwckDghsIIla91kPgzbS61OGsSrxjx/view?usp=sharing
Ethical issues in Paediatric Health Research
Date: 19th June 2017
Start time: 8.30 am
Venue: Lionel Memorial Auditorium, SLMA
Programme
Opening remarks
Prof. C. Wijeyaratne, President, SLMA
Outline
Professor Shalini Sri Ranganathan
Member, ERC/SLMA and Clinical Trial Subcommittee/ Faculty of Medicine, Colombo, Section Editor/ Ceylon Medical Journal
Do we need research in children and are they vulnerable?
Dr.B.J.C.Perera
Specialist Consultant Paediatrician and Honorary Senior Fellow (PGIM),
Joint Editor, Sri Lanka Journal of Child Health
https://drive.google.com/file/d/1Tno94yEppag6AfpTam_KPr3Wrw9nfBcq/view?usp=sharing
Ethical issues in experimental studies in children
Professor Shalini Sri Ranganathan
Member, ERC/SLMA and Clinical Trial Subcommittee/ Faculty of Medicine, Colombo,
Section Editor/ Ceylon Medical Journal
https://drive.google.com/file/d/1JGcpFV4k6_pZd-TA9RawqJL_2Wiu0XGK/view?usp=sharing
Ensuring autonomy: Assent, dissent and consent in paediatric researches
Professor Chandanie Wanigatunge
Chairperson, FERCSL,
Chairperson, SLMA ERC
https://drive.google.com/file/d/1oRSYvTOY8nhocbJV3hGDqlnl0Zf_wYma/view?usp=sharing
Risk Vs. Benefit assessment in studies involving children
Dr. Jithangi Wanigasinghe
Senior Lecturer and Consultant Paediatric Neurologist
https://drive.google.com/file/d/1k7tcKVlOmSgjlwfiG1kNFuapxuPJWEJd/view?usp=sharing
Ethical issues in observational studies in children
Dr Gitanjali Sathiadas
Senior Lecturer In Paediatrics and Consultant Paediatrician
https://drive.google.com/file/d/19UHGMDiodVXFHubb0sBs8T4BzVk0Tpvz/view?usp=sharing
Roles of Ethics Review Committees and researchers in ensuring ethical health research in children
Resource persons and participants
GCP Workshop for Researchers 2016
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