Date: 10th August 2023
Venue : SLMA Auditorium
The certificates will be available for download only up to 2023-09-17. Please download the certificates before the deadline.
Please identify your certificate number from this list > link to list
Then download your workshop certficate from this folder > link to folder
GCP Workshop Agenda
The Agenda
(2 pages)
GCP-workshop-agenda-2021Your can get your certificate number from the below list.
Read moreDate: 12th & 13th June 2018
time: 9.00am
Venue: Lionel Memorial Auditorium, Sri Lanka Medical Association, No 6, Wijerama Mawatha, Colombo
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
Date: 14th May 2018
Venue: Lionel Memorial Auditorium, SLMA
Time: 9 am to 12.30 pm
| 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) |
Date: 1st & 2nd November 2017
time: 8.30am
Venue: Lionel Memorial Auditorium, Sri Lanka Medical Association, No 6, Wijerama Mawatha, Colombo
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
Date: 22nd June 2017
Start time: 8.30 am
Venue: FGS, University of Moratuwa
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
Date: 19th June 2017
Start time: 8.30 am
Venue: Lionel Memorial Auditorium, SLMA
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
conducted by Forum for Ethical Review Committees in Asia & the Western Pacific (FERCAP)
and Forum for Ethics Review Committees in Sri Lanka (FERCSL)
Date: 5th June 2016
Time: 9:00 to 16:00
Venue: Auditorium, PGIM, University of Colombo
Research Ethics and the Ethics Review Process
Prof. Vajira H. W. Dissanayake
https://drive.google.com/file/d/1oH463qeQ1tIn2M6JhuQYKtCM6UitsTpr/view?usp=sharing
Risk-Benefit Assessment in a survey
Dr Cristina E. Torres
https://drive.google.com/file/d/1sFnLCuyoyhsoh3wmSAYnyM1FZod-Yqrf/view?usp=sharing
Ethics Review of Academic Research
Dr Cristina E. Torres
https://drive.google.com/file/d/1SJ666gKgu5SZlLUqMtUX1HYN-opb54Cp/view?usp=sharing
Assessment of Quality of Review
Prof. Chandanie Wanigatunge
https://drive.google.com/file/d/1WJclrWHnVCV6_d8uOyDuH_GYMv99GRR2/view?usp=sharing
Woking Groups Practical: Preparing for a site visit
Date : 28th March 2016
Time : 8.30 am to 12 noon
Venue : Lionel Memorial Auditorium, Sri Lanka Medical Association, No 6, Wijerama Mawatha, Colombo 7
Overview of vulnerability and Ethics
Professor Chandanie Wanigatunge
Chairperson, FERCSL
https://drive.google.com/file/d/1ZswEKtCiyyqyf0HmNuiTPXr_Y3kubkLu/view?usp=sharing
Research involving those who lack mental capacity to consent
Dr. Jayan Mendis,
Consultant Psychiatrist
NIMH
https://drive.google.com/file/d/1vRbu39EtmKTALy2l7W4C0XwtR12hwDHl/view?usp=sharing
Ethics in Research involving Children
Professor Shalini Sri Ranganathan
Professor in Pharmacology,
Faculty of Medicine
University of Colombo
https://drive.google.com/file/d/1bnpAmcHVq2ZeNjpjoThYrrnTA7abHETK/view?usp=sharing
Ethics in Research involving Women
Professor Maithree Wickramasinghe
Professor in English,
Department of English
University of Kelaniya
https://drive.google.com/file/d/1lqU4v8hYSowt57AH0E1fnFuivre_ow18/view?usp=sharing
Organised by
Ethical Review Committee, Faculty of Medicine, General Sir John Kotelawala Defence University
&
Forum for Ethics Review Committees in Sri Lanka
Date : 16th February 2016
Time : 8.30 am to 1.00 pm
Venue : Staff Development Centre, 5th floor, Faculty of Medicine building, KDU
Welcome Address
Prof. Rohini Fernandopulle
Chairperson, ERC, FoM, KDU
Evaluation of protocols by the ERC
Prof. Shalini Sri Ranganathan
Professor in Pharmacology,
Faculty of Medicine
University of Colombo
Evaluation of Information sheets, consent forms and assent forms
Dr. Malik Fernando
Member,
ERC, Sri Lanka Medical Association
Sociological issues in research proposal evaluation
Dr. Chandani Liyanage
Senior Lecturer,
Department of Sociology
University of Colombo
