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Training Programmes & Workshops


GCP Workshop for Researchers 2018

posted May 28, 2018, 7:43 PM by FERCSL Editor   [ updated Jun 15, 2018, 11:49 AM ]

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

Time

Topic

Speaker

9.00 am - 9.15 am

Introduction

President FERCSL

9.15 am - 10.00 am

Introduction to GCP

Principles     

What is GCP?

Need for GCP?

Prof Priyadarshani Galappaththy

Professor in Pharmacology

FM, Colombo

01-Introduction to GCP Principles.pdf

10.00 am - 10.15 am

Tea

10.15am  - 11.00 am

Role and Responsibilities of PI

Prof Priyadarshani Galappaththy

Professor in Pharmacology

FM, Colombo

02-Role and Responsibilities of PI.pdf

11.00 am – 11. 45 am

Drug development process

Dr Channa Ranasinha

Senior Lecturer in Pharmacology,

FM, Kelaniya

03-Drug Development Process

11.45 am to 12.30 pm

Regulatory requirements for clinical trials and legal frame work

Mr Arjuna Pathmaperuma

Regulatory Pharmacist

NMDRA/ SCOCT

04-Regulatory requirements for clinical trials and legal frame work.pdf

12.30 pm – 1.15 pm

Lunch

1.15 pm – 2.00 pm

Clinical Trial protocol and Investigation Brochure

Prof G R Constantine

Professor in Clinical Medicine, 

FM, Colombo

05-Clinical Trial protocol and Investigation Brochure.pdf

2.00 pm -2.45 pm

Participant safety and adverse effects

Prof Shalini Sri Ranganathan

Professor in Pharmacology

FM, Colombo

06-Participant Safety and Adverse Effects.pdf

2.45 pm - 3.30pm

Documentation and record keeping

Dr Noel Somasundaram

Consultant Endocrinologist

07-Documentation and record keeping.pdf

 

Day 2 – 13th June 2018

Time

Topic

Speaker

9.00 am  – 9.45 am

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

08-Ethics review committee function, with special reference to GCP and Clinical Trials .pdf

9.45 am – 10.30 am

Informed consent

Dr Manouri Gamage

Senior Lecturer, FMS, USJ

09-Informed consent.pdf

10.30 am – 11.00 am

Research ethics in Clinical Trials

Prof. Chandanie Wanigatunge

Chairperson, FERCSL

Chairperson, ERC SLMA

10-Research ethics in Clinical Trials.pdf

11.00 am – 11.15 am

Tea

11.15  am – 11.45 am

Investigational products

Prof Shalini Sri Ranganathan

Professor in Pharmacology

FM, Colombo

11-Investigational Products.pdf

11.45 am – 12.15pm

Role of the sponsor & Contract Research Organization (CRO)

Prof Asitha de Silva

Senior Professor of Pharmacology, 

FM, University of Kelaniya

12-Role of the sponsor & Contract Research Organization.pdf

12.15 pm – 12.45 pm

Research Misconduct and Conflict of Interest

Dr Malik Fernando
ERC, SLMA

13-Research Misconduct and Conflict of Interest.pdf



Photo Gallery


Dilemmas in Ethics

posted May 28, 2018, 7:31 PM by FERCSL Editor   [ updated Jun 15, 2018, 11:52 AM ]

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

9.00 – 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

   Prof.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)


Photo Gallery


GCP workshop for Researchers 2017

posted Sep 27, 2017, 12:42 AM by Prasad Ranatunga   [ updated Nov 1, 2017, 9:09 PM by FERCSL Editor ]

Date: 1st & 2nd November 2017
time: 8.30am
Venue: Lionel Memorial Auditorium, Sri Lanka Medical Association, No 6, Wijerama Mawatha, Colombo 

Programme

Day 1: 1st November 2017

Time

Topic

Speaker

9.00 am - 9.15 am

Introduction

President SLMA

9.15 am - 10.00 am

 

Introduction to GCP

Principles     

What is GCP?

Need for GCP?

Prof Priyadarshani Galappaththy

Professor in Pharmacology

FM, Colombo

0718655651

10.00 am - 10.15 am

Tea

10.15am  - 11.00 am

Drug development process

Dr Channa Ranasinha

Senior Lecturer in Pharmacology,

FM, Kelaniya

11.00 am – 11. 45 am

Investigational products

Prof Shalini Sri Ranganathan
Professor in Pharmacology

FM, Colombo

11.45 am -12.30 pm

Clinical Trial protocol and IB

Dr Nirmala Wijekoone

Senior Lecturer in Pharmacology, FMS, USJ

12.30 pm – 1.15 pm

Lunch

 

1.15 pm – 2.00 pm

Role and Responsibilities of PI

Dr Noel Somasundaram

Consultant Endocrinologist

2.00 pm -2.45 pm

Regulatory requirements for clinical trials and

legal frame work

Mr Arjuna Pathmaperuma

Regulatory Pharmacist

NMDRA/ SCOCT

2.45 pm - 3.30pm

Role of the sponsor & CRO

Prof Vajira Dissanayake
Professor of Anatomy, FM, Colombo

Board member, FERCAP

Day 2 – 2nd November 2017

Time

Topic

Speaker

9.00 am  – 9.45 am

Participant safety and adverse effects

Prof Shalini Sri Ranganathan
Professor in Pharmacology

FM, Colombo

9.45 am – 10.30 am

Documentation & record keeping

Prof G R Constantine

Professor in Clinical Medicine, FM, Colombo

10.30 am – 11.00 am

Research ethics in Clinical Trials

Prof. Chandanie Wanigatunge

Chairperson, FERCSL

Chairperson, ERC SLMA

11.00 am – 11.15 am

Tea

 

11.15  am – 11.45 am

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

11.45 am – 12.15pm

Research misconduct and COI

Dr Malik Fernando
ERC, SLMA

12.15 pm – 12.45 pm

Informed consent

Dr Manouri Gamage

Senior Lecturer, FMS, USJ



Introduction to GCP
Prof Priyadarshani Galappaththy
Professor in Pharmacology
FM, Colombo
https://drive.google.com/open?id=0B7l5JzDnfa5TclFqcHY1ZVc2X0U


Drug development process
Dr Channa Ranasinha
Senior Lecturer in Pharmacology,
FM, Kelaniya
https://drive.google.com/open?id=0B7l5JzDnfa5TQnFsLUNCTWZsTVU


Investigational products
Prof Shalini Sri Ranganathan
Professor in Pharmacology
FM, Colombo
https://4c9497a5-a-62cb3a1a-s-sites.googlegroups.com/site/fercsllk/CmngSn.png?attachauth=ANoY7crDbCXjCS6nI4eodbdhIWGCvGLw_RIRlhwNu-6cSCHTd-U-hOBwuQdSVSS-0kvICHO1FUctuROs_4oR1-rfcDWg_jzOqU8XC0H-vguwW0HRQi_fRuJ81YmgxtQU9mnJdGkVzVfxf9xw4D-u03ow6N4Bb5EXgMctcE03MM6F7yXVQIZ_4-Y0iW4Se93ZtXs99VtRam1zT9O174M6Ob5ET8CG0S3ccQ%3D%3D&attredirects=0


Clinical Trial protocol and IB
Dr Nirmala Wijekoone
Senior Lecturer in Pharmacology, FMS, USJ
https://4c9497a5-a-62cb3a1a-s-sites.googlegroups.com/site/fercsllk/CmngSn.png?attachauth=ANoY7crDbCXjCS6nI4eodbdhIWGCvGLw_RIRlhwNu-6cSCHTd-U-hOBwuQdSVSS-0kvICHO1FUctuROs_4oR1-rfcDWg_jzOqU8XC0H-vguwW0HRQi_fRuJ81YmgxtQU9mnJdGkVzVfxf9xw4D-u03ow6N4Bb5EXgMctcE03MM6F7yXVQIZ_4-Y0iW4Se93ZtXs99VtRam1zT9O174M6Ob5ET8CG0S3ccQ%3D%3D&attredirects=0


Role and Responsibilities of PI
Dr Noel Somasundaram
Consultant Endocrinologist
https://drive.google.com/open?id=0B7l5JzDnfa5TTnp1dTVGRnE5RVU


Regulatory requirements for clinical trials and legal frame work
Mr Arjuna Pathmaperuma
Regulatory Pharmacist
NMDRA/ SCOCT
https://drive.google.com/open?id=0B7l5JzDnfa5TN29fNzdfbmVSWmc


Role of the sponsor & CRO
Prof Vajira Dissanayake
Professor of Anatomy, FM, Colombo
Board member, FERCAP
https://4c9497a5-a-62cb3a1a-s-sites.googlegroups.com/site/fercsllk/CmngSn.png?attachauth=ANoY7crDbCXjCS6nI4eodbdhIWGCvGLw_RIRlhwNu-6cSCHTd-U-hOBwuQdSVSS-0kvICHO1FUctuROs_4oR1-rfcDWg_jzOqU8XC0H-vguwW0HRQi_fRuJ81YmgxtQU9mnJdGkVzVfxf9xw4D-u03ow6N4Bb5EXgMctcE03MM6F7yXVQIZ_4-Y0iW4Se93ZtXs99VtRam1zT9O174M6Ob5ET8CG0S3ccQ%3D%3D&attredirects=0


Participant safety and adverse effects
Prof Shalini Sri Ranganathan
Professor in Pharmacology
FM, Colombo
https://4c9497a5-a-62cb3a1a-s-sites.googlegroups.com/site/fercsllk/CmngSn.png?attachauth=ANoY7crDbCXjCS6nI4eodbdhIWGCvGLw_RIRlhwNu-6cSCHTd-U-hOBwuQdSVSS-0kvICHO1FUctuROs_4oR1-rfcDWg_jzOqU8XC0H-vguwW0HRQi_fRuJ81YmgxtQU9mnJdGkVzVfxf9xw4D-u03ow6N4Bb5EXgMctcE03MM6F7yXVQIZ_4-Y0iW4Se93ZtXs99VtRam1zT9O174M6Ob5ET8CG0S3ccQ%3D%3D&attredirects=0


Documentation & record keeping
Prof G R Constantine
Professor in Clinical Medicine, 
FM, Colombo
https://4c9497a5-a-62cb3a1a-s-sites.googlegroups.com/site/fercsllk/CmngSn.png?attachauth=ANoY7crDbCXjCS6nI4eodbdhIWGCvGLw_RIRlhwNu-6cSCHTd-U-hOBwuQdSVSS-0kvICHO1FUctuROs_4oR1-rfcDWg_jzOqU8XC0H-vguwW0HRQi_fRuJ81YmgxtQU9mnJdGkVzVfxf9xw4D-u03ow6N4Bb5EXgMctcE03MM6F7yXVQIZ_4-Y0iW4Se93ZtXs99VtRam1zT9O174M6Ob5ET8CG0S3ccQ%3D%3D&attredirects=0


Research ethics in Clinical Trials
Prof. Chandanie Wanigatunge
Chairperson, FERCSL
Chairperson, ERC SLMA
https://drive.google.com/open?id=0B7l5JzDnfa5TY19jc2h5SjBYcW8


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://4c9497a5-a-62cb3a1a-s-sites.googlegroups.com/site/fercsllk/CmngSn.png?attachauth=ANoY7crDbCXjCS6nI4eodbdhIWGCvGLw_RIRlhwNu-6cSCHTd-U-hOBwuQdSVSS-0kvICHO1FUctuROs_4oR1-rfcDWg_jzOqU8XC0H-vguwW0HRQi_fRuJ81YmgxtQU9mnJdGkVzVfxf9xw4D-u03ow6N4Bb5EXgMctcE03MM6F7yXVQIZ_4-Y0iW4Se93ZtXs99VtRam1zT9O174M6Ob5ET8CG0S3ccQ%3D%3D&attredirects=0


Research misconduct and COI
Dr Malik Fernando
ERC, SLMA
https://drive.google.com/open?id=0B7l5JzDnfa5TY1RuYXE1aUI0aEk


Informed consent
Dr Manouri Gamage
Senior Lecturer, FMS, USJ
https://4c9497a5-a-62cb3a1a-s-sites.googlegroups.com/site/fercsllk/CmngSn.png?attachauth=ANoY7crDbCXjCS6nI4eodbdhIWGCvGLw_RIRlhwNu-6cSCHTd-U-hOBwuQdSVSS-0kvICHO1FUctuROs_4oR1-rfcDWg_jzOqU8XC0H-vguwW0HRQi_fRuJ81YmgxtQU9mnJdGkVzVfxf9xw4D-u03ow6N4Bb5EXgMctcE03MM6F7yXVQIZ_4-Y0iW4Se93ZtXs99VtRam1zT9O174M6Ob5ET8CG0S3ccQ%3D%3D&attredirects=0



Ethics Workshop for Researchers

posted Jun 24, 2017, 11:14 AM by FERCSL Editor   [ updated Jun 25, 2017, 7:42 AM ]

Date: 22nd June 2017
Start time: 8.30 am
Venue: FGS, University of Moratuwa

Programme

Time

Topic

Speaker

8.30am

Registration

 

8.55am

Opening Remarks

 

9.00am- 9.30am

Research Ethics: Fundamentals & Guidelines

 

Prof. Chandanie Wanigatunge, Professor of Pharmacology, FMS USJ.   Chairperson, FERCSL

 

Ethics of Qualitative Research

 

Dr.Shamini Prathapan, Senior Lecturer in Community Medicine, FMS USJ

10.15 am - 10.30 am

                         Tea

 

10.30 am – 11.15 pm

 

What ERCs consider in Biomedical Research

Prof. Chandanie Wanigatunge, Professor of Pharmacology, FMS USJ.   Chairperson, FERCSL

11.15-pm-12.00 pm

Ethics in Social Science Research

 

Prof Amala de Silva, Professor in Economics, University of Colombo

 

Closing Remarks

 

 

Lunch

 

 

Research Ethics: Fundamentals & Guidelines
Prof. Chandanie Wanigatunge, 
Professor of Pharmacology, FMS USJ. Chairperson, FERCSL
https://docs.google.com/viewer?a=v&pid=sites&srcid=ZGVmYXVsdGRvbWFpbnxmZXJjc2xsa3xneDo5YWU5MWJiY2I5NWVmN2U


Ethics of Qualitative Research 
Dr.Shamini Prathapan, 
Senior Lecturer in Community Medicine, FMS USJ
https://docs.google.com/viewer?a=v&pid=sites&srcid=ZGVmYXVsdGRvbWFpbnxmZXJjc2xsa3xneDoxOTUzYmE2YTYyMzU0Y2Mx


What ERCs consider in Biomedical Research
Prof. Chandanie Wanigatunge, 
Professor of Pharmacology, FMS USJ. Chairperson, FERCSL
https://docs.google.com/viewer?a=v&pid=sites&srcid=ZGVmYXVsdGRvbWFpbnxmZXJjc2xsa3xneDoxYzVjZjljY2VhZTkxMDM3


Ethics in Social Science Research 
Prof Amala de Silva, 
Professor in Economics, University of Colombo
https://docs.google.com/viewer?a=v&pid=sites&srcid=ZGVmYXVsdGRvbWFpbnxmZXJjc2xsa3xneDpkMDc5YjMyNWFjNTYzYWM

Ethical issues in Paediatric Health Research

posted May 30, 2017, 10:11 AM by FERCSL Editor   [ updated Jun 25, 2017, 7:41 AM ]

Date: 19th June 2017
Start time: 8.30 am
Venue: Lionel Memorial Auditorium, SLMA

Programme 

Time

Topic

Speaker

8.30 am

Registration

 

8.55 am

Opening remarks

Prof. C. Wijeyaratne, President, SLMA

9.00 am - 9.15 am

Outline

Professor Shalini Sri Ranganathan

Member, ERC/SLMA and Clinical Trial Subcommittee/ Faculty of Medicine, Colombo, Section Editor/ Ceylon Medical Journal

9.15 am - 10.00 am

 

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

10.00 am -10.45 am

 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

10.45 am – 11.00 am

Tea

11.00 am  - 11.45 am

 

Ensuring autonomy: Assent, dissent and consent in paediatric researches

Professor Chandanie Wanigatunge

Chairperson, FERCSL,

Chairperson, SLMA ERC

11.45 am – 12.30 pm

Risk Vs. Benefit assessment in studies involving children

Dr. Jithangi Wanigasinghe

Senior Lecturer and Consultant Paediatric Neurologist

12.30 pm – 1.15 pm

Ethical issues in observational studies in children

Dr Gitanjali Sathiadas

Senior Lecturer In Paediatrics and Consultant Paediatrician

1.15 pm – 1.30 pm

 Roles of Ethics Review Committees and researchers in ensuring ethical health research in children

 Resource persons and participants



Outline
Professor Shalini Sri Ranganathan
Member, ERC/SLMA and Clinical Trial Subcommittee/ Faculty of Medicine, Colombo, Section Editor/ Ceylon Medical Journal
https://docs.google.com/viewer?a=v&pid=sites&srcid=ZGVmYXVsdGRvbWFpbnxmZXJjc2xsa3xneDo0NjJhZmQ3MGI5YzU5MmQ4

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

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://docs.google.com/viewer?a=v&pid=sites&srcid=ZGVmYXVsdGRvbWFpbnxmZXJjc2xsa3xneDozOGFmOTAxYjNjNzM0NWM1

Ensuring autonomy: Assent, dissent and consent in paediatric researches
Professor Chandanie Wanigatunge
Chairperson, FERCSL, 
Chairperson, SLMA ERC
https://docs.google.com/viewer?a=v&pid=sites&srcid=ZGVmYXVsdGRvbWFpbnxmZXJjc2xsa3xneDo2NDc3YWVjNzI1ZWIxZWFi

Risk Vs. Benefit assessment in studies involving children
Dr. Jithangi Wanigasinghe
Senior Lecturer and Consultant Paediatric Neurologist
https://docs.google.com/viewer?a=v&pid=sites&srcid=ZGVmYXVsdGRvbWFpbnxmZXJjc2xsa3xneDo1N2FjN2E2OTMzMzJmM2Rm

Ethical issues in observational studies in children
Dr Gitanjali Sathiadas
Senior Lecturer In Paediatrics and Consultant Paediatrician
https://docs.google.com/viewer?a=v&pid=sites&srcid=ZGVmYXVsdGRvbWFpbnxmZXJjc2xsa3xneDo3OWNjMGJiMTUwMjY3MmYx

Ethics Workshop for Researchers 2017

posted Apr 24, 2017, 8:30 AM by FERCSL Editor   [ updated Apr 25, 2017, 7:29 AM ]

Date : 22nd April 2017
Start Time : 8.30 am
Venue : FGS, KDU

Programme


Fundamentals of Research Ethics &Guidelines
Prof. Chandanie Wanigatunge
Professor of Pharmacology, FMS USJ
Chairperson, FERCSL
download

Ethics in Animal Research
Dr. Mayuri Thammitiyagodage,
MRI, Colombo
download

Human Research Ethics in Engineering and Spatial Planning
Dr. Rangajeewa Ratnayake
Head, Department of Town and Country Planning, University of Moratuwa
download

Ethics in Clinical Trials
Prof. Chandanie Wanigatunge
Professor of Pharmacology, FMS USJ
Chairperson, FERCSL
download

Ethics in Qualitative Research
Dr.Shamini Prathapan
Senior Lecturer in Community Medicine, FMS USJ
download

Ethics in Social Science Research
Prof Amala de Silva
Professor in Economics, University of Colombo
download

Legal Research and Ethics
Dr. Dinesha Samararatne
Senior Lecturer, Dept of Public & International Law, Faculty of Law, University of Colombo
download
Ethics Resources and Guidelines
download

Research ethics involving the military
Dr A. Balasuriya
Dean, Faculty of Allied Health sciences, KDU
download

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
download

10.00 am - 10.15 am
Tea

10.15am  - 11.00 am
Drug development process
Dr Channa Ranasinha
Senior Lecturer in Pharmacology,
FM, Kelaniya
download

11.00 am – 11. 45 am
Introduction to GCP
Principles
What is GCP?
Need for GCP?
Prof Priyadarshani Galappaththy
Professor in Pharmacology
FM, Colombo
download

11.45 am to 12.30 pm
Investigational products
Prof Shalini Sri Ranganathan
Professor in Pharmacology
FM, Colombo
download

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
download

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
download

2.45 pm - 3.30pm
Role of the sponsor & CRO
Prof Vajira Dissanayake
Professor in Anatomy, FM, Colombo
Board member, FERCAP
download

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
download

9.45 am – 10.30 am
Participant safety and adverse effects
Prof Rohini Frenandopulle
Senior Professor in Pharmacology, KDU
download

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
download

11.30 am – 12.15pm
Research misconduct and COI
Dr Malik Fernando
ERC, SLMA
download

12.15 pm – 12.45 pm
Informed consent
Dr Nilakshi Samaranayake
Senior Lecturer, FMS, Colombo
download

12.45 pm – 1.30 pm
Regulatory requirements for clinical trials and legal frame work
Mr Arjuna Pathmaperuma
Regulatory Pharmacist
NMDRA/ SCOCT
download

Surveying and Evaluating Ethical Review Practices 2016

posted Jun 5, 2016, 10:24 AM by FERCSL Editor   [ updated Oct 30, 2016, 5:40 AM ]

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


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

Photo Gallery



Programme

Research Ethics and the Ethics Review Process
Prof. Vajira H. W. Dissanayake

Risk-Benefit Assessment in a survey
Dr Cristina E. Torres
https://docs.google.com/viewer?a=v&pid=sites&srcid=ZGVmYXVsdGRvbWFpbnxmZXJjc2xsa3xneDoxN2E5YjBlZTI2Mzc2ZTU4

Ethics Review of Academic Research
Dr Cristina E. Torres
https://docs.google.com/viewer?a=v&pid=sites&srcid=ZGVmYXVsdGRvbWFpbnxmZXJjc2xsa3xneDoyYjRlMzY1NzA4NzQwMDZk

Assessment of Quality of Review
Prof. Chandanie Wanigatunge
https://docs.google.com/viewer?a=v&pid=sites&srcid=ZGVmYXVsdGRvbWFpbnxmZXJjc2xsa3xneDo0Zjg2ZDU3ZTUyM2RjOWFj

Woking Groups Practical: Preparing for a site visit
Preparing the Survey Plan
  • Grouping the Surveyors and Trainees
  • Assigning responsibilities to the Survey Groups
  • Selection of persos to be interviewed
  • Selection of Protocols for review

Presentations

A Workshop on Vulnerability and Research Ethics

posted Apr 21, 2016, 10:26 AM by FERCSL Editor   [ updated Oct 30, 2016, 7:34 AM ]

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

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


Photo Gallery


Programme

Overview of vulnerability and Ethics
Professor Chandanie Wanigatunge
Chairperson, FERCSL
..

Research involving those who lack mental capacity to consent
Dr. Jayan Mendis,
Consultant Psychiatrist
NIMH
..

Ethics in Research involving Children
Professor Shalini Sri Ranganathan
Professor in Pharmacology,
Faculty of Medicine
University of Colombo
..

Ethics in Research involving Women
Professor Maithree Wickramasinghe
Professor in English,
Department of English
University of Kelaniya
..


Presentations

Workshop on Evaluation of Research Proposals by ERCs

posted Apr 21, 2016, 10:25 AM by FERCSL Editor

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

Workshop Concluded Successfully

Photo Gallery


Programme

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

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