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



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