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



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