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2019 GMS5101 Clinical Trial Design and Data Analysis

The effective regulation of pharmaceuticals for safety and efficacy depends on the availability, understanding and appropriate implementation of relevant guidelines and the processes designed to ensure quality in decision-making. The requirements are frequently different from traditional clinical trials and specific to regulatory affairs. This four-credit module provides the understanding for the unique requirements of clinical trials and clinical data meant to support regulatory evaluation and approvals.

Due to the limited availability of seats, early registration is strongly recommended.
 
 
 

 

 

 

about singapore   

Date and Time

08 Jul 2019 @ 08:30 - 12 Jul 2019 @ 17:30

Registration

Registration is closed

Speaker

Herve Le Louet

Prof Hervé LeLouet

President 
CIOMS

Carole Legare

Dr Carole Légaré

Director 
Office of Clinical Trials 
Therapeutic Products Directorate 
Health Canada

Jing Ping Yeo

Dr Yeo Jing Ping

Director 
Research Integrity, Compliance and Ethics 
Singapore Health Services Ptd Ltd (SingHealth)


Foo Yang Tong

Mr Foo Yang Tong

Director
Regulatory Legislation Group
Director's Office
Health Sciences Authority

Daphne Lin

Dr Daphne Lin

Deputy Director
Division of Biometrics IV
Office of Biostatistic
Center for Drug Evaluation and Research
U.S. Food and Drug Administration (US FDA)

Brian Booth

Dr Brian Booth

Deputy Director
Division of Clinical Pharmacology V
Office of Clinical Pharmacology
Center for Drug Evaluation and Research
U.S. Food and Drug Administration (FDA)

Robert Kerle

Mr Robert Kerle

Head
R&D Solutions Southeast Asia
IQVIA 

LEE Edmund

Prof Edmund Lee

Department of Pharmacology
Yong Yoo Lin School of Medicine (YYLSoM)

Liza Huang

Ms Liza Huang

Deputy Head
Clinical Operations 
Boehringer Ingelheim 

Sumitra SACHIDANANDAN

Ms Sumitra Sachidanandan

Regulatory Consultant
Innovation Office and Clinical Trials Branch
Health Products Regulation Group
Health Sciences Authority

Cynthia Sung

Adj A/Prof Cynthia Sung

Visiting Expert, CoRE
Duke-NUS Medical School