1 Opening and Welcome Speech

Topics: Clinical trial, Pharmaceutical industry, Clinical trial protocol Pages: 2 (624 words) Published: July 24, 2015

BANGKOK, 2-6 FEB 2009

Opening and Welcome Speech
Mrs Werawan Tangkeo
The Deputy Secretary General of Thai Food and Drug Administration @ The Siam City Hotel, Bangkok
2-6 February 2009
Dr Viner, Dr Stevens, Dr Sato, and Dr Sudhichai,
Distinguished participants,
Ladies and Gentlemen:
It gives me a great pleasure to welcome all of you and chair the Opening Ceremony this morning to the “Advanced Workshop: Review of Drug Development in Clinical Trials” jointly organized by Asia Pacific Economic Co-operation and Food and Drug Administration, Thailand.

The significance of Drug Clinical Trials and Capacity Building for Drug Regulatory Agencies are well noticed by several international networks including ASEAN or Association of South East Asian Nations, APEC or Asia Pacific Economic Cooperation, and ICH Global Cooperation Group. This project has been endorsed by ASEAN Working Group on Technical Cooperation in Pharmaceutical (AWGTCP), APEC Life Sciences Innovation Forum (LSIF) and ICH Global Cooperation Group (GCG) since the year 2002, 2006 and 2007, respectively. By the listed international cooperation, indeed, we have received technical, financial, and moral supports. Please allow me to recall the last year achievement of hosting 2 training workshops in Thailand, those are “Preliminary Workshop : Review of Drug Development in Clinical Trials” and “Basic Workshop on GCP/ Clinical Research Inspection”. The accomplishments of both mentioned courses have brought to the 2nd project endorsement by APEC in later of the year 2008.

Therefore, Thai FDA again is able to

organize the 2nd or advanced phase of the training courses, which include the advanced course of clinical trial assessment and advanced course of clinical trial inspection. Today’s workshop would include numbers of advanced topics regarding the drug development in clinical trials and their assessments to ensure quality and safety...
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