FOR NANOTECHNOLOGY WORKSHOP IN ENGLISH ONE DAY

Opening and Welcome Speech

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 of the clinical trials and the investigational drugs themselves. This workshop has been designed to
be practical with lectures, examples and exercises to provide skills, encourage participation
and exchange information.
Today’s workshop is attended by 4 speakers representing both leading Drug Regulatory
Agencies and Industries, those are Health Canada, Pharmaceutical and Medical Device
Agency (JAPAN), and Novartis, and officers from Drug Regulatory Authorities of 10 different
economies and country including Brunei, Chile, Indonesia, Malaysia, Peru, Philippines, Saudi
Arabia, Singapore, Chinese Taipei, and Thailand. Therefore, this workshop will provide us
not only essential knowledge but also a great opportunity to share experiences both
technical and regulatory issues
I would like to take this opportunity to express my sincere thanks to the organizers and in
particular our honorable speakers. All of them have been working with us since the
beginning of the planning stage and they are still here today for all of us, even though they
are both very busy with their responsibilities at their agencies. We truly appreciate your
dedication. Again, this training program could not have been made possible without APEC,
ICH, ASEAN, Health Canada, PMDA, and Novartis , who foresee the importance of Clinical
Trial Assessment. I hope that everyone would take the results of this program to develop
our regulatory system to ensure the quality and safety of clinical trials and investigational
products.
Finally, this is an opportune time for me to declare the official opening of the “Advanced
Workshop: Review of Drug Development in Clinical Trials” and I wish all 5 fruitful days of
interesting and beneficial program and also that you have a pleasant stay in Bangkok.
I warmly welcome you again.