Provisional Program
Day 1: Tuesday August 25, 2015
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08.00 - 09.00 am
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Registration
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09.00 - 09.20 am
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Opening remarks from Conference Chairpersons
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09.20 - 10.00 am
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Opening Ceremony: Signed Memorandum of Understand
Thailand FDA, National Science Technology and Innovation Policy office, Regulatory Affairs Pharmacy Association, Thailand Industrial Pharmacist Association, Thai Pharmaceutical Manufacturers Association, Pharmaceutical Research and Manufacturers Association, and Thai Self Medication Industry Association, and Chulalongkorn University |
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10.00 - 10.15 am
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Coffee Break
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10.15 - 11.00 am
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Introduction to Pharmaceutical Medicine
Dr. Yil-Seob LEE, Director, Medical & Regulatory Affairs, GSK Korea |
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11.00 - 11.45 am
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Realisation of ASEAN Pharmaceutical Harmonization through collaboration – Past, Present & Future
Ms. Dato’ Eisah Abdul RAHMAN, Senior Director of Pharmaceutical Service, Ministry of Health Malaysia |
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11.45 - 12.30 am
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Modernizing Regulatory Science: New Tools in Determining Risk in a products lifecycle
Ms. Justina MOLZON, Former Associate Director for International Programs, Center for Drug Evaluation and Research, U.S. FDA |
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12.30 - 01.30 pm
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Lunch
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01.30 - 02.30 pm
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Evolution of the Drug Research and Development Regulatory Process
Ms. Justina MOLZON, Former Associate Director for International Programs, Center for Drug Evaluation and Research, U.S. FDA |
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02.30 - 02.45 pm
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Coffee Break
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02.45 - 04.00 pm
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European Pharmaceutical Marketing Authorisation Procedures: EU Example
Dr. Aomesh BHATT, European Area Regulatory and Medical affairs Director, RB Healthcare UK |
Day 2: Wednesday August 26, 2015
Theme: Progression in pre-approval phase among ASEAN member countries
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09.00 - 09.45 am
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Marketing Authorization Procedure of Pharmaceutical products in Thailand
Ms. Pattawadee ORKOONSAWAT, Thai Food and Drug Administration |
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09.45 - 10.30 am
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ASEAN Common Technical Dossier (ACTD) Dossier Requirement
Mdm. Rosilawati AHMAD, Head of the Regulatory Coordination Section, National Pharmaceutical Control Bureau |
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10.30 - 10.45 am
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Coffee Break
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10.45 - 11.30 am
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Challenges in regulatory approval of Biopharmaceutical in ASEAN
Ms. Teeranart JIVAPAISARNPONG, Director of Institute of Biological Products, Department of Medical Science |
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11.30 - 12.15 am
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APAC - Good Submission Practice: Principle and implementation
Mr. Isao SASAKI, Director Asian Regulatory Group, Astellas Pharma Inc. |
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12.15 - 01.15 pm
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Lunch
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01.15 - 02.45 pm
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Panel Discussion: Challenges and Opportunities in e-Submission
Mr. Vinit USAVAKIDVIREE, Advisory in Standard of Health Products (Acting), Thai FDA, Mr. Teerapong CHEEPCHOL, Deputy Managing Director, Factorytalk Co., Ltd, Dr. Noppadon ADJIMATERA, South East Asia (SEA) Regulatory & Medical Affairs Director,Reckitt Benckiser, Thailand Kanokwon Prasitporn, Thailand Regulatory Affairs Director, Siam Bheasach Co.,Ltd. |
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02.45 - 03.00 pm
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Coffee Break
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03.00 - 04.30 pm
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Progress in ASEAN pharmaceutical harmonization regulation & technical requirement: Quality, Safety and Efficacy
Ms. Ega FEBRINA, Head of Sub directorate New Drug Evaluation, Indonesia Food and Drug Administration, Ms. Regina Rosario S.OBLIGACION, Philippines Food and Drug Administration, Ms. Parichard CHIRACHANAKUL, Pharmacist Professional Level, Pre-marketing Division, Thai Food and Drug Administration |
Day 3: Thursday August 27, 2015
Theme: Post-approval activities, quality system and pharmacovigilance
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09.00 - 10.00 am
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Overview of post-approval regulatory requirement
Madam Sameerah Shaik Abdul RAHMAN, Deputy Director, Head of Centre for Post Registration of Products, National Pharmaceutical Control Bureau, Malaysia |
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10.00 - 10.45 am
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Pharmacovigilance as tool to monitor drug safety
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10.45 - 11.00 am
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Coffee Break
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11.00 - 11.45 am
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Benefit risk management in practice
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11.45 - 01.00 pm
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Lunch
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02.30 - 02.45 pm
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Coffee Break
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01.00 - 01.45 pm
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Pharmaceutical Manufacturing and Quality Systems
Ms. Ellen, Ying-Hua CHEN, Section Chief/GMP Inspector, Taiwan FDA |
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01.45 - 02.00 pm
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Closing ceremony
Dr. Rungpetch SAKULBUMRUNGSIL, Dean of Faculty of Pharmaceutical Sciences |
| agenda_23_august.pdf |
@ 24 August 2015