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Provisional Program

Day 1: Tuesday August 25, 2015

08.00 - 09.00 am
Registration
09.00 - 09.20 am

Opening remarks from Conference Chairpersons 
Dr. Rungpetch SAKULBUMRUNGSIL, Dean of Faculty of Pharmaceutical Sciences,
Professor Pirom KAMOLRATANAKUL, MD., President of Chulalongkorn University,
Dr. Boonchai SOMBOONSUK, Secretary-General at Food and Drug Administration,
Professor Dr.Wanlop SURAKAMPONTORN, National Science Technology and Innovation Policy Office

09.20 - 10.00 am
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

10.00 - 10.15 am
Coffee Break
10.15 - 11.00 am
Introduction to Pharmaceutical Medicine           
Dr. Yil-Seob LEE, Director, Medical & Regulatory Affairs, GSK Korea
11.00 - 11.45 am
Realisation of ASEAN Pharmaceutical Harmonization through collaboration – Past, Present & Future
Ms. Dato’ Eisah Abdul RAHMAN, Senior Director of Pharmaceutical Service, Ministry of Health Malaysia
11.45 - 12.30 am
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
12.30 - 01.30 pm
Lunch
01.30 - 02.30 pm
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

02.30 - 02.45 pm
Coffee Break
02.45 - 04.00 pm
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

09.00 - 09.45 am
Marketing Authorization Procedure of Pharmaceutical products in Thailand
Ms. Pattawadee ORKOONSAWAT, Thai Food and Drug Administration

09.45 - 10.30 am
ASEAN Common Technical Dossier (ACTD) Dossier Requirement
Mdm. Rosilawati AHMAD, Head of the Regulatory Coordination Section, National Pharmaceutical Control Bureau
10.30 - 10.45 am
Coffee Break
10.45 - 11.30 am
Challenges in regulatory approval of Biopharmaceutical in ASEAN
Ms. Teeranart JIVAPAISARNPONG, Director of Institute of Biological Products, Department of Medical Science

11.30 - 12.15 am
APAC - Good Submission Practice: Principle and implementation           
Mr. Isao SASAKI, Director Asian Regulatory Group, Astellas Pharma Inc.
12.15 - 01.15 pm
Lunch
01.15 - 02.45 pm
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.
02.45 - 03.00 pm
Coffee Break
03.00 - 04.30 pm
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 

09.00 - 10.00 am
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

10.00 - 10.45 am
Pharmacovigilance as tool to monitor drug safety
  • Implementation in the market place: Japan example (45 minutes)
    Dr. Takashi MISU, Office of Safety II, Pharmaceuticals and Medical Devices Agency (PMDA)
10.45 - 11.00 am
Coffee Break
11.00 - 11.45 am
Benefit risk management in practice
  • Benefit-risk framework and Risk management planning: Regulatory Requirement & Future Perspective (45 minutes)
    Dr. Takashi MISU, Office of Safety II, Pharmaceuticals and Medical Devices Agency (PMDA)
11.45 - 01.00 pm
Lunch
02.30 - 02.45 pm
Coffee Break
01.00 - 01.45 pm
Pharmaceutical Manufacturing and Quality Systems
Ms. Ellen, Ying-Hua CHEN, Section Chief/GMP Inspector, Taiwan FDA
01.45 - 02.00 pm
Closing ceremony
Dr. Rungpetch SAKULBUMRUNGSIL, Dean of Faculty of Pharmaceutical Sciences

agenda_23_august.pdf
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@ 24 August 2015
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