BioequivalenceTesting – 2012

International Symposium on

August 21 – 22, 2012

Bangkok, Thailand

Ambassador Hotel Bangkok171 Sukhumvit Soi 11, Klongtoey District

Bangkok 10110 Thailand

Registration Form

Name (Thai) .................………………………………...ใบประกอบวิชาชีพ เลขที่ ภ. ..............………(ถ้ามี)Name (English) .............................................…………Address .........................………………………………………………………................................……………………………………………………………………………..…………………………………….......................................Tel ………………………............................................... Email……………………………………………..............

Status: Academic Industry government service student Non Thai resident

Amount Paid ……………………………………………..

Receipt issued to: (if different from above registrant) ……………………………………………………………..……………………………………………………………..

Registration FeeThai resident 3500 Thai BahtNon Thai resident 200 USDStudent* 1500 Thai Baht* Endorsement of a faculty staff is required

Payment ProcedureTransfer the money to Krungthai Bank, Sriayudhya Road, Bangkok, Account Name : "Academic Fund of Dr. Sompol Prakongpan" Saving Account Number : 013-0-20736-5 Bank Account : KRUNGTHAI BANK PUBLIC CO., LTD. (Sri-Ayuddhaya Road Branch)Bank Address : 513, Sri Ayuddhaya Rd., Rachathevee, Bangkok 10400 THAILANDSwift Code : KRTHTHBKRegistration ProcedurePlease send the completed registration form and a copy of payment document to: The Pharmaceutical Association of Thailand under Royal Patronage 40 Sukhumvit 38 Klongtoey District Bangkok 10110 Thailand Tel : +662 3916243; +6627121627 ext 13 Fax : +662 3901987; +6627121627 ext 14 Email : pharmathai2000@yahoo.com

Registration Deadline Registration must be done by 14 August 2012

International Pharmaceutical Federation (FIP)American Association of Pharmaceutical Scientists (AAPS)Thai Food and Drug Administration (TFDA)The Pharmaceutical Association of Thailand under Royal Patronage (PAT)Thai Pharmaceutical Manufacturers Association (TPMA)Thai Industrial Pharmacist Association (TIPA)Regulatory Affairs Pharmacy Association (Thailand)Faculty of Pharmaceutical Sciences, Burapha University

Bioequivalence is the key to ensuring safe and effective generic medicines. As the generic pharmaceutical industry continues to grow worldwide as well as in the ASEAN Economic Community (AEC), international regulatory compliance is required. In recent years, there have been significant changes in bioequivalence testing. This symposium aimed to update current practice and evaluation of bioequivalence study based on newer requirements and expectation of the regulating agency.

Tuesday August 21, 2012Opening Session0840-0850 Welcome Address Professor Sompol Prakongpan Chairman, Organizing Committee0850-0900 Opening Remark Teera Chakajnarodom President, The Pharmaceutical Association of Thailand under Royal Patronage

Session 1: Overview and pharmacokinetic BE studies0900-0945 The why and how of bioequivalence testing. (an overview of why and when BE must be assessed and if so, with which methods BE can be assessed) Jennifer Dressman0945-1030 Standard design of pharmacokinetic BE studies Anita Nair1030-1045 Break1045-1130 Special cases: what to do about NTIs, metabolites, drugs that are to be administered with food, those with long half-lives etc. Sandra Klein1130-1215 What dissolution tests need to be performed in conjunction with pharmacokinetic BE studies? Vinod Shah 1215-1315 Lunch Break

Session 2: Alternatives to pharmacokinetic BE testing. I. The BCS-based Biowaiver1315-1400 The BCS-based Biowaiver - what is the BCS and how to classify the drug? Vinod Shah1400-1445 BCS-based biowaivers - an overview of which drug/product combinations are eligible and how to determine whether a particular drug/product can be approved by this procedure Jennifer Dressman1445-1500 Break 1500-1545 BCS-based biowaivers - What dissolution tests are needed and how the results should be evaluated Sandra Klein1545-1630 Biowaiver Monographs - some case examples Anita Nair

Wednesday August 22, 2012Session 3: Further alternatives to pharmacokinetic BE testing.0900-0945 Biowaivers for lower dosage strengths Vinod Shah0945-1030 IVIVC - classical approach with deconvolution Sandra Klein1030-1100 Break1100-1200 IVIVC - alternative methods using PBPK modeling & Role of IVIVC in Quality by Design Jennifer Dressman1200-1315 Lunch Break

Session 4: Special considerations for Thailand and Panel Discussion1315-1345 BE testing in Thailand – Regulatory, deficiency of BE Study Tharnkamol Chanprapaph 1345-1415 Presentation of case examples in Thailand Ariya Khunvichai 1415-1430 Break1430-1630 Panel Discussion with all speakers Sompol Prakongpan, Moderator