Agenda

All times displayed for Asia/Bangkok timezone.

Global Force on Pharmaceutical Serialization Track & Traceability
09:30 - 16:30 Meeting Room 4
Conference

Sponsored by:

Language: English
Admission: THB 749.-/Person (inc. VAT)
Registration Link: HERE 
CPEs: 5.25 credits

10:00-11:00 Introduction to Serialization Track & Traceability, Global Procurement on Pharmaceutical Serialization Track & Traceability
Speaker: Mr. Shawn Chen, GS1 Thailand)

11:00-12:00 GS1 Standard: What is it? What are these terms GS1, GTIN, SGTIN, EPCIS, Data Matrix barcode? How to develop and implement global standards for patient safety and supply chain efficiencies?
Speaker: Mr. Shawn Chen, GS1 Thailand)

12:00-13:00 Lunch break

13:00-14:30 Serialization Track & Traceability System for Pharmaceutical Supply Chain
Speaker: BOSCH

14:30-14:45 Afternoon break

14:45-16:30 Challenges on Implementing Serialization Track & Traceability in Pharmaceutical Industry
Speaker: BOSCH

Note: The training course will be in English.

For more information please contact:
Ms.Uangfa Vechvimol 
Tel. 66 2 863-5106, 2 866-1803
Fax : 66 2 863-5108
E-mail : [email protected]
Website: www.tpma.or.th

การอบรม การจัดเตรียมเอกสารทะเบียนตำรับยาสามัญแบบ ACTD (for beginners)
09:30 - 16:30 บอลรูม
Conference

Sponsored by:

Language: Thai
Admission: THB 749 บาท/คน
Registration Link: https://docs.google.com/forms/d/1Ycg2PtRGkSN9X1YhLH6tnE4KRJdLDKBYc4sxqmo...

10:00 – 11:00 AM. How to Successfully Submit Drug Dossier Applications for the Registration
Dr. Suchart Chongprasert Director of Bureau of Drug Control

11:00 AM.– 12:00 PM. Part I : Administrative Data and Product Information
Ms. Kulwadee Sawaspaiboontawee
12:00 – 13:00 PM. Lunch
13:00 – 13:45 PM. Part II : Quality Document (Drug Substance)
Ms. Kulwadee Sawaspaiboontawee
13:45 – 14:45 PM. Part II : Quality Document (Drug Product)
Ms. Supatra Phongsri
14:45 – 15:00 PM. Coffee Break
15:00 – 15:45 PM. Issues in Dossier Screening Process
Ms. Kulwadee Sawaspaiboontawee
15:45 – 16:30 PM. Q&A
Ms. Supatra Phongsri

หมายเหตุ  :  โปรดอ่านคำอธิบายหลักเกณฑ์การขึ้นทะเบียนตำรับยาสามัญก่อนเข้าร่วมการอบรม
สอบถามข้อมูลเพิ่มเติมติดต่อ : คุณเอื้องฟ้า เวชวิมล  โทร : 66 2 863-5106, 2 866-1803
แฟกซ์ : 66 2 863-5108  อีเมล : [email protected]  เว็บไซต์ : www.tpma.or.th 

*Organizer reserves the right to amend program without prior notice*

Moving towards Pharma 4.0
09:30 - 16:30 Lotus
Conference

Sponsored by:

Language: English
Admission: THB 749.-/Person (inc. VAT)
Registration Link: HERE

10:00-11:00 From Industry 4.0 to Pharma 4.0
Speakers: Mr. David Holt (Factorytalk), Ms. Manuh Pitasari (Factorytalk)

11:00-12:00 Pharma 4.0 Technology Enablers
Speakers: Mr. David Holt (Factorytalk), Ms. Manuh Pitasari (Factorytalk)

12:00-13:00 Lunch break

13:00-14:30 Path to 4.0:  Big vs ASEAN Pharma | MES in Pharma 4.0 | Practical steps for ASEAN Pharma
Speakers: Mr. David Holt (Factorytalk), Mr. Orchun Thakral (Werum IT Solutions Ltd., Thailand)

14:30-14:45 Afternoon break

14:45-16:30 Cybersecurity for Industry 4.0: Management and Regulatory Concerns | Manufacturing and Design
Speaker: Mr. Jason Young, (Silver Bullet Security Services Co., Ltd.)

Note: The training course will be in English

For more information please contact:
Ms. Uangfa Vechvimol
Tel. 66 2 863-5106, 2 866-1803
Fax : 66 2 863-5108
E-mail : [email protected]
website: www.tpma.or.th 

ASEAN Regulatory Framework
10:00 - 12:30 Meeting Room 3
Conference

Language: English
Admission: Free of charge (Reserved the right for registered visitors and on first come first serve basis for seating and Food and beverage)

10.00 – 10.40 “Vietnam Pharma Industry : Actual Status and Perspective for 30 decade”
by Dr.Le Van Truyen, Former Deputy Minister, Vietnam Ministry of Health

10.45 – 11.20 “Vietnam Regulatory Framework”
by Ms. Ngo Thi Huong Minh, Deputy Manager, Department of Drug Administration, Vietnam Ministry of Health

11.20 - 12.00 TBC

For more information please contact: Mr. Jaturong Molsuwan Tel. 020360500 #753 or E-mail: [email protected]

Data Integrity assurance as a key factor for surviving corporate audits and regulatory
11:00 - 11:30 Meeting Room 1
Exhibitor Seminar
Vice President Business Development, Partner (PQE Group)
Pharma Quality Europe S.R.L

Sponsored by:

Language: English
Admission: Free of charge

Data integrity issues were the most striking findings in the last years. European and US investigators found data manipulation, cover-ups with faked test results, uneven paper trails, destroyed or misplaced records, backdated production reports. Data integrity lapses have become so widespread globally, that even the World Health Organization stepped in last year to issue guidance to bridge the gaps between the principles of good data and record management and actual practices.

Skin and actives –Inside&Outside
11:45 - 12:15 Meeting Room 1
Exhibitor Seminar
Market Manager, Nutrition Actives (SEPPIC - Air Liquide Healthcare Specialty Ingredients)
Onimax Co., Ltd.
Market Manager, Dermopharmacy (SEPPIC - Air Liquide Healthcare Specialty Ingredients)
Onimax Co., Ltd.

Sponsored by:

Language: English
Admission: Free of charge

Natural actives for health and beauty of the skin- a complementary approach with in & out strategy. Summary: Combining our expertise in Beauty and Health,There are the new secrets for a beautiful and healthy skin. Come and discover CERAMOSIDESTM, an outstanding nutritional ingredient with clinically proven efficacy. It is the ultimate moisturizer for smooth and youthful skin, allowing to replenish the wrinkles and give a healthy glow. Innovate with TECA PharmaTM, a pharmaceutical extract of Gotu Kola used for 60 years in wound healing applications. Discover where its optimal efficacy & safety profiles can be key assets for extending over new therapeutic areas.

Constantia Digital Services & Innovative packaging solutions for pharma industry
13:15 - 13:45 Meeting Room 1
Exhibitor Seminar
Account Manager
Constantia Flexibles International GmbH
Technical Key Account Manager
Constantia Flexibles International GmbH

Sponsored by:

Language: English
Admission: Free of charge

Make sure you check what are the latest Constantia innovative packaging solutions for the pharma industry and discover the advantages of Constantia Digital Services! Not only can we provide perfect packaging solutions for your products, we are also ready for the digital era. The combination of CONSTANTIA Interactive and CONSTANTIA Digital will change the way pharma companies interact with patients by enabling personalized medicine and improving patient adherence, convenience and safety.

สถานการณ์การดื้อยา การจัดการ และการปรับตัวของภาคการวิจัยและภาคการผลิต Antimicrobial Resistance Situation
13:30 - 16:00 Meeting Room 3
Conference

Sponsored by:

Language: Thai
Admission: ฟรี

13:30-13.40 น. ลงทะเบียน และรับประทานอาหารว่าง

13:40-13.45 น. กล่าวเปิดงาน โดย คุณรุ้งเพชร ชิตานุวัตร์
ผู้อํานวยการกลุ่มโครงการ - ภูมิภาคอาเซียน บริษัท ยูบีเอ็ม เอเชีย (ประเทศไทย) จํากัด

13:45-14.14 น. สถานการณ์การดื้อยาและการจัดการของประเทศในภูมิภาคอาเซียนและประเทศไทย
โดย คุณวันทนา ปวีณกิตติพร - สถาบันวิจัยวิทยาศาสตร์สาธารณสุข

14:15-14.45 น. เทคโนโลยีล่าสุดในการตรวจหาเชื้อดื้อยา
โดย คุณนักสิทธิ์ มณีรัตน์ ผู้เชี่ยวชาญ เทอร์โมฟิชเชอร์ ไซเอ็นทิฟิค

14:45-15.30 น. สถานการณ์การค้นพบยาฆ่าเชื้อใหม่ๆ
โดย รศ.ดร.ภญ. วิไล เทียนรุ่งโรจน์ หนุนภักดี

15:45 น. ถาม-ตอบ

16.00 น. ปิดงานสัมมนา

สอบถามข้อมูลเพิ่มเติมติดต่อ: คุณจตุรงค์ มลสุวรรณ โทร: 020360500 #753
หรือ อีเมล: [email protected]

*Organizer reserves the right to amend program without prior notice*

How to successfully build and launch your generic drugs portfolio?
14:00 - 14:30 Meeting Room 1
Exhibitor Seminar
Solutions Consultant, Southeast Asia
Clarivate Analytics

Sponsored by:

Language: English
Admission: Free of charge

With more and more players getting into the generic drugs space, it is getting increasingly difficult to put together and market a unique portfolio. You will learn the different set of parameters and angles that can be exploited to create a strategy for generating an exclusive portfolio. Find out on how to spot opportunities to enter new disease areas, pinpoint the markets with significant target patient population, establish the right partnerships, and monitor the competitive landscape of API manufacturers and finished dose companies.

Rising Era of Potent Drug Manufacturing in SEA
14:45 - 15:15 Meeting Room 1
Exhibitor Seminar
CEO and President
Affygility Solutions

Sponsored by:

Language: English
Admission: Free of charge

Introductory Insight on EHS, Regulatory and Handling of High Potent (Category 3 and above; eg: Oncology) Drugs

Key Objectives:
• Introduction, current trends, challenges & opportunities in HPAPI development & manufacturing
• Regulatory view and GMP landscape on manufacturing of highly potent drugs
• Ten common occupational health and safety audit findings from High Potency API facilities in the developing world
• Occupational safety for handling of highly potent drug products
• Real-life learnings, experience and changing regulatory environment – future trends
• Establishing OELs/ADEs for potent & highly potent compounds
• Affygility solutions: Our story

SEA Pharmaceutical Industry: Business models and business plan for the way forward
15:30 - 16:15 Meeting Room 4
Exhibitor Seminar

Sponsored by:

Language: English
Admission: Free of charge

This interactive strategic session addresses the following:
1. Global and SEA Regional Pharmaceutical Landscape
2. SEA Regional Business Ecosystem- Macroanalysis
3. Initial and Sustainable Business Models
4. Business Plan
5. Action Plan
6. SEA Pharmaceutical Industry Value Chain Mapping and its benefits
7. Case Studies

Automatic methods to release defect free parenteral containers
15:30 - 16:00 Meeting Room 1
Exhibitor Seminar
Product Specialist
Bonfiglioli Engineering s.r.l.

Sponsored by:

Language: English
Admission: Free of charge

How technology meets regulatory expectations to aim for the highest quality standards leading to safer products, a journey into the most recent developments in inspections systems. Not only visual inspection but mostly container closure integrity testing executed by means of USP<1207> approved deterministic methods such as Vacuum and Pressure Decay as well as laser-base Headspace Gas Analysis. All non-destructive techniques allowing both IPC and 100% application also combining more than one technology in the same machine. From theory to practice up to validation methods and analysis of real case studies.