ISPE Indonesia

Tentative Agenda, ISPE Indonesia: 2018 Annual Conference

ISPE Indonesia akan menyelenggarakan Annual Conference 2018 pada tanggal 8-9 May 2018 di Hotel Holiday Inn, Kemayoran, Jakarta.

Dengan tema ‘BEYOND COMPLIANCE – Protecting Patients, Support Innovation’. Topik yang juga akan dibahas tentang Serialization- yang kini sedang viral, dimana BPOM berencana menerapkan di Indonesia dalam waktu dekat, akan dibahas dari berbagai sudut pandang.

Selain itu, akan dibahas mengenai pengetahuan tentang industri Farmasi, baik yang saat ini sedang menjadi tren atau arah masa depan industri Farmasi di masa datang.

Berikut ini Tentative Agenda:
Day 1 – Tuesday, May 8, 2018
Plenary
09.00 – 09.15 : Opening (ISPE Indonesia)
09.15 – 09.55 : Keynote 1 and Open Conference (Head of Indonesia NADFC)
09.55 -10.40 : Keynote 2 : Future Milestone of PIC/S (Boon Meow Hoe- PIC/S Chair)
10.40 – 11.20 : Coffee Break
11.20 – 12.00 : Keynote 3 : Sustainability of Pharmaceutical manufacturing (Ferry Soetikno- ISPE Advisory Board)
12.00 – 12.45 : Keynote 4 : Disruptive Innovation in Pharma Industry – Beyond Medicine (Norikazu Eiki , USA)
12.45 – 13.15 : Panel Discussion – Herny Prasetya (All Keynote Speakers)
13.15 – 14.00 : Lunch

Breakout Session
Track 1 : Culture and Behaviour
14.00 – 14.45 : Redefining the “C” in CGMP – Creating ,Implementing and Sustaining Culture of Compliance (TBD)
14.45 – 15.30 : How to Build and Foster a Quality Culture (Frans Mardi Hartanto-ITB)
15.30- 16.15 : Break
16.15 -17.00 : Working as A Team (Frans Mardi Hartanto-ITB)

Track 2: Serialization
14.00 -14.45 : Enterprise to Line: IT Solutions for Serialization (David Margetts – WERRUM,Germany)
14.45 – 15.30 : Track and Trace (Giovanni Lanzilli- Antares,Italy)
15.30 – 16.15 :Break
16.15 – 17.00 : Strategy in Implementing Serialization in Emerging Economy Countries (Ian Haynes – Excellis,UK)

Day 2- Wednesday, May 9 ,2018
Track 3 : Regulatory
08.30 – 09.15 : Harmonization (Vee Revithi – ISPE)
09.15 – 10.00 : Industry Maturity (NADFC-Indonesia)
10.00 – 10.45 : Break
10.45 -11.30 : Important Consideration to WHO PQ; Critical and Major Observation During PQ Audits (Vimal Sachdeva- WHO)
11.30 – 12.15 :Life After PIC’S Membership : Challenges for Authority and Industry (Suchart Chongprasert- Thai FDA)
12.15 – 12.45 :Panel Discussion – Bob Tribe (All)
12.45 – 14.00 : Lunch

Track 4 : Manufacturing

08.30 – 09.15 : Factory of The Future (TBD)
09.15 – 10.00 : Regulatory trends in Aseptic Processing for Biopharmaceutical Industries (Merck)
10.00 – 10.45 : Break
10.45 – 11.30 : Automation in Packaging System to Support Serialization (Klaus Braig – Uhlmann)
11.30 – 12.15 : Risk Based Qualification (Pierre Winnepenninckx.- ISPE)
12.15 -13.00 : New Technology on Finding Optimum Barrier Films for Primary Packaging (Sunil Satav-Billcare)
13.00- 14.00 : Lunch

Track 5 : Quality Beyond Compliance

14.00 – 14.45 : EDQM Certificate of Suitability (Cristian SAMPAOLESI- EDQM)
14.45 – 15.30 : Process Analytical Technology (Viturs Analytica)
15.30 – 16.00 : Break
16.00 – 16.45 : Quality 4.0 (Manuh Pitasari – Factory Talk)
16.45 – 17.30 :Beyond Stability Storage Roland Krebs – Nagano
17.30 : Closing

Track 6 : Product and Process Development

14.00 – 14.45 : Exipient-Evolutions of Exipients GMP and Vendor’s Audit (Merck)
14.45 – 15.30 : New Standards Define Single-Use Materials Qualification (Sade Mokuolu – WATSON)
15.30 – 16.00 : Break
16.00 – 16.45 : The importance of QbD in Designing Process Performance Monitoring System during Commercial Manufacturing
(Virtus)
16.45 – 17.30 : Building Management System and Environmental Monitoring Systems in Regulated Environment (Maurice Parlane-ISPE)
17.30 : Closing.

Pendaftaran:
Untuk Registrasi online dapat diakses melalui link http://pharma-pro.co.id/ispe-annconf/Registration_Form.php

Informasi lebih lanjut: ISPE INDONESIA CONFERENCE SECRETARIAT: Ms. Sari Rosaliana, Komplek Perkantoran Duta Merlin Blok C/35-36, Jl. Gajah Mada 3-5, Jakarta 10130, Phone: +6221-63869502. Fax: +6221-63869502/05, Mobile: +6857.1113.2772 (Ms. Sari), Email: ispeind.annconf@pharma-pro.com atau sari.rosalina@pharma-pro.com

ISPE Indonesia
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