Tentative Agenda, ISPE Indonesia, 2018 Annual Conference

Tanggal Posting : Rabu, 11 April 2018
Dibaca : 179 Kali

ISPE Indonesia akan menyelenggarakan Annual Conference 2018 pada 8-9 Mei 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-Day-2- Wednesday, May 9, 2018

Track 3 : Regulatory

  • 08.30-09.15 : Harmonization (Vee Revithi - ISPE)
  • 09.15-10.00 : Industry Maturty (NADFC-Indonesia)
  • 10.00-10.45 : Break
  • 10.45-11.30 : Important Considerantion to WHO PQ; Critical and Major Observation During PQ Audits(Vimal Sachdeva-WHO)
  • 11.30-12.15: Panel Discussion - Bob Trible (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 ofSuitability (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 Nagono)
  • 17.30: Closing

Track 6: Product and Process Development

  • 14.00 - 14.45 : Exipient-Evolutions of Exipients GMP and Vendors 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: 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, Jl. Gajah Mada 3-5, Jakarta 10130, Phone: +6221-63839502. Fax: +6221-63869502/05, Mobile: +6857.1113.2772 (Ms. Sari), Email: ispeind.annconf@pharma-pro.com atau sari.rosalina@pharma-pro.com

Related Link
Contact Us

ISPE Indonesia Affiliate Secretariat

Website : www.ispeindonesia.org

alamat Titan Centre
Jln. Boulevard Bintaro, Block B7/B1 No.5 Bintaro Jaya, Sektor 7
Tangerang 15244, Indonesia
telp +62 21 745 2673
fax +62 21 745 2614
email info@ispeindonesia.org

ISPE Headquarters

Website : www.ispe.org

alamat 600 N. Westshore Blvd., Suite 900
Tampa, Florida 33609 USA
telp +1-813-960-2105
fax +1-813-264-2816
email ask@ispe.org
Visitor

Flag Counter