The ISPE Indonesia Annual Conference: 24th-25th June 2019

Tanggal Posting : Jumat, 15 Maret 2019
Dibaca : 431 Kali

Preliminary Information. The ISPE Indonesia Annual Conference is a prestigious event for pharmaceutical industri and their stakeholders, the theme for 2019 event is Sustainable Compliance Driving Business Growth, which include a plenary session and 6 breakout track.

PROGRAM. PLENARY: Keynote Speeches and Panel discussions

  • Track 1: Leadership and Quality Culture
  • Track 2: Driving from Conventional to New Technology
  • Track 3: Biosimilar / Biotechnology
  • Track 4: Holistic Control Strategy
  • Track 5: Manufacturing & Quality Data Integrity
  • Track 6: PQS Driven to Sustainable Compliance

Important Program:
Conference: Monday & Tuesday, 24th - 25th June, 2019
Exhibition: Monday & Tuesday, 24th - 25th June, 2019

Seminar Fee:

  • ISPE Indonesia Affiliate Member*: IDR 2.700.000,-
  • *10% Discount for minimum 6 participants from same company
  • Non ISPE Indonesia Affiliate Member: IDR 3.700.000,-
  • Lecturer: IDR 1.400.000,-
  • Regulator: IDR 1.400.000,-
  • Student: IDR 500.000,- / Day
    Cancelation after May 1st, 2019, 50% refund
    Cancelation after June 3rd, 2019, no refund

Deadline For Registration: Monday, 17 June, 2019

Please kindly registered following link below: http://pharma-pro.co.id/ispe.annconference2019/

If you have any questions, please do not hesitate to contact us via:
Email: ispeind.annconf@pharma-pro.com
Or call at: +6285711132772 (WA) & 081212488875 (Ms. Sari).

Tentative Agenda. Day 1 - Monday, 24 June 2019

  • 08.00 - 08.45: Registration. Plenary (Angsana 1)
  • 08.45 - 09.00: Opening (ISPE Indonesia)
  • 09.00 - 09.30: Keynote Speech - Dirjen Kimia, Farmasi dan Tekstil Kementerian Perindustrian Republik Indonesia (Ir. Achmad Sigit Dwiwahjono, M.PP)
  • 09.30 - 10.15: Exhibition Opening and Break
  • 10.15 - 11.00: Indonesia 4.0 - Direktur Industri Kimia Hilir dan Farmasi Kementerian Perindustrian Republik Indonesia (Dr. Ir. Taufiek Bawazier, M.Si)
  • 11.00 - 12.00: Industry Leaders Readiness for the Coming Industry 4.0 (Rhenald A. Khasali)
  • 12.00 - 13.00: Lunch
  • 13.00 - 13.45: Driving Quality Culture through Leadership (Ferry Soetikno- ISPE Indonesia Advisory Board)
  • 13.45 - 14.30: Quality is Free (Frans Mardi Hartanto)
  • 14.30 - 14.45: Panel Discussion: Herny Prasetya
  • 14.45 - 15.15: Break
  • 15.15 - 15.45: Current Trends in the Field of Drug Circulation in the Russian Federation - Russian Regulator (Vladimir Orlov)
  • 15.45 - 16.15: Regulation to Export Product to Australia (Bob Tribe)
  • 16.15- 16.45: Regulation in Exporting Product to Malaysia - National Pharmaceutical Regulatory Agency of Malaysia (Mohammad Lukmani)
  • 16.45 -17.00: Regulators and Retno Tyas Utami (Regulators + Retno Tyas Utami)
  • 17. 00: Closing

Tentative Agenda. Day 2- Tuesday, 25 June 2019

Track 1 :Leadership and Quality Culture

  • 08.30 - 09.15: Executives Roles on shaping Quality Culture (Benni Sutisna -Dexa Group)
  • 09.15 - 10.00: Journey to Sustainable Compliance - Talk show (Bayer & Biofarma)
  • 10. 00 - 10.45: Become Visionary Leader (Frans Mardi Hartanto)
  • 10.45 - 11 30: Break

Track 3 : Quality Data Integrity

  • 11.30 - 12.15: E-QMS / PQS : Agile Approach to Product Realization and Lifecycle Management (Factory Talk)
  • 12.15 - 13.00: Controlling Chromatographic Integration to Ensure Data Integrity (TBD)
  • 13.00 - 14.00: Lunch

Track 5 :Manufacturing Data Integrity

  • 14.00 - 14.45: Data security (Solinda-Oracle)
  • 14.45 - 15.30: Data integrity of Manufacturing Data (TBD)
  • 15.30 - 16.00: Break
  • 16.00 - 16.45: Continuous Bioprocessing for mAbs and Proteins : Upstream to Downstream, Formulation & Filling (Esco)
  • 16.45 - 17.30: Biosimilar Regulation in Indonesia (BPOM (RTU)
  • 17.30: Closing

Tentative Agenda. Day 2- Tuesday, 25 June 2019

Track 2 : Driving From Conventional to New Technology

  • 08.30 - 09.30: Risk Management in Storage Stability Testing, a Risk and Science Based Approach (Roland Kerbs - Nagano)
  • 09.30 - 10. 15: From Industry 4.0 to Pharma 4.0 : The Holistic Control Strategy (Werrum)
  • 10. 15 - 11.00: Implementing Transmission Raman for Fast Content Uniformity Testing (TBD)
  • 11.00 - 11.30: Break

Track 4 : Control Strategy

  • 11.30 - 12.15: A New Concept for Safer Medicines : Serialization and Aggregation (Bart Vansteenkiste- Domino)
  • 12.15 - 13.00: TBD (Itamas)
  • 13.00 - 14.00: Lunch

Track 6 : Sustainable Compliance

  • 14.00 - 14.45: A Practical Approach to Cleaning Validation- Guidelines ,Toxicological Limits, Sampling (Steris)
  • 14.45 - 15.30: Practical Implementation of The Lifecycle Approach to Process Validation (Maurice Parlane)
  • 15.30 - 16.00: Break
  • 16.00 - 16.45: Applying Continuous and Ongoing Process Verification during Lifecycle: from Control Strategy to Product Quality Review (Maurice Parlane)
    16.45 - 17.30: Business perspectives -How Quality drive the Business (Krestijanto Pandji)
    17.30: Closing.

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
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