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  • CONFERENCE AND EXHIBITION Technology Innovations, Improving Healthcare

    “The ISPE conference is an excellent way to get energised to deliver value to my organization. I feel confident in the implementation of concepts I learnt here” Catherine Le Denmat, Associate Engineer, MSD

    Organised By

    21 - 23 AUGUST 2019 I SUNTEC SINGAPORE

    Keynotes Melissa Guan Head of Healthcare Economic Development Board, Singapore

    Alexander Zach Head of Market Access & Policy, Biocon Biologics Limited, India

    www.ispesingapore.org

    1000+ PARTICIPANTS

    65+ SPEAKERS

    25+ COUNTRIES

    6 TRACKS

    19 YEARS IN SINGAPORE

    NEW IN 2019!

    CLEANING AND VALIDATION, AND TECH TRANSFER

    QUALITY AND COMPLIANCE

    MANUFACTURING FOR CELL AND GENE THERAPY

    ASEPTIC OPERATIONS

    LEAN AND OPERATIONAL EXCELLENCE

    PROJECT MANAGEMENT / ENVIRONMENT,

    HEALTH AND SAFETY

    PHARMA 4.0, DATA INTEGRITY

    & GAMP

  • CONFERENCE AND EXHIBITION

    Technology Innovations, Improving Healthcare

    21 - 23 AUGUST 2019 SUNTEC SINGAPORE

    AGENDA AT A GLANCE:

    CLOSE OF CONFERENCE

    Dr. Toru J Seo Senior Director and APAC Head, Search and Evaluation, Worldwide Business Development, Chief Business Office Pfizer Inc., Japan

    Dr. Gang Wang Vice President, Quality WuXi Biologics, China

    Danee Zainal Head of Manufacturing Alcon, Indonesia

    Christian Cater Head of Operational Excellence Roche, Singapore

    Vladimir Orlov Deputy Head State Institute of Drugs and Good Practices Russia

    Dr. Georg Singewald Head of Global Quality Control, VP Roche, Switzerland

    Jennifer Cheung Head of External Relations Asia Pacific & Global Compliance Business Solutions Genentech, United States

    Hazem Eleskandarani Project Director, Engineering & Property Services Johnson & Johnson, United States

    Farooq Mustafa Chaudhry Associate Director, Quality Operations & Biotech Macter International, Pakistan

    Dr. Sannie Chong Head of Asia Pacific Tech Regulatory Policy - Singapore Technical Operations Roche, Singapore

    Wu Tai Jung Director of Production Technology Division GONGWIN Biopharm, Taiwan

    Simone Hurly Automation Engineer MSD, South Africa

    Steve Oh Institute Professor/Scientist A*STAR, Singapore

    Nirmal Kumar Head of Quality Assurance Novugen Pharma, Malaysia

    Chai Chong Meng Head of Mammalian Manufacturing Lonza Biologics, Singapore

    Anna Koay Director of EHSS Amgen, Singapore

    Dr. Susanna Nagel Quality Site Head Roche, Singapore

    Dr. Syed Abid Hassan Head Regulatory Compliance; Team Leader – Variation Management Committee, Jamjoom Pharmaceuticals Company, Saudi Arabia

    Pierre Winnepenninckx ISPE Singapore Conference Chair, Singapore

    Arnel Cabungcal Assistant Vice President – Manufacturing United Laboratories Inc, Philippines

    Lathalu Krishnamoorthy Quality Assurance Manager ICM Pharma, Singapore

    Kartik Kulbhushan Global Head and Vice President for Operations Strategy and Transformation Dr. Reddy’s Laboratories, India

    Suyamburam Sathasivam Senior General Manager and Head of External Manufacturing Biologics Sun Pharma, India

    Dinar Wahyuni Quality Assurance Executive Strides Pharma, Singapore

    Chandrakant Bhandare Head of Quality Zydus Cadila Myanmar Myanmar

    Jose Luis Narvaez Plant Director United Laboratories, Inc. Vietnam

    Rodel Sibulo Director Pharma Project Operations - Deputy General Director Nanogen Pharmaceutical Biotechnology Joint Stock Company, Vietnam

    Ting-Yuan Tan Manager, Quality Assurance, ASQ Certified Quality Auditor, Tanvex Biopharma Inc., Taiwan

    Wan Mohd Nazeem Wan Asharuddin, Senior EHS Manager Biocon Sdn. Bhd., Malaysia

    Michelle Peake Senior General Manager PT Kalbio Global Medika, Indonesia

    Kelly Keen, Vice President Project Management, Head of PMO, Celonic, Switzerland

    Dr. Steve Oh Institute Scientist / Professor, A*STAR, Singapore

    Dr. Harleen Kaur Senior Research Scientist-I Aurobindo Biologics India

    Paul Tan Head of Manufacturing Excellence, Biologics Takeda Pharmaceuticals, Singapore

    James Weidner Executive Director of Process Development Amgen, Singapore

    Benjamin Sauer Site Technical and Portfolio Lead AstraZeneca, Australia

    Stephen Shi Lean Six Sigma Director Fosun Pharma, China

    Isa Hamzah Asia-Pacific Integrated Manufacturing Excellence Deployment Leader Pfizer, Singapore

    Maurice Parlane, ISPE PV Chapter Lead, Director, ISPE Australasia & Director, Centre for Biopharmaceutical Excellence, Australia

    Teo Szu Hui Site Facility Lead Novartis, Singapore

    Dr. Xiaoping Cao, Vice President and Head of CMC and Supply Chain, Cerecin, Singapore

    www.ispesingapore.org

    MANAGED BY:

    ORGANISED BY:

    EXHIBITORS:

    SPONSORS AND EXHIBITORS

    ASSOCIATE SPONSORS: PARTNER:

    O P T I O N S A N D S O L U T I O N S

    ®

    TRACK SPONSOR:

    21 AUGUST - PRE-CONFERENCE WORKSHOPS

    WOMEN IN PHARMA LUNCH PHARMANITE NETWORKING

    YOUNG PROFESSIONALS NETWORKING

    COMMISSIONING & QUALIFICATION (C&Q), AND NEW GUIDE LINES

    STATISTICS FOR CONTINUED PROCESS VERIFICATION (CPV)

    TRACK A PHARMA 4.0 (AM)

    DATA INTEGRITY AND GAMP (PM)

    TRACK B PROJECT MANAGEMENT (AM) ENVIRONMENT, HEALTH AND

    SAFETY (PM)

    TRACK C ASEPTIC OPERATIONS (AM)

    MANUFACTURING FOR CELL AND GENE THERAPY (PM)

    22 AUGUST - MAIN CONFERENCE DAY 1

    TRACK D QUALITY AND COMPLIANCE

    TRACK E LEAN AND OPERATIONAL EXCELLENCE

    TRACK F CLEANING AND VALIDATION (AM)

    TECH TRANSFER (PM)

    23 AUGUST - MAIN CONFERENCE DAY 2

    STELLAR LINE-UP OF GLOBAL PHARMA MANUFACTURERS AND EXPERTS

    Women in Pharma (WIP)

    Young Professionals

    in Pharma (YP)

    40+ Manufacturers Case Studies

    SUPPORTING ASSOCIATIONS:

    NETWORKING COCKTAIL SPONSOR

    SPONSORS:

  • Technology Innovations, Improving Healthcare

    21 - 23 AUGUST 2019 SUNTEC SINGAPORECONFERENCE AND EXHIBITION

    MAIN CONFERENCE DAY 1: 22 AUGUST 2019, THURSDAY

    10:45 Opening of ISPE Singapore Exhibition and Morning Refreshments

    15:55 Afternoon Refreshments

    09:00 Opening Remarks from ISPE Singapore Joseph Micsko, President, ISPE Singapore Affiliate

    09:10 GOVERNMENT ADDRESS: Harnessing the Full Potential of Pharma 4.0 Melissa Guan, Head, Healthcare, Economic Development Board, Singapore

    09:30 LEADERSHIP KEYNOTE ADDRESS: Driving Innovation for Affordability and Access of Medicines Alexander Zach, Head of Market Access & Policy, Biocon Biologics Limited, India

    10:00 PANEL DISCUSSION: Asia’s Role in Delivering Affordable Quality Healthcare Moderator: Pierre Winnepenninckx, ISPE Singapore Conference Chair, Singapore Panellists: Chai Chong Meng, Head of Mammalian Manufacturing, Lonza Biologics, Singapore Alexander Zach, Head of Market Access & Policy, Biocon Biologics Limited, India Dr. Georg Singewald, Head of Global Quality Control, VP, Roche, Switzerland Dr. Toru J Seo, Senior Director and APAC Head, Search and Evaluation, Worldwide Business Development, Chief Business Office, Pfizer Inc., Japan

    Opening Plenary Sessions

    11:30 Transformation Of The Pharma Value Chain With Industry 4.0 Kartik Kulbhushan, Global Head and Vice President for Operations Strategy and Transformation, Dr. Reddy’s Laboratories, India

    11:30 Project Management Continuous Improvement: Lessons Learned Process Hazem Eleskandarani, Project Director, Engineering & Property Services, Johnson & Johnson, United States

    11:30 Strategies to Keep Parenteral Drug Products Free From Particulate Matter Contamination • Introduction to visible particles’ contamination in parenteral drugs • Adverse effects caused by visible particles • Sources of visible particles • Detection and identification of visible particles • Strategies of effective control of visible particles’ contamination Farooq Mustafa Chaudhry, Associate Director, Quality Operations & Biotech, Macter International Ltd., Pakistan

    12:00 Collaboration and Alliance Through “Open Innovation” Dr. Toru J Seo, Senior Director and APAC Head, Search and Evaluation, Worldwide Business Development, Chief Business Office, Pfizer Inc., Japan

    12:00 GMP Compliance Project – From the Client Prospective • Communication management, stakeholder engagement and scope

    definition • Case Study: A complicated, fast track HVAC upgrade project

    packaging facility into a successful qualification of the facility • Forming cohesive project team with the tools to deliver and allowing

    for the resumption of supply chain of critical medicines for the region Simone Hurly, Automation Engineer, MSD, South Africa Morgan O’Brien, Business Development Manager, No Deviation Pte Ltd, Singapore

    12:00 Aseptic Process Sampling Risk Mitigation • Complexity and risks of traditional sampling methods • Key drivers for aseptic process sampling • Regulatory recommendations and corresponding needs • Key considerations for optimizing sampling plan and best sampling

    options G Somasundaram, Head of Technology Management, Singapore, Southeast Asia & Oceania, Merck Life Science, Singapore

    12:30 How Can Automation and Digita

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