Registration
Opening Remarks
Keynote Speech
SESSION I: AI/ ML Roundtable Discussion
Nora PatautBen Stevens
  • Nora Pataut (Program Manager at GSK)

    Nora Pataut

    Program Manager at GSK
  • Ben Stevens (Director, CMC Policy and Advocacy of GSK)

    Ben Stevens

    Director, CMC Policy and Advocacy of GSK
Coffee Break at the Exhibition Hall
SESSION II: Facilities: Aging and Newly-Built (Part I)
Aging Facilities: A US-FDA Perspective
Rick Friedman (Invited)
  • Rick Friedman (Invited) (Deputy Director of US Food and Drug Administration)

    Rick Friedman (Invited)

    Deputy Director of US Food and Drug Administration
Q&A Session
Rick Friedman (Invited)
  • Rick Friedman (Invited) (Deputy Director of US Food and Drug Administration)

    Rick Friedman (Invited)

    Deputy Director of US Food and Drug Administration
How to Interact with CDER When Designing A New Facility and High-risk Facilities
Peter Qiu
  • Peter Qiu (External Advocacy Lead, APAC at Roche Genentech)

    Peter Qiu

    External Advocacy Lead, APAC at Roche Genentech
Lunch Break at the Exhibition Hall
SESSION III: Facilities: Aging and Newly-Built (Part II)
Aging Facilities: Industry Perspective
Wallace Torres
  • Wallace Torres (VP Site Operations at Amgen Singapore Manufacturing)

    Wallace Torres

    VP Site Operations at Amgen Singapore Manufacturing
Common Issues When Designing A New Facility/ Upgrading An Old Facility
Peter Qiu
  • Peter Qiu (External Advocacy Lead, APAC at Roche Genentech)

    Peter Qiu

    External Advocacy Lead, APAC at Roche Genentech
Newly-built Facilities: Issues, Successes and Resolutions

Speaker (TBC)

Flexible Manufacturing for Future Pharmaceutical Industry
Kai Yin Po

This presentation dives into the vital role of flexible manufacturing in the future of pharmaceutical drug development and commercialization. It explores two emerging technologies, Portable-on-demand manufacturing (PODs) and Continuous Manufacturing, and how they enable drug manufacturers to enhance flexibility and speed in operations, ensuring critical medicines reach patients worldwide. The discussion delves into the opportunities and regulatory challenges related to these technologies, as well as ongoing policy initiatives encouraging pharmaceutical companies to adopt them.

  • Kai Yin Po (Associate Principal Scientist at MSD International GmbH)

    Kai Yin Po

    Associate Principal Scientist at MSD International GmbH
Panel Discussion and Q&A
Kai Yin PoPeter QiuWallace Torres
  • Kai Yin Po (Associate Principal Scientist at MSD International GmbH)

    Kai Yin Po

    Associate Principal Scientist at MSD International GmbH
  • Peter Qiu (External Advocacy Lead, APAC at Roche Genentech)

    Peter Qiu

    External Advocacy Lead, APAC at Roche Genentech
  • Wallace Torres (VP Site Operations at Amgen Singapore Manufacturing)

    Wallace Torres

    VP Site Operations at Amgen Singapore Manufacturing
Coffee Break at the Exhibition Hall
Session IV: Annex 1 Implementation and Qualification
Update from Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S)
Meow Hoe Boon (Invited)
  • Meow Hoe Boon (Invited) (Deputy Director - OA of Health Sciences Authority of Singapore)

    Meow Hoe Boon (Invited)

    Deputy Director - OA of Health Sciences Authority of Singapore
Particle Counting
Kurt JaecquesBruce Loxley
  • Kurt Jaecques (Senior Advisor, GSK Vaccines Sterility Assurance Centre of Excellence at GlaxoSmithKline Vaccines)

    Kurt Jaecques

    Senior Advisor, GSK Vaccines Sterility Assurance Centre of Excellence at GlaxoSmithKline Vaccines
  • Bruce Loxley (Senior GMP Compliance Advisor at GSK)

    Bruce Loxley

    Senior GMP Compliance Advisor at GSK
Panel Discussion and Q&A
Meow Hoe Boon (Invited)Bruce LoxleyKurt Jaecques
  • Meow Hoe Boon (Invited) (Deputy Director - OA of Health Sciences Authority of Singapore)

    Meow Hoe Boon (Invited)

    Deputy Director - OA of Health Sciences Authority of Singapore
  • Bruce Loxley (Senior GMP Compliance Advisor at GSK)

    Bruce Loxley

    Senior GMP Compliance Advisor at GSK
  • Kurt Jaecques (Senior Advisor, GSK Vaccines Sterility Assurance Centre of Excellence at GlaxoSmithKline Vaccines)

    Kurt Jaecques

    Senior Advisor, GSK Vaccines Sterility Assurance Centre of Excellence at GlaxoSmithKline Vaccines
Registration
SESSION V: Microbiology / Rapid Microbial Monitoring (Part I)
Warning Letters: FDA’s Concerns on Microbiological Contamination on Pharmaceutical Products

John Metcalfe, US FDA (invited)

Q&A Session
Get Out from Behind Your Computer to Conduct Comprehensive EM Investigations

Jamie Kahoohanohano, Microrite

Process and Challenges of Drafting a Science-based CCS
Rebecca Michel
  • Rebecca Michel (Director, Microbiology of Tolmar)

    Rebecca Michel

    Director, Microbiology of Tolmar
Coffee Break at the Exhibition Hall
Session VI: Microbiology / Rapid Microbial Monitoring (Part II)
Moving from Conventional Aseptic to Cell TherapiesLessons Learned

Speaker (TBC)

Updates & Future Looking Statements from USP Microbiology Expert Committee
Edward Tidswell
  • Edward Tidswell (Executive Director, Microbiological Quality and Sterility Assurance of Merck)

    Edward Tidswell

    Executive Director, Microbiological Quality and Sterility Assurance of Merck
Panel Discussion and Q&A
Rebecca MichelEdward Tidswell

John Metcalfe, US FDA (Invited)
Jamie Kahoohanohano, Microrite

  • Rebecca Michel (Director, Microbiology of Tolmar)

    Rebecca Michel

    Director, Microbiology of Tolmar
  • Edward Tidswell (Executive Director, Microbiological Quality and Sterility Assurance of Merck)

    Edward Tidswell

    Executive Director, Microbiological Quality and Sterility Assurance of Merck
Lunch Break at the Exhibition Hall
SESSION VI: Shaping Human Capital in Pharma
Openness Simplifies Everything
Kai Yee Loo

Simplicity is vital for regulatory compliance, patient safety, efficiency and competitiveness. It is important to note that reducing complexity should extend beyond technology and process improvement to interpersonal interactions.

A lack of openness could breed distrust between regulators and companies, hinder collaboration among professionals, and make straightforward matters more complicated to resolve. In contrast, open communication fosters trust. It creates a conducive atmosphere for teamwork, creativity, innovation, and effective problem-solving.

In this presentation, we will delve into factors hindering openness and offer suggestions to enhance it in the workplace.

  • Kai Yee Loo (Director of Teambiosis)

    Kai Yee Loo

    Director of Teambiosis
Future-Proofing Human Capital in Pharma

Mark Chua, Agency for Science, Technology and Research (A*STAR)

Panel Discussion and Q&A
Kai Yee Loo

Mark Chua, Agency for Science, Technology and Research (A*STAR)

  • Kai Yee Loo (Director of Teambiosis)

    Kai Yee Loo

    Director of Teambiosis
Coffee Break at the Exhibition Hall
SESSION VII: ICHQ12/ Quality Manufacturing Maturity (QMM)
Links between ICHQ12 and QMM Initiatives

Djamila Harouaka, US FDA (invited)

Topic TBC

Niraj Mehta, MSD (invited)

Panel Discussion and Q&A

Djamila Harouaka, US FDA (invited)
Niraj Mehta, MSD (invited)

Closing Remarks