2024 ISPE Singapore Affiliate Conference & Exhibition

9:00 am - 9:30 am - 29 August 2024

Welcome Session Day 1

Plenary - ISPE Singapore Affiliate Conference & Exhibition - ONSITE @ SUNTEC SINGAPORE & Livestreamed - Room 1

9:00 am

Welcome from ISPE

Alfonsus Karli, President & Regulatory Chair, ISPE Singapore Affiliate & Director, GCMC Vaccines, Pfizer, Singapore

Jörg Zimmermann, Past Chair, ISPE; Vice President External Affairs; Vetter Pharma Fertigung GmbH & Co KG, Germany

9:05 am

Chair’s Opening Remarks

Shanshan Liu

Watch

Shanshan Liu, Conference Chair, ISPE Singapore Affiliate & Technical Director, No deviation, Singapore

9:10 am

Overview of WHO GMP Inspections in Asia

Vimal Sachdeva

Watch

Vimal Sachdeva, Senior GxP Inspector, WHO, Switzerland

9:30 am - 10:15 am - 29 August 2024

Sustainable Pharma Track

Plenary - Sustainable Pharma - ONSITE @ SUNTEC SINGAPORE & Livestreamed - Room 1

9:30 am

OPENING PANEL: Re-Imagining a Sustainable Pharma: Harmonisation, Reliance, Convergence

Vimal Sachdeva, Jessica Hale, Ellen, Ying-Hua Chen, Shanshan Liu, Jörg Zimmermann

Watch

Moderator:

Shanshan Liu, Conference Chair, ISPE Singapore Affiliate & Technical Director, No deviation, Singapore

Panellists:

Jessica Hale, Global Regulatory Affairs & Clinical Safety, Merck, USA

Ellen Ying-Hua Chen, Deputy Director of Quality Compliance and Management, TFDA, Taiwan
Vimal Sachdeva, Senior GxP Inspector, WHO, Switzerland
Jörg Zimmermann, Past Chair, ISPE; Vice President External Affairs; Vetter Pharma Fertigung GmbH & Co KG, Germany

10:15 am - 11:00 am - 29 August 2024

Networking Break

Break - ISPE Singapore Affiliate Conference & Exhibition

11:00 am - 11:45 am - 29 August 2024

Regulatory Track

Plenary - Regulatory Track - ONSITE @ SUNTEC SINGAPORE & Livestreamed - Room 1

11:00 am

Chair’s Opening Remarks

Vee Revithi

Watch

Vee Revithi, Senior Consultant to Pharmaceutical Regulatory Authorities on GMP, GDP; Greece

11:05 am

Regulation | Reliance | Recognition - TGA and Manufacturing for Supply in Australia

Jennifer Burnett

Watch

Jennifer Burnett, Assistant Secretary, Manufacturing Quality, TGA, Australia

11:25 am

PMDA Update – GMP Regulatory Requirements in Japan

Kentaro Hara

Watch

Dr Kentaro Hara, Division Director, Division of Inspection for Drugs I, Office of Manufacturing Quality for Drugs, PMDA, Japan

11:45 am - 12:30 pm - 29 August 2024

Regulatory Roundtable

Roundtable - Regulatory Track - ONSITE @ SUNTEC SINGAPORE & Livestreamed - Room 1

11:45 am

REGULATORY ROUNDTABLE: International Harmonization and Reliance

Kentaro Hara, Vimal Sachdeva, Ellen, Ying-Hua Chen, Jennifer Burnett, Bob Tribe, Chong Hock Sia

Watch

Moderator:
Bob Tribe, ISPE Singapore Regulatory Affairs Advisor, Australia

Panellists:

Chong Hock Sia, Director (Quality Assurance) & Senior Consultant (Audit & Licensing), Health Products Regulation Group, Health Sciences Authority, Singapore

Dr Kentaro Hara, Division Director, Division of Inspection for Drugs I, Office of Manufacturing Quality for Drugs, PMDA, Japan

Jennifer Burnett, Assistant Secretary, Manufacturing Quality, TGA, Australia

Ellen Ying-Hua Chen, Deputy Director of Quality Compliance and Management, TFDA, Taiwan
Vimal Sachdeva, Senior GxP Inspector, WHO, Switzerland

12:30 pm - 1:45 pm - 29 August 2024

Lunch & Exhibition Visit

Break - ISPE Singapore Affiliate Conference & Exhibition

12:30 PM - 1:30 PM:

ISPE CoP Combined Lunch

LUNCH ‘n LEARN Workshop 1: Powering Sustainable Pharma Manufacturing with Digital Twin hosted by Siemens - Room 329

LUNCH ‘n LEARN Workshop 2: Comprehensive Approach to Future Lab Design - Flexible, Digital and Robotic Solutions hosted by EXYTE - Room 328

1:45 pm - 3:10 pm - 29 August 2024

Digital Transformation / Pharma 4.0 Track

Plenary - Digital Transformation / Pharma 4.0 - ONSITE @ SUNTEC SINGAPORE & Livestreamed - Room 1

Track Sponsor:

1:45 pm

Chair’s Opening Remarks

Wee Ming Chua

Watch

Wee Ming Chua, Associate Vice President, NNIT Singapore

1:50 pm

From Programming to Low Code/No Code, Aided by AI

Shaokai Hong

Watch

Shaokai Hong, Digital Transformation APAC, Tulip Interfaces, Singapore

2:10 pm

Pharma 4.0+: Reimagining the Automation with Intelligence

Pinghong He

Watch

Dr Pinghong He, Design & Sustain Director, Johnson & Johnson, Singapore

2:30 pm

Unlocking Value with GenAI: Case Studies in Pharma

Venkatesh (Venkat) Arunachalam

Watch

Venkatesh Arunachalam, General Manager APAC, Cognizant, Singapore

2:50 pm

Digital Innovation: DDL Case Study

Jessica Hale

Watch

Jessica Hale, Global Regulatory Affairs & Clinical Safety, Merck, USA

3:10 pm - 3:55 pm - 29 August 2024

Digital Pharma Panel

Panel Discussion - Digital Transformation / Pharma 4.0 - ONSITE @ SUNTEC SINGAPORE & Livestreamed - Room 1

3:10 pm

DIGITAL PHARMA PANEL: How Can Automation Help to Achieve Sustainability Goals?

Gilad Langer, Knut Georgy, Jessica Hale, Rajnish Narula, Wilbur Ho, Pinghong He

Watch

Moderator:

Rajnish Narula, Director, Business Excellence, Pfizer, Singapore

Panellists:

Jessica Hale, Global Regulatory Affairs & Clinical Safety, Merck, USA

Dr Knut Georgy, Global Market Manager Process Analytics, Knick Elektronische Messgeräte, Germany
Dr Gilad Langer, Head of DxP (Industry Practice Lead), Tulip Interfaces, USA
Dr Pinghong He, Design & Sustain Director, Johnson & Johnson, Singapore
Wilbur Ho, Senior Director, Digital Manufacturing Operations, Asia Pacific, MSD, Singapore

3:55 pm - 4:35 pm - 29 August 2024

Networking Break

Break - ISPE Singapore Affiliate Conference & Exhibition - ONSITE @ SUNTEC SINGAPORE & Livestreamed - Room 1

4:35 pm - 5:00 pm - 29 August 2024

CQV: AI & Digitalization Track

Plenary - CQV: AI & Digitalization - ONSITE @ SUNTEC SINGAPORE & Livestreamed - Room 1

Track Sponsor:

4:35 pm

Chair’s Opening Remarks

Sanjaya Nanjundaiah

Watch

Sanjaya Nanjundaiah, Tech Lead, Quality & Compliance, No deviation, Singapore

4:40 pm

AI in Commissioning, Qualification & Validation

Pierre Winnepenninckx

Watch

Pierre Winnepenninckx, CQV CoP Lead, ISPE Singapore Affiliate & CEO, No deviation, Singapore

5:00 pm - 5:50 pm - 29 August 2024

CQV: AI & Digitalization Panel

Panel Discussion - CQV: AI & Digitalization - ONSITE @ SUNTEC SINGAPORE & Livestreamed - Room 1

5:00 pm

PANEL: The Good, the Bad, and the Ugly in CQV Practice: Navigating Challenges and Embracing Opportunities

David Margetts, Pierre Winnepenninckx, Jernice Li, Nazema Latiff

Watch

Moderator:

Pierre Winnepenninckx, CQV CoP Lead, ISPE Singapore Affiliate & CEO, No deviation, Singapore

Panellists:

Jernice Li, Associate Director, Global Engineering C&Q, Lonza, Singapore
Nazema Latiff, Associate Director – FE, Wuxi Biologics, Singapore
David Margetts, CEO, Factorytalk, Thailand

5:45 pm

Chair’s Remarks

Sanjaya Nanjundaiah

Sanjaya Nanjundaiah, Tech Lead, Quality & Compliance, No deviation, Singapore

5:50 pm - 7:00 pm - 29 August 2024

Pharmanite Networking

Session - ISPE Singapore Affiliate Conference & Exhibition

Open to all!

About

Sponsor/Exhibit 2025

2024 Programme

Venue / Accommodation

Programme

Day 1

Day 2

Welcome Session Day 1

Welcome from ISPE

Chair’s Opening Remarks

Overview of WHO GMP Inspections in Asia

Sustainable Pharma Track

OPENING PANEL: Re-Imagining a Sustainable Pharma: Harmonisation, Reliance, Convergence

Networking Break

Regulatory Track

Chair’s Opening Remarks

Regulation | Reliance | Recognition - TGA and Manufacturing for Supply in Australia

PMDA Update – GMP Regulatory Requirements in Japan

Regulatory Roundtable

REGULATORY ROUNDTABLE: International Harmonization and Reliance

Lunch & Exhibition Visit

Digital Transformation / Pharma 4.0 Track

Chair’s Opening Remarks

From Programming to Low Code/No Code, Aided by AI

Pharma 4.0+: Reimagining the Automation with Intelligence

Unlocking Value with GenAI: Case Studies in Pharma

Digital Innovation: DDL Case Study

Digital Pharma Panel

DIGITAL PHARMA PANEL: How Can Automation Help to Achieve Sustainability Goals?

Networking Break

CQV: AI & Digitalization Track

Chair’s Opening Remarks

AI in Commissioning, Qualification & Validation

CQV: AI & Digitalization Panel

PANEL: The Good, the Bad, and the Ugly in CQV Practice: Navigating Challenges and Embracing Opportunities

Chair’s Remarks

Pharmanite Networking