2023 ISPE Singapore Affiliate Conference & Exhibition

Gerard Dempsey, Executive Director, Head of Asia Pacific Regional Supply Chain, Amgen, Japan

Nowadays, business complexities are evolving at a rapid pace and we tend to respond by engaging in transformation of our supply chains. The perpetuity of reinventing our supply chains can be laborious, but are we truly delivering an optimal output for our stakeholders and customers, or are we just reacting and coping to overcome business headwinds?

10:35 am - 11:00 am - 23 August 2023

Keynote 3

Keynote - 2023 ISPE Singapore Affiliate Conference & Exhibition - Virtual Room 1

10:35 am

KEYNOTE: ISPE Drug Shortages Prevention Model

Diane L Hustead - Executive Director, Regulatory Affairs & Drug Shortage Initiative Team Chair, ISPE - Merck & Co, Inc

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Diane L Hustead, Executive Director, Regulatory Affairs, Merck & Co, Inc, & Drug Shortage Initiative Team Chair, ISPE, USA

11:00 am - 11:10 am - 23 August 2023

Stretch Break

- 2023 ISPE Singapore Affiliate Conference & Exhibition

11:10 am - 11:35 am - 23 August 2023

Regulatory Keynote 1

Keynote - 2023 ISPE Singapore Affiliate Conference & Exhibition - Virtual Room 1

11:10 am

Chair’s Remarks

Bob Tribe - Asia Pacific Regulatory Affairs Advisor - ISPE

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Bob Tribe, ISPE Singapore Regulatory Affairs Advisor, Australia

11:15 am

REGULATORY KEYNOTE: PIC/s Update

Jacques Morénas - Technical Advisor of the Inspection Division Director - ANSM, Agence nationale de sécurité du médicament et des produits de santé

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Jacques Morenas, Deputy Chair & Chair, Training sub-committee, PIC/s & Technical Advisor, Inspection Division, ANSM, France

11:35 am - 12:00 pm - 23 August 2023

Regulatory Keynote 2

Keynote - 2023 ISPE Singapore Affiliate Conference & Exhibition - Virtual Room 1

11:35 am

EU Network Approach to Inspection Reliance and Manufacturing Innovation

Andrei Spinei - Manufacturing Team Lead, Inspections Office, Quality and Safety of Medicines Dept - European Medicines Agency

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Andrei Spinei, Manufacturing Team Lead, Inspections Office, Quality and Safety of Medicines Dept, European Medicines Agency, Netherlands

12:00 pm - 12:45 pm - 23 August 2023

Global Panel

Panel Discussion - 2023 ISPE Singapore Affiliate Conference & Exhibition - Virtual Room 1

12:00 pm

GLOBAL PANEL: Regulatory, Policy & Industry Approach to Combat Drug Shortages

Jesusa Joyce N. CIRUNAY - Director IV - FDA Center for Drug Regulation and Research (CDRR), Gerard (Gerry) Dempsey - Executive Director, Head of Asia Pacific Regional Supply Chain - Amgen, David Churchward - Global Head Sterility Assurance, Cell and Gene Technologies - Lonza Biologics, Mr Vimal SACHDEVA - Technical officer (Senior GMP Inspector) - World Health Organization, Rich Pelt - Senior Director, Vaccines CMC Regulatory Affairs - Pfizer Inc, Diane L Hustead - Executive Director, Regulatory Affairs & Drug Shortage Initiative Team Chair, ISPE - Merck & Co, Inc

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Moderator:

Diane L Hustead, Executive Director, Regulatory Affairs, Merck & Co, Inc, & Drug Shortage Initiative Team Chair, ISPE, USA

Panellists:

Joyce N. Cirunay, Director IV, FDA Center for Drug Regulation and Research (CDRR), Philippines

Vimal Sachdeva, Senior GxP Inspector, WHO, Switzerland

David Churchward, Global Head Sterility Assurance, Cell and Gene Technologies, Lonza Biologics, UK

Gerard Dempsey, Executive Director, Head of Asia Pacific Regional Supply Chain, Amgen, Japan

Rich Pelt, Senior Director, Vaccines CMC Regulatory Affairs, Pfizer, USA

12:45 pm - 1:00 pm - 23 August 2023

Stretch Break

- 2023 ISPE Singapore Affiliate Conference & Exhibition

1:00 pm - 1:10 pm - 23 August 2023

Track A: Welcome Session

Concurrent - Track A: Industry Best Practices - Virtual Room 1

Track Sponsor:
Fedegari

1:00 pm

Chair’s Opening Remarks

Jen Chen - Quality Assurance Manager - Schneider Electric

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Jen Chen, QA/QC Manager, Schneider Electric, Singapore & Conference Co-Chair, ISPE Singapore

1:00 pm - 1:10 pm - 23 August 2023

Track B: Welcome Session

Concurrent - Track B: Digital Transformation - Virtual Room 2

Track Sponsor:
Lachman

1:00 pm

Chair’s Opening Remarks

Frances Zipp - President & CEO - Lachman Consultants

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Frances M Zipp, President & CEO, Lachman Consultant Services, Inc, USA

1:10 pm - 1:35 pm - 23 August 2023

Track A:

Concurrent - Track A: Industry Best Practices - Virtual Room 1

1:10 pm

Critical Thinking – The what, why and how…

Benjamin Sauer - APAC Lean Academy Lead - AstraZeneca

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Benjamin Sauer, APAC Lean Academy Lead, AstraZeneca, Australia

- Defining critical thinking
- Neuroscience models related to critical thinking
- Road map for developing critical thinking within teams
- Agile model for critical thinking

1:10 pm - 1:35 pm - 23 August 2023

Track B:

Concurrent - Track B: Digital Transformation - Virtual Room 2

1:10 pm

Has Paper Finally Met Its Match? No-Code Citizen Development for GMP

Bob Buhlmann - Global Head of Digital Quality & Computer Strategy - AstraZeneca, David Holt - Group Managing Director - Factorytalk

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David Holt, Group Managing Director, Factorytalk, Thailand
Bob Buhlmann, Global Head of Digital Quality & Computer Strategy, AstraZeneca, USA

1:35 pm - 2:00 pm - 23 August 2023

Track A: Case Study

Case Study - Track A: Industry Best Practices - Virtual Room 1

1:35 pm

Design of HPAPI Biomanufacturing Facility

Morcos Loka - Training Manager & GMP Advisor - Minapharm

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Morcos Loka, Training Manager & GMP Advisor, Minapharm, Egypt

1:35 pm - 2:00 pm - 23 August 2023

Track B:

Concurrent - Track B: Digital Transformation - Virtual Room 2

1:35 pm

The Nexus: Data Integrity & Pharma 4.0

Mr Scott Deckebach - Senior Director, Data Integrity, Governance & Advanced Digital Technologies - Lachman Consultants, Inc.

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Scott Deckebach, Senior Director, Data Integrity and Governance, Lachman Consultants, Inc., USA

2:00 pm - 2:45 pm - 23 August 2023

Track A:

Concurrent - Track A: Industry Best Practices - Virtual Room 1

2:00 pm

Single-use Technology for mRNA Manufacturing

Somasundaram G - Senior Consultant, Global Biopharm Center of Excellence - Merck Pte Ltd

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mRNA is one of the critical RM in the formulation of vaccines & biotherapeutics. Making this production process more cost-effective and to improve the quality would be the main focus of this session.

Somasundaram G, Senior Consultant, Global Biopharm Center of Excellence, Merck Pte Ltd, Singapore

2:25 pm