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Nov News & Updates

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News


Congratulations to the 2023 ISPE Facility of the Year Award Winners

26 Oct 2023


LabCompare!: Current Trends in Biopharma Facility Engineering

26 Oct 2023


Artificial Intelligence (AI) Based Continued Process Verification (CPV)

4 Oct 2023


Improving the Gold Standard: A New Portal for ISPE Guidance Documents

3 Oct 2023


Technology Transfer for Pharma: One Size Does Not Fit All

1 Oct 2023

Highlights



Cytotoxic Drug Manufacturing Market: Outsourcing, a Preferred Business Model

Nov 2023, PHARMAnetwork magazine 


Sustainable Biosimilar Competition in Europe: Can it be Achieved?

27 Oct 2023, European Pharmaceutical Review 


Proposed Best Practices For Cell & Gene Therapy Aseptic Process Simulation

25 Oct 2023, BioPhorum/Outsourcedpharma.com


Key Developments in Pharmaceutical Manufacturing

12 Oct 2023, European Pharmaceutical Review

FEATURE ARTICLE

MEETING THE EVOLVING DEMANDS OF

BIOPHARMACEUTICAL INDUSTRY:

High-Performance Ionic Cyclic Olefin Polymers (COP) For Advanced Medical Packaging



With the rapid development of the biopharmaceutical industry, there is an increasing demand for pharmaceutical packaging materials. COP (Cyclic Olefin Polymer), as a high-purity and highly transparent new polymer material, has gradually attracted attention in the industry. Compared to glass packaging materials, COP packaging materials have many advantages and are becoming the ideal choice in the fields of small molecule drugs and biopharmaceuticals. Read further


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📢📢 Join the 2024 Executive Committee



We welcome members to join the Singapore affiliate executive committee, which meets on the first Tues monthly.

Volunteer your help, advice, suggestions to support our community in Singapore and beyond.

Nominate Yourself or a Colleague

UPCOMING EVENTS

ISPE Singapore Soccer Tournament

8 Nov 2023

7.00-9.00pm SGT | Golazo Futsal Singapore

Registration Closed!

Member-exclusive!

ISPE Singapore Members Connect - Dinner & Drinks

23 Nov 2023

6.30-8.30pm SGT | Cafe Melba @ Mediapolis (in-person)

REGISTER

ISPE Singapore EU GMP Workshop

14&15 Dec 2023, Ho Chi Minh, Vietnam

Held jointly with VNPCA Vietnam Pharmaceutical Companies Association

Limited sponsor/table top exhibits available. Contact linda.wan@ispesingapore.org for details

ISPE Singapore AGM

25 Jan 2024

6.00-8.00pm | In-person

Nominate / Join the Executive Committee!

REGISTER

ISPE Singapore Conference & Exhibition

SYMPOSIUM DISCUSSION HIGHLIGHTS 2023 

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

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

PANEL: How does GAMP5 Revision Impact the Industry?

Moderator:

Charlie Wakeham, Global Head of Quality and Compliance, Magentus & Co-Chair, ISPE GAMP Global Steering Committee, Lead, ISPE GAMP CSA Special Interest Group, Australia

Panelists:

Gionata Taddeucci, APAC Operations Director – Partner, CSV/CSA & Data Integrity Advisor, PQE, Italy

Subbarao Kattamuri, Head of India Operations, Aztec Process Automation Pvt. Ltd., India

Bob Buhlmann, Global Head of Digital Quality & Computer Strategy, AstraZeneca, USA

David Holt, Group Managing Director, Factorytalk, Thailand

PANEL: Applying Good Practices for the Project Life Cycle

Moderator: 

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

Panelists:

Dr Joerg Block, GMP Compliance Engineering, Bayer AG Pharmaceuticals, Germany

Manuel Ungerer, Head of Site Development, APAC, Novartis, Singapore 

Paul Si, Head of SGIE Delivery APAC, Lonza, Singapore

Calling for Speakers!

Wanted: Case study presenter on: implementation of Annex 1 (considering the task, the impact/benefits etc with a focus on the Cleanrooms, testing or monitoring), and any Asia regulator review. Preferably from pharma, from an engineering / QC/QA or operations perspective. Please contact ispesingapore@ispesingapore.org

RECENT EVENTS

Thirsty Thursday

5 Oct 2023

View Photos

Technical Tuesday: EU Advanced Therapy Medicinal Products (ATMPs) Quality Regulation

10 Oct 2023

View Video

ISPE Singapore Bowling Tournament

26 Oct 2023

View Photos

STERIS Workshop

27 Oct 2023

View Photos

Contact us

ISPE Singapore Affiliate

ispesingapore@ispesingapore.org

Ph +65 6826 1105

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