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Factories of the Future: Back-up Manufacturing, Contingency Plans, More Local API Production?
Industry's and Regulators' View on COVID-19: Impact on Industry and Regulation
New Trends in CQV and Impact on Project Delivery in Times of Corona Crisis
Factories of the Future: Back up Manufacturing, Contingency Plans, More Local API Production?
Factories of the Future: Back-up Manufacturing;Contingency Plans;More Local API Production?
Contamination and Cross Contamination Control for Bio Safety
Facility Considerations for Next-Generation Sterile Product Manufacturing
Containment: Understanding Why, When, and What Regulatory Agencies Expect
PLENARY SESSION: The revision of EU GMPs Annex 1: What impacts can we expect as an industry?
INTERACTIVE REGULATORY PANEL: Potential Topic – COVID-19 (Supply Chain, Vaccines, Aseptic)
Track 1: Pharma 4.0™ in Biotechnology Accelerated by Digitalisation
Track 2: Operations Readiness, Technology Transfer and Risk based Case Studies
Track 3: Cell and Gene Therapy Products, ATMPs, Projects, Commercial Manufacturing
Track 4: Cell and Gene Therapy, ATMPs, Data Science Research and Development
Track 6: mABs: Continuous BioManufacturing, Technology Enablers & Rationalisation
Track 2: Quality 4.0 • The New Dimension of Quality Through Process and Data Science
Track 3: ATMPs/C>s: From Concept to Commercialisation
DateJune 27, 2023Along the “Wild Atlantic Way” in the West of Ireland, a unique and established supply chain has been in operation over several years to procure, manufacture and deliver GMP approved clinical therapy (ATMP) products to patients…Speaker
General Manager, Centre of Cell Manufacturing Ireland
DateJune 27, 2023Advanced Therapy Medicinal Products are a new treatment modality in the pharmaceutical industry. APC Ltd, Dublin, is one of the world’s leading pharmaceutical process engineering research and development companies. Recently, APC Ltd…Speaker
Senior Scientist, APC
DateJune 27, 2023Takeda voted FOYA (Facility of the year Award) Winner 2022 - Presenting the many Innovative Solutions that have been adopted by Takeda to support the Supply Chain challenges faced in delivering a unique and life changing product to patients…Speaker
Operational Excellence AGILE Champion, Takeda Ireland Limited (Grange Castle)
DateJune 27, 2023Flexible manufacturing equipment and process flows can now support many distinct production modalities…Speakers
European Director of Process Technology, ArcadisStrategic Solutions Leader, Arcadis
DateJune 27, 2023This presentation will give an insight of a viral vector project for a client at the German CDMO PSM GmbH…Speaker
Vice President Business Development, PSM GmbH
DateJune 27, 2023This session will provide an overview of ATMP manufacturing, particularly Yescarta. It will emphasize the regulations, design challenges, process flows, and GMP equipment…Speakers
Division Manager of Process Engineering, Life Sciences, TAI EngineeringProcess Engineer, TAI Engineering
DateJune 27, 2023Session Leaders
Senior Consultant Aseptic Processing & Containment, SKAN AGAntonio R. Moreira, PhDVice Provost, Academic Affairs, University of MarylandScientist, Janssen Biologics (Ireland)ISPE Student Chapter Munich, Technische Universität MünchenSpeakers
Vice President Business Development, PSM GmbHPeter Marks, MD, PhDDirector, Center for Biologics Evaluation and Research, CBER/FDADivision Manager of Process Engineering, Life Sciences, TAI EngineeringGeneral Manager, Centre of Cell Manufacturing IrelandOperational Excellence AGILE Champion, Takeda Ireland Limited (Grange Castle)Strategic Solutions Leader, ArcadisEuropean Director of Process Technology, ArcadisProcess Engineer, TAI EngineeringSenior Scientist, APCGMP Policy Manager, HPRA
