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Keynote Speakers


Maria Jesus Lamas Diaz
Director
AEMPS (Spanish Agency of Medicines and Healthcare Products)
Evdokia Korakianiti
Head of Quality and Safety of Medicines
EMA
Christoph Prinz
Vice President Global Operational Quality
BioNTech
Teresa Minero
Founder & CEO
LifeBee - Digitalizing Life Sciences
Christian Wölbeling
Executive Industry Advisor
Körber Pharma Software GmbH

Keynote Regulatory Panel


Evdokia Korakianiti
Head of Quality and Safety of Medicines
EMA
Manuel Ibarra Lorente
Head of Pharmaceutical Inspection & Enforcement Department
AEMPS (Spanish Agency of Medicines and Healthcare Products)
James Pound
Deputy Director Standards and Compliance
MHRA
Joel Welch, PhD
Associate Director for Science, Office of Biotechnology Products (OBP)
FDA
David Churchward
Global Head Sterility Assurance, Cell and Gene Technologies
Lonza Biologics
Moderator
Yvonne Duckworth, PE
Fellow - Digital Technology, Associate
CRB
Moderator

Annex 1, ATMPs and Pharma 4.0 - How Do They Fit Together Speakers


Johannes M. Rauschnabel, PhD
Director Advanced Technology Development and Innovation
Syntegon Technology GmbH
Sebastian Scheler
Managing Director
Innerspace GmbH
Serena Steidl
Advisory Specialist
Particle Measuring Systems

Quality 4.0 • Advancing Pharmaceutical Quality Through Process, Data and Organisation Speakers


Heike Roeder
Vice President QA International
Cencora
Line Lundsberg-Nielsen, PhD
Managing Consultant, Compliance Consulting
NNE
Paige E. Kane, PhD, CPIP
Director Knowledge Management
MSD
Teresa Minero
Founder & CEO
LifeBee - Digitalizing Life Sciences
Maria Amaya
Lead External Advocacy North America (Quality Policy)
Genentech, A Member of the Roche Group
Thomas Zahel, PhD
Head of Innovation
Körber Pharma Austria GmbH

Annex 1 Implementation Between GXP Compliance and Cost Containment Speakers


Christoph Bohn
Director
Rommelag Pharma Service
David Alonso
Sterility Assurance Technician
Boehringer Ingelheim
Morcos M. Loka
Quality Senior Manager Biologics F&F and New Projects
Minapharm
Sergi Solano
Engineering Manager
Boehringer Ingelheim
Thomas Obenauer
Product Manager
Rommelag AG
Xavier Gomez
Lyophilization Product Manager
Telstar

Production 4.0 - Digital Supply Chain & Manufacturing Operations Speakers


Katja Hoppmann
Senior Project Manager Smart Manufacturing
Merck KGaA
Martin Mayer
Director Business Line Digital Solutions
ZETA GmbH
Robert Tod Urquhart
Executive Industry Adviser
CIM A/S
Simon Webb
Founder & CEO
Liminos

Equipment Innovation and Annex 1 Implementation Speakers


Amanda Gilabert
Focused Factory Respimat Manager
Boehringer Ingelheim
Patrick Wieland
Global Lead Business Development
Bausch+Ströbel SE + Co. KG
Richard Denk
Senior Consultant Aseptic Processing & Containment
SKAN AG
Ryan W. Waldhart
Senior Manager of Manufacturing Science & Technology
Grand River Aseptic Mfg Inc
Svetlana Kiseleva
Chief Marketing Officer
Plair SA

Pharma 4.0 Enabling Technologies: Use Cases, Benefits and Constraints Speakers


Christoph Koeth
Director Innovation
Fresenius Kabi Austria GmbH
Daniela Pinter
Master Student..
University of Graz
Edoardo Schiraldi
Corporate Program Manager
Menarini
Gitte Bjørg Windfeldt
Head of Data Science, Digital Transformation & Technology, PSQIT TEC
Novo Nordisk A/S
Sara Del Carlo
Quality Control Sr. Manager & Qualified Person
Kedrion BioPharma
Alessandro Sciacca
Project Delivery Senior Manager
Johnson & Johnson
Alessandro Zanotti
Manufacturing & Packaging Project Delivery Manager
Johnson & Johnson