Speakers
Meet Our Speakers
Conference Tracks
Keynote Speakers
President and CEO
FUJIFILM Biotechnologies
Chair of the Board of Directors
Healthcare Denmark
EVP and Global Head of Pharma Technical Operations
Roche
Group Vice President, Global Parenteral Products and Devices
Eli Lilly and Company
Vice President Consulting: AI & Digital Policy, Real-World Research
Parexel International
Head of Information Management Division
EMA
Lead Scientific Officer
EMA
Expert GMP Inspector
MHRA
General Sessions
Executive Chair
SVP Head of Global Engineering
Takeda Pharmaceuticals International AG
Lead Scientific Officer
EMA
Senior Fellow, Pharmaceutical Process| Sr. Associate
CRB
International Board Liaison
Global Lead, Site Engineering, Synthetics
Johnson & Johnson
Conference Chair
Technology Manager Biotechnology
CRB Group GmbH
Women in Pharma® Liaison
Strategic Marketing Manager
CRB
Senior Assessor Biopharmaceuticals
CBG-MEB
MSAT | Scientist |
Novo Nordisk
CEO
K2P PharmaCon
Head of Quality and Safety of Medicines
EMA
Emerging Leader
Process Engineer MS&T Drug Substance
Takeda
Strategic Advisor
LifeBee | a ProductLifeGroup Company
Market Compliance Manager & Senior GMP Inspector
Health Products Regulatory Authority (HPRA)
Affiliate Liaison
Sales Director
BWT Pharma & Biotech AB
VP European Operations
ISPE
Interactive Forums
Senior Medicines and Medical Device Shortage Specialist
European Medicines Agency
Senior Advisor, Quality & Compliance
F. Hoffmann-La Roche Ltd
Project Director and Office Head With CRB
CRB
Digital Strategy Delivery Specialist
Roche
Principal Project Lead
Merck KGaA
Senior Assessor Biopharmaceuticals
CBG-MEB
Head of Quality and Safety of Medicines
EMA
Senior Engineering Specialist
Novo Nordisk
Senior Director
Sanofi
Senior Director (Engineering Tech Centre)
Eli Lilly
Director of Operational Readiness
Agile GXP Advisors
PhD Student
University of Manchester
President
HPFM Inc.
Partner
McKinsey & Co
Department Head, Dept. Digital Twin Engineering
Fraunhofer IESE
Senior Vice President of International Operations; Sr. Associate
CRB
Global Head of Digital, AI & Operational Excellence (interim)
Roche
Track 1: Digital Compliance
Director of Quality By Design
QbDVision, Inc.
AI Validation Lead
Kuatro Group
Software Engineer & Science Lead
Grit42
Operational Technology (OT) Compliance Lead
Takeda Pharmaceuticals International AG
Chief Product Officer
Valkit.Ai
Life Science Quality Advisor
AMBIT Iberia
Computer System Validation (CSV) Specialist and Digital Validation Expert
Kneat
Founder and CEO
ProcellaRX
Lead Quality Manager
Bayer AG
Director Quality Assurance - Process Performance & System Compliance
Vetter Pharma-Fertigung GmbH & Co KG
Global Quality Assurance and CSV Practice Lead
Accenture Solutions Pvt Ltd
Data Scientist
Syncwork AG
Manager CQV and Digital Validation EU
No Deviation
Director Auditing & Quality Consulting
CirQum
Director of GRC
GlobalVision
Vice President Global Operations
Körber Pharma Consulting GmbH
CEO
RiskCortex.Ie
Chief Technical Officer
Centenarian Technologies
Senior Compliance & Digital Transformation Manager in Life Sciences
AMBIT Iberia
Head of IT Compliance Solutions
UCB
Lead IT Validation & Compliance Partner
Novo Nordisk
Track 2: Pharma 4.0™ In Action
Program Lead Digital Supply Transformation
Boehringer Ingelheim Vetmedica GmbH
Partner - Operations
Transformation Wood - Digital Consulting
Global Development CMC Biologicals
Boehringer Ingelheim Pharma GmbH & Co. KG
Assoc Dir - Advanced Technology
Novo Nordisk
Chief Executive Officer
Optipeople
Senior Fluid Mechanics Specialist
Aerotak
Principal Project Lead
Merck KGaA
Director of Advanced Therapies and Biologics
PM Group
Technical Account Manager, Life Sciences
Omron
Managing Director
MTP4Pharma® - Plug & Produce for Smart Manufacturing - Intrinsic Quality & Compliance
Director Business Line Digital Solutions
ZETA GmbH
Director Engineering
Eli Lilly SA Irish Branch
Technical Account Manager
Siemens Digital Industries Software
Automation Manager
Wood Italiana
Digitalization Specialist Lead
Xellia
Senior Director, CMC Excellence
GSK
Leader of Individualised Medicine Digitalisation
Biontech
Senior Manager CoE Product Robustness & Data Science
Ferring International Center SA
Scientific Advisor
SmartSkin Technologies
CTO & Co-Founder
Cellular Origins
Senior Collaborations Manager
Catapult Cell and Gene Therapy
Technical Support Engineer
Sanofi
Track 3: GEP & GMP Compliant Project Delivery
GMP Services Global Sales Manager
Syntegon Telstar
Quality Director
Farmak
Principal Consultant
Io-consultants GmbH & Co. KG
Director
Chapman Architects
Director of Operations
J&J Innovative Medicines
Global Lead Engineering Compliance
Johnson & Johnson
Partner
Io Consultants GmbH & Co. KG
Senior Engineering Project Manger
Sandoz
Senior Process Architect
PM Group
Strategic Initiatives and Operations Integration Site Lead
Johnson & Johnson
CQV PM
GSK
Industry Practice Lead
Tulip
Site Contamination Control Lead
Eli Lilly
Global Change Facilitator (Project Leader)
BioPhorum
Director IT
Eli Lilly
Sr. Global MSAT Engineer and Operations Strategy Leader
Thermo Fisher Scientific
Co-Director
Chapman Architects
Corporate Director Process Engineering
VTU Engineering GmbH
Track 4: Sustainability & Substances of Concern
Global Head of Product Sustainability and Stewardship
Takeda
Senior Process Engineer
Fluor S.A
Technical Services Lab Manager
STERIS Corp
Associate Director in Business Transformation & Innovation
Johnson & Johnson
Director of Business Development
Syntegon
Director I, Process/Specialty Engineer
Fluor Life Sciences
Cleaning Validation Engineer
Hyde Engineering and Consulting
Director of Operational Readiness
Agile GXP Advisors
Senior Director, CMC Excellence
GSK
Director, Science Policy
EFPIA
Senior QA Manager
Merck
Manufacturing Associate II
Abzena
Fellow Process Utilities
CRB Group GmbH
Head of Global Sustainability
Fujifilm
Project Manager
Novo Nordisk A/S
Senior Process Engineering Specialist
IPS-Integrated Project Services
Track 5: Regulatory and Quality
Director Regulatory Affairs - CMC
Amgen Inc.
Senior Director, CMC RA
Gilead Sciences
Research Associate & PhD Candidate
University of St.Gallen
Global Policy Associate Director
NovoNordisk
Senior Director External Advocacy Europe and Middle East
F. Hoffmann-La Roche Ltd in Basel
Senior Director
Sanofi
Policy Lead Technical Regulatory Policy
F. Hoffmann-La Roche AG
Technical Director - GMP / Regulatory Compliance
PM Group
Vice President, Global Head of Regulatory Intelligence & Policy
Boehringer Ingelheim
President
HPFM Inc.
Head of Quality, Penzberg Site
Roche
Director
C&E Solutions BV
Director, CMC Advocacy and Policy
GSK
Sponsored Sessions
Life Sciences Sustainability Director
Jacobs Italia SpA
Associate Vice President Operational Readiness/ Operational Excellence
CAI
Industry Principal- Life Sciences
AVEVA
Segment Director - Life Science
Schneider Electric
Pharma Business Development Director
SANI Membranes A/S
International Business Relations
Ortner Reinraumtechnik GmbH
Field Application Specialist FMT
Sartorius
ELife Sciences Director, Digital Transformation and Strategic Partnerships
EConsulting Sp. Z O.O.
Co-founder & CEO
Mithryl