Speakers
Meet Our Speakers
Keynotes
Patient Advocate
Patient Advocate
Expert GMP Inspector
MHRA
Head of Quality and Safety of Medicines
EMA
Associate Director, KojoX & Technology Development
FUJIFILM Diosynth Biotechnologies
Senior Manager, PSC Global Engineering
GSK
Director, Science Policy
EFPIA
General Session
SVP Head of Global Engineering
Takeda Pharmaceuticals International AG
Vice President Technical
Parexel
Lead Senior GMDP Inspector
MHRA
Head of Operations Quality Compliance and External Affairs
AstraZeneca
Lead Scientific Officer
EMA
Senior Fellow | Director of Pharmaceutical Process Technology
CRB
Consultant
BiggsB
Senior Vice President Global Engineering Innovation
CSL Behring
Expert GMP Inspector
MHRA
Process Engineer MS&T Drug Substance
Takeda
CEO and Co-Founder
Pharmaxi LLC
Student
University of New Hampshire
Contracts Manager
FFG Group of Companies
Qualified Person - Plant Manager
Lab. GP-Pharm
GMP Inspector
AGES - Austrian Agency for Health and Food Safety
Founder & CEO
LifeBee | a ProductLifeGroup Company
Affiliate Chair
ISPE Affiliate Czech Republic/Slovakia
Market Compliance Manager & Senior GMP Inspector
Health Products Regulatory Authority (HPRA)
Deputy Director Standards and Compliance
MHRA
Chief Strategy Officer
CAI
Partner
ProductLife Group
Senior Director Life Sciences
Persistent Systems Limited
Associate Director - Pharmaceuticals & Life Sciences
Mace
Director
TenTenTen Consulting Ltd
VP European Operations
ISPE
Track 1: Sustainability - Legislation/Regulatory
Principal Mechanical Building Services Engineer
Scitech Engineering
Manager Sustainability & Energy Management
Rockwell Automation
Phorum Director Supply Resilience
Biophorum
Head of Global Physical Asset Management and Real Estate
UCB
Regulatory & External Partnership Manager
BioPhorum
Head Life Sciences Process Department
Technip Energies
Global HVAC Systems Lead
GlaxoSmithKline Biologicals
Customer Application Engineer
OPTIMA Pharma GmbH
Senior Principal Scientist
J&J
Group Sustainability SME
PM Group
Technology Lead
Takeda Pharmaceuticals International AG
Group Technical Director Building Services Engineering
PM Group
Academy Research Fellow in Environmental Law
University of Eastern Finland
HVAC SME
Jacobs Italia SpA
Senior Global Change Facilitator
BioPhorum
Technical Director - GMP / Regulatory Compliance
PM Group
Senior Director, CMC Excellence
GSK
SME Sustainability and Green Engineering
VTU Engineering
Track 2: Pharma 4.0 / Digital Transformation
Site Head, Parenteral Drug Product and Device Manufacturing
Eli Lilly Italia SpA
Head of Digital Transformation
Koerber
Small Molecule OpU Lead, Commissioning, Qualification and Validation
Takeda Pharmaceuticals International AG
Senior Manager
Deloitte GmbH WPG
Principal Scientist in the Drug Product Formulation Department
Ten23 Health AG
Head of Advanced Technologies
PQE Group
Senior Business Manager - Digital Traceability Platform
BD Medical - Phamaceutical Systems
Managing Director
Crypto Pharma
Head of Global Account Development
ZAHORANSKY AG
Head of Global Robotics & Tech Innovation
Novo Nordisk
Director of Validation
GWWO Grifols
Senior Director External Advocacy Europe and Middle East
F. Hoffmann-La Roche Ltd in Basel
Chief Commercial Officer (CCO)
Eltronic A/S
Director, GRA Digitalization Lead
CSL Behring AG
CEO, Co-Founder
Plus10 GmbH
Executive Vice President - Partner
PQE Group
C&Q Digital Transformation Manager
No Deviation
Principal Process Technology Engineer
CSL Behring
Senior Director, CMC Excellence
GSK
Business Development Manager
OMRON Electronics A/S
Head of Digital Solutions
SIGMA Process & Automation GmbH
Data Management Scientist
Takeda
Technical & Laboratory Operations Manager, Group Quality Assurance
Famar
Portfolio Manager
ZETA GmbH
Track 3: GAMP
Chair of the UK GAMP Community of Practice
QA Manager
MAASI Enterprises
Consultant GMP Regulations
Siemens AG, DI PA PHA
Independent
Managing Director
Q-FINITY Quality Management
Managing Director
Northern Life Sciences Ltd.
Senior Director, Manufacturing R&D
Charles River Laboratories Inc
Principal Consultant
JDI Digital Transform LTD
Managing Director
MTP4Pharma® - Intrinsic Plug & Operate Compliance
Director, Global Quality Solutions
OPDC
Partner
ProductLife Group
Senior Compliance & Digital Transformation Manager in Life Sciences
AMBIT-BST
Vice President, Corporate Quality
Syneos Health
CSV/CSA Skill Master
MAASI Enterprises
Software Developer/R&D Manager
Siena Imaging
Lead Consultant
PLG Consulting & Digital
Senior Manager Quality
Amneal Ireland Ltd
Director
Conformity Ltd.
Track 4: Biotech - Large Molecules, Cell & Gene, ATMPs
Global Pharma Chief Technology Leader
Wood Plc
Managing Director
PSM GmbH Topmedicare
Technical Service Manager
STERIS
Technical and Business Program Lead
Chiesi Farmaceutici
Global Account Manager
Staubli Robotic UK
Business Development
Pfizer
Process Engineering Department Manager
Arcadis
Technical Director
MilliporeSigma
Managing Director for Quality
Catapult Cell and Gene Therapy
Strategic Product Manager
Skan AG
Process Cleaning Engineer
Eli Lilly
Technical Director - GMP / Regulatory Compliance
PM Group
Business Development Director
3P Innovation
Global Change Facilitator (Project Leader)
BioPhorum
Director of Technology
Evolve Biologics
CTO & Co-Founder
Cellular Origins
Sr. Associate Director Quality Control
Boehringer Ingelheim
Manager
Fraunhofer IPA
Senior Collaborations Manager
Catapult Cell and Gene Therapy
Manager Manufacturing Technology
Incyte Biosciences
Advisor- QA- Global Quality Systems
Eli Lilly & Company
Track 5: Good Engineering Practice - Investment Management
Director Technical Services / Manufacturing Science
Eli Lilly
Group CI/HSE/ENG Director
FAMAR
Digital Plant Representative
Eli Lilly
Small Molecule OpU Lead, Commissioning, Qualification and Validation
Takeda Pharmaceuticals International AG
Senior Director, Global Quality Engineering
CSL Behring
Global Drug Product (DP) Fleet Quality Owner
F Hoffmann-La Roche AG
Project Manager
NovoNordisk
Vice President of Quality
Kindeva Drug Delivery
Lead Manufacturing Science
Takeda
Project & Technology Manager ATMP
CRB
Account Manager & Global Change Facilitator
BioPhorum
Managing Consultant, Compliance Consulting
NNE
Lecturer and Head of Project Management Department
University of Applied Science BFI Vienna
Principal Engineer
Eli Lilly
Front-End Engineering & Funding Manager
GSK Vaccines
Projects and Engineering Manager
EURO API
Managing Director
Innerspace GmbH
Owner and Founder
Condots
Fleet Program Owner, Drug Product Equipment
F Hoffmann-La Roche
Pharma Technology Systems Lead
Bayer
President
MAASI Enterprises
Workshops
Lead External Advocacy North America (Quality Policy)
Genentech, A Member of the Roche Group
Student
Newcastle University 2023-2026
Head of Product Sustainability and Stewardship
Takeda
GMP Inspector
MHRA
Senior Medicines and Medical Device Shortage Specialist
European Medicines Agency
Principal Expert Filtration
Sartorius Stedim Biotech GmbH
Fellow - Digital Technology, Associate
CRB
Regulatory Advisor
ISPE
Head Chemical and Environmental Legislation
F. Hoffmann-La Roche AG
Manufacturing IT & Continuous Improvement Senior Director
Lilly
Associate Director-US & Global Regulatory Affairs
Merck & Co Inc
Independent
Senior Executive Consultant
Q-FINITY Quality Management
Senior Assessor Biopharmaceuticals
CBG-MEB
Executive Director, Regulatory Affairs
Merck & Co., Inc.
VP Materials & Surface Technologies
Datwyler Pharma Packaging Belgium NV
Principal Consultant
Saige Digital & Quality Transformations
Senior Advisor - Chemicals Management
Eli Lilly
Head Advanced Process Modeling and Control
Takeda
North American Supply Chain Lead for COVID-19
Janssen
Global Data Analytics Senior Director
Roche
Senior Director, CMC Excellence
GSK
Director, Science Policy
EFPIA
Founder | Managing Partner
The Triality Group, LLC
Managing Director
Memo3 GmbH
Executive Industry Advisor
Körber Pharma Software GmbH