PDA Good Digital Manufacturing Conference 2025

CEST Daylight Time (UTC +2:00)

• 08:00 – 17:30

  Registration Open

  Topaz & Topaz Foyer

• 09:00 – 09:10

  Welcome and Introduction

  Ballraum 2&3

  • Committee Member:

    

    Falk Klar, PhD
    General Manager, Vice President Europe, Parenteral Drug Association

• 09:10 – 09:20

  Welcome from the Co-Chairs

  Ballraum 2&3

  • Co-Chair:

    

    Marilyn Romieux
    Strategy Director - Pharma segment, Merck KGaA

  • Co-Chair:

    

    Timothy W Hsu, MHSA
    International Expert on Health Industry | Vice President Industry & Emerging Technologies, UNIDO|AAMI

• 09:20 – 11:15

  Opening Plenary

  Ballraum 2&3

  • Moderator:

    

    Marilyn Romieux
    Strategy Director - Pharma segment, Merck KGaA

  This conference will show a larger picture of our industry’s raison d’être. Regardless of whether we work for a drug manufacturer, a materials supplier, a software developer, or a consulting firm; whether our roles lie in drug discovery, manufacturing, quality control, or IT; and whether we identify as scientists, engineers, IT specialists, or strategists, we all unite our efforts to enhance human health. At the end of the value chain stand patients in hope for advancements in their treatment. We want to highlight the impact our industry’s progress has on healing people. Innovations in digital technology, the implementation of automation and robotics, and the applications of artificial intelligence are making a real difference in people's lives. We will hear insights from organizations dedicated to health, extending beyond the pharmaceutical sector, to understand this impact further.

  • 09:20 – 09:45

    Beyond Safety, Efficacy, and Compliance: The Human Impact of Digital Innovation

    • Keynote Speaker:

      

      Stacey Tinianov, MPH
      Patient Advocate, Founder, Advocates for Collaborative Education

  • 09:45 – 10:10

    AI in Life Sciences: When Innovation Comes From the Unimaginable

    • Academic Presenter:

      

      Laura Adams, MS
      Senior Advisor, National Academy of Medicine

  • 10:10 – 10:35

    How is AI Implemented at Swissmedic

    • Regulatory Presenter:

      

      Nicolas Löffler-Perez, PhD
      Data Scientist, Swissmedic

  • 10:35 – 11:15

    Plenary Discussion

    • Moderator:

      

      Marilyn Romieux
      Strategy Director - Pharma segment, Merck KGaA

    • Panelist:

      

      Laura Adams, MS
      Senior Advisor, National Academy of Medicine

    • Regulatory Panelist:

      

      Nicolas Löffler-Perez, PhD
      Data Scientist, Swissmedic

    • Panelist:

      

      Stacey Tinianov, MPH
      Patient Advocate, Founder, Advocates for Collaborative Education

• 11:15 – 11:45

  Networking Coffee Break, Poster Session & Exhibition

  Topaz & Topaz Foyer

• 11:45 – 13:15

  Session 1: Understanding Artificial Intelligence

  Ballraum 2&3

  • Moderator:

    

    James R. Francum, MBA
    CEO, GxP-CC

  In this session, we will explore the necessary foundations for successfully adopting artificial intelligence, including management and quality of data, organizational competencies and skillsets, and clear and focused adoption strategies. High-quality data is an essential ingredient for AI to robustly produce unbiased and accurate predictions, reliable insights, and effective decision-making. Technology and business domain competencies are both equally essential to understand the strengths, weaknesses, and risks of various technologies and ensure these are well-matched to the business processes and the nuanced meanings of the data. Solid adoption strategies will ensure foundations are in place and investments are focused to match business priorities.

  • 11:45 – 12:05

    The Connections Between AI, Data Management, Data Integrity, and Knowledge Management

    • Presenter:

      

      James L Vesper, PhD, MPH
      Director, Learning Solutions, ValSource, Inc.

  • 12:05 – 12:25

    AI-Powered Data: Revolutionizing Real-Time Release and Quality by Design

    • Presenter:

      

      Fabrizio Maniglio
      Industry and Business Development Director, Honeywell

  • 12:25 – 12:45

    On Our Journey From MANUfacturing to SMARTfacturing | Miss the Shift - Miss the Future

    • Presenter:

      

      Michelangelo Canzoneri, PhD
      Global Head of Group Smart Manufacturing, Merck KGaA Darmstadt, Germany

  • 12:45 – 13:15

    Q&A, Discussion

    • Moderator:

      

      James R. Francum, MBA
      CEO, GxP-CC

    • Panelist:

      

      Michelangelo Canzoneri, PhD
      Global Head of Group Smart Manufacturing, Merck KGaA Darmstadt, Germany

    • Panelist:

      

      Fabrizio Maniglio
      Industry and Business Development Director, Honeywell

    • Panelist:

      

      James L Vesper, PhD, MPH
      Director, Learning Solutions, ValSource, Inc.

• 13:15 – 13:30

  LIVE Guided Poster Walk Engage with our Poster Presenters in our Exhibition Hall

  Topaz & Topaz Foyer

  • Moderator:

    

    Tom J.B de Man, MSc
    Head of Omics and Machine Learning R&D, Merck

  • 13:15 – 13:30

    AI and Automation in Microbiological Environmental Monitoring: Standardization, Savings and Other Benefits

    • Poster Presenter:

      

      Nicole Schepis
      

  • 13:15 – 13:30

    DIGITAL CPV - An Implementation Case Study

    • Poster Presenter:

      

      Maria Batalha, MSc
      Senior Consultant, ValGenesis

  • 13:15 – 13:30

    In-Silico Process Development and Scale-Up Simulations for the Manufacturing of a Late-Phase Vaccine Product

    • Poster Presenter:

      

      Antonio Castro, PhD
      Senior Scientist, Johnson & Johnson - Innovative Medicine

  • 13:15 – 13:30

    RAGulating Compliance: A Multi-Agent Knowledge Graph Approach for Regulatory QA

    • Poster Presenter:

      

      Alex Kaplunov
      

  • 13:15 – 13:30

    Traceability Solutions for Smart Manufacturing

    • Poster Presenter:

      

      Ali Badiei, MSc
      Head of Digital Supply Chain Solutions, Gerresheimer

  • 13:15 – 13:30

    Transform Your Inspection from Excellent to Genius

    • Poster Presenter:

      

      Christian Haenlein, M.Sc.
      Senior Product Owner, Körber Pharma Inspection

• 13:30 – 14:30

  Networking Lunch Break, Poster Session & Exhibition

  Topaz & Topaz Foyer

• 14:30 – 15:55

  Session 2: Speed Talks - Enabler for Manufacturing

  Ballraum 2&3

  • Moderator:

    

    Maria Batalha, MSc
    Senior Consultant, ValGenesis

  This dynamic session features concise and impactful "Speed Talks," providing attendees with rapid exposure to essential innovations and best practices shaping the future of pharmaceutical manufacturing. Expert speakers will present focused insights into advanced technologies and methods, including artificial intelligence for trend detection in quality processes, big data and IoT for predictive maintenance, comprehensive digitalization for environmental monitoring, and an overview of PDA Technical Report 22, which covers the latest guidance on equipment qualification and validation. Designed to facilitate quick learning and encourage active participation, this session delivers actionable knowledge and practical strategies that enhance operational efficiency, ensure compliance, and drive continuous improvement in manufacturing processes.

  • 14:30 – 14:45

    Interactive Questionnaire Session

    • Moderator:

      

      Maria Batalha, MSc
      Senior Consultant, ValGenesis

  • 14:45 – 14:55

    AI in Action: NLP & GenAI for Pharma Manufacturing

    • Presenter:

      

      Mehran Kamkarhaghighi, PhD
      Senior Data Scientist, F. Hoffmann-La Roche Ltd

  • 14:55 – 15:05

    From Downtime to Uptime: Predictive Maintenance for Operational Efficiency

    • Presenter:

      

      Joel Nuñez
      Product Manager / Marketing Manager, Syntegon Telstar

  • 15:05 – 15:15

    Leverage your QC Operational Efficiency Thanks to a Comprehensive Digitalization of your Environmental Monitoring Process to meet the High Standard of Compliance and Optimize Resource Allocation

    • Presenter:

      

      Florian Morillon
      Global solution manager, 3PEnterprise, bioMérieux

  • 15:15 – 15:25

    Updates on PDA Technical Report 22: Most Relevant Changes of the New Approved Version

    • Presenter:

      

      Patrizia Muscas, PhD
      Director Sterility Assurance , Global TS/MS (SAT), Eli Lilly and Company

  • 15:25 – 15:55

    Q&A, Discussion

    • Moderator:

      

      Maria Batalha, MSc
      Senior Consultant, ValGenesis

    • Panelist:

      

      Mehran Kamkarhaghighi, PhD
      Senior Data Scientist, F. Hoffmann-La Roche Ltd

    • Panelist:

      

      Florian Morillon
      Global solution manager, 3PEnterprise, bioMérieux

    • Panelist:

      

      Patrizia Muscas, PhD
      Director Sterility Assurance , Global TS/MS (SAT), Eli Lilly and Company

    • Panelist:

      

      Joel Nuñez
      Product Manager / Marketing Manager, Syntegon Telstar

• 15:55 – 16:25

  Networking Coffee Break, Poster Session & Exhibition

  Topaz & Topaz Foyer

• 16:25 – 17:40

  Session 3: Artificial Intelligence: From Validation to Compliance

  Ballraum 2&3

  • Moderator:

    

    Sesethu Dowiasch, MBA
    Life Science Industry Account Manager, Rockwell Automation

  This session explores the integration of AI and digital solutions in the pharmaceutical industry, focusing on validation and compliance strategies. Presentations will cover practical approaches to managing AI and automation within a cGMP framework, leveraging validation model tools. A case study from a pharmaceutical company will demonstrate how AI and digital technologies enhance process optimization and quality assurance, improving compliance and productivity. Attendees will gain insights into innovative validation strategies, regulatory compliance, and the transformative power of digital technologies in pharmaceutical manufacturing.

  • 16:25 – 16:40

    Embracing the Digital Revolution: A Strategic Framework for Transforming Pharmaceutical Manufacturing

    • Presenter:

      

      Scott Deckebach, MBA
      Senior Director, Data Integrity, Governance and Advanced Digital Compliance, Lachman Consultant Services, Inc.

  • 16:40 – 16:55

    The Integration of AI and GMP in the Pharmaceutical Industry: Advancements, Challenges, and Regulatory Perspectives

    • Presenter:

      

      Stefan Marc Pauli, PhD
      SME Data Science, VTU Engineering

  • 16:55 – 17:10

    Enhancing Pharmaceutical Manufacturing with AI - From Process Intelligence to Compliance

    • Co-Presenter:

      

      Davide Botta, BS Environmental Engineering
      Director, Site Lead, Recordati Ireland Ltd

    • Co-Presenter:

      

      Maria Zunica
      Head of Quality and Regulatory Affairs, Recordati Industria Chimica e Farmaceutica SpA

  • 17:10 – 17:40

    Q&A, Discussion

    • Moderator:

      

      Sesethu Dowiasch, MBA
      Life Science Industry Account Manager, Rockwell Automation

    • Panelist:

      

      Davide Botta, BS Environmental Engineering
      Director, Site Lead, Recordati Ireland Ltd

    • Panelist:

      

      Scott Deckebach, MBA
      Senior Director, Data Integrity, Governance and Advanced Digital Compliance, Lachman Consultant Services, Inc.

    • Panelist:

      

      Stefan Marc Pauli, PhD
      SME Data Science, VTU Engineering

    • Panelist:

      

      Maria Zunica
      Head of Quality and Regulatory Affairs, Recordati Industria Chimica e Farmaceutica SpA

• 17:40 – 21:30

  End of Conference Day 1 & Networking Event

  Ballraum 2&3

CEST Daylight Time (UTC +2:00)

• 08:00 – 08:45

  Update of the Interest Group Advanced Manufacturing and Applied Process Digitalization

  Ballraum 2&3

  • Moderator:

    

    Peter J Makowenskyj, MEng
    Senior Director of Design Consulting, G-CON

• 08:00 – 16:00

  Registration Open

  Topaz & Topaz Foyer

• 09:00 – 09:05

  Welcome Back by the Co-Chairs

  Ballraum 2&3

  • Co-Chair:

    

    Marilyn Romieux
    Strategy Director - Pharma segment, Merck KGaA

  • Co-Chair:

    

    Timothy W Hsu, MHSA
    International Expert on Health Industry | Vice President Industry & Emerging Technologies, UNIDO|AAMI

• 09:05 – 10:35

  Session 4: With an Eye Towards Digital Operations

  Ballraum 2&3

  • Moderator:

    

    Stephanie Knüppel, PhD
    Head Sterile Manufacturing & Packaging - E2E Value Stream Lead

  The pharmaceutical industry is undergoing a digital transformation, leveraging AI, machine learning, and automation to enhance manufacturing efficiency, quality, and compliance. This track explores cutting-edge advancements driving this shift, providing insights into AI and machine learning applications in pharmaceutical manufacturing, the role of operational data in accelerating in-silico process optimization across the product lifecycle, and the latest innovations in sterility testing automation with traceable robotics. These talks offer a forward-looking perspective on digital operations, equipping industry professionals with the knowledge to optimize processes and ensure regulatory alignment.

  • 09:05 – 09:25

    AI and Machine Learning in Pharmaceutical Manufacturing

    • Presenter:

      

      Mónica Perea-Vélez, MSc, PhD
      CMC Advocacy and Policy Director, GSK

  • 09:25 – 09:45

    Accelerating In-Silico Process Optimization Across the Product Lifecycle Fuelled by Operational Data

    • Co-Presenter:

      

      Fabian Feidl, PhD
      CTO and co-founder, DataHow AG

    • Co-Presenter:

      

      Sesethu Dowiasch, MBA
      Life Science Industry Account Manager, Rockwell Automation

  • 09:45 – 10:05

    TraceBot: Sterility Testing Automation With Traceable Robotics

    • Presenter:

      

      Patrick Courtney, MBA PhD
      Lecturer, King's College London

  • 10:05 – 10:35

    Q&A, Discussion

    • Moderator:

      

      Stephanie Knüppel, PhD
      Head Sterile Manufacturing & Packaging - E2E Value Stream Lead

    • Panelist:

      

      Patrick Courtney, MBA PhD
      Lecturer, King's College London

    • Panelist:

      

      Sesethu Dowiasch, MBA
      Life Science Industry Account Manager, Rockwell Automation

    • Panelist:

      

      Fabian Feidl, PhD
      CTO and co-founder, DataHow AG

    • Panelist:

      

      Mónica Perea-Vélez, MSc, PhD
      CMC Advocacy and Policy Director, GSK

• 10:35 – 11:05

  Networking Coffee Break, Poster Session & Exhibition

  Topaz & Topaz Foyer

• 11:05 – 12:15

  Session 5: Sustainability

  Ballraum 2&3

  • Moderator:

    

    Christian Haenlein, M.Sc.
    Senior Product Owner, Körber Pharma Inspection

  Join us for an insightful session on sustainability as we explore how AI can drive sustainable operations, while also learning from healthcare and how sustainable digitization is impacting it. Our speakers will share insights on balancing process improvement, both for regulatory compliance and cost savings in manufacturing, with sustainability practices and long-term benefits. This session is perfect for anyone passionate about leveraging technology for a greener, more efficient future.

  • 11:05 – 11:25

    AI: The Perfect Tool to Supervise 24x7 Sustainability Aspects in the Site

    • Presenter:

      

      Toni Manzano, PhD
      CSO and Compliance Officer, Aizon

  • 11:25 – 11:45

    The Next Generation of Healthcare: Expanding Access for All

    • Presenter:

      

      Daniel Guedelha
      Founder & CEO, Generation Health - GenH

  • 11:45 – 12:15

    Q&A, Discussion

    • Moderator:

      

      Christian Haenlein, M.Sc.
      Senior Product Owner, Körber Pharma Inspection

    • Panelist:

      

      Daniel Guedelha
      Founder & CEO, Generation Health - GenH

    • Panelist:

      

      Toni Manzano, PhD
      CSO and Compliance Officer, Aizon

• 12:15 – 13:15

  Networking Lunch Break, Poster Session & Exhibition

  Topaz & Topaz Foyer

• 13:15 – 14:15

  Closing Plenary Session Part I

  Ballraum 2&3

  • Regulatory Moderator:

    

    Timothy W Hsu, MHSA
    International Expert on Health Industry | Vice President Industry & Emerging Technologies, UNIDO|AAMI

  In an era where global health security relies on resilient and agile health product production, the UNIDO International Centre for Health Industry Readiness in Abu Dhabi is poised to become a key driver of regional and global preparedness for future pandemics and emergencies. This session will explore UNIDO’s strategic approach to digital transformation in health, emphasizing the Centre’s role in enhancing industrial readiness across the MENA region and beyond. Discussions will focus on how advanced manufacturing, digitalization, Fourth Industrial Revolution (4IR) technologies, regulatory harmonization, and technology transfer are shaping the future of regional health industry development. The Centre will serve as a collaborative platform for health regulators, pharmaceutical manufacturers, and global industry leaders, working to strengthen local and regional production capacities while ensuring sustainable, efficient, and high-quality healthcare solutions.

  • 13:15 – 13:35

    Regional Approach to Digital Transformation in Health

    • Regulatory Presenter:

      

      Nora Markova, DPhil, MBA
      International Expert on Health Industry, UNIDO

  • 13:35 – 14:15

    Plenary Discussion

    • Regulatory Moderator:

      

      Timothy W Hsu, MHSA
      International Expert on Health Industry | Vice President Industry & Emerging Technologies, UNIDO|AAMI

    • Panelist:

      

      Daniel Guedelha
      Founder & CEO, Generation Health - GenH

    • Regulatory Panelist:

      

      Nora Markova, DPhil, MBA
      International Expert on Health Industry, UNIDO

    • Panelist:

      

      Stacey Tinianov, MPH
      Patient Advocate, Founder, Advocates for Collaborative Education

    • Panelist:

      

      James L Vesper, PhD, MPH
      Director, Learning Solutions, ValSource, Inc.

• 14:15 – 14:45

  Networking Coffee Break, Poster Session & Exhibition

  Topaz & Topaz Foyer

• 14:45 – 14:50

  Passport Raffle Announcement

  Ballraum 2&3

  • Moderator:

    

    Melanie Decker
    Parenteral Drug Association

• 14:50 – 16:25

  Closing Plenary Session Part II

  Ballraum 2&3

  • Regulatory Moderator:

    

    Timothy W Hsu, MHSA
    International Expert on Health Industry | Vice President Industry & Emerging Technologies, UNIDO|AAMI

  • 14:50 – 16:25

    Interactive Round Table Session

    • Moderator:

      

      Timothy W Hsu, MHSA
      International Expert on Health Industry | Vice President Industry & Emerging Technologies, UNIDO|AAMI

    • Moderator:

      

      Marilyn Romieux
      Strategy Director - Pharma segment, Merck KGaA

  • 16:25 – 16:35

    Conference Summary from the Co-Chairs

    • Co-Chair:

      

      Marilyn Romieux
      Strategy Director - Pharma segment, Merck KGaA

    • Co-Chair:

      

      Timothy W Hsu, MHSA
      International Expert on Health Industry | Vice President Industry & Emerging Technologies, UNIDO|AAMI

• 16:35 – 16:40

  Closing Remarks & Farewell

  Ballraum 2&3

  • Committee Member:

    

    Falk Klar, PhD
    General Manager, Vice President Europe, Parenteral Drug Association

• 16:40 – 16:40

  End of Conference

Posters

• Nicole Schepis

• Maria Batalha, MSc, Senior Consultant, ValGenesis

• Antonio Castro, PhD, Senior Scientist, Johnson & Johnson - Innovative Medicine

• Alex Kaplunov

• Ali Badiei, MSc, Head of Digital Supply Chain Solutions, Gerresheimer

• Christian Haenlein, M.Sc., Senior Product Owner, Körber Pharma Inspection