Nordic Affiliate Pharma 4.0 Community of Practice

 

Who we are

The ISPE Nordic Pharma 4.0 CoP is a technical community and acts as a regional innovation and adoption hub, applying the global Pharma 4.0™ framework and Plug & Produce (Plug and Produce Working Group) concepts within the Nordic pharmaceutical ecosystem.

To ensure consistency and regulatory credibility worldwide, it follows the strategic direction of ISPE Pharma 4.0™ initiative.

Mission

The ISPE Nordic Pharma 4.0 CoP aims to accelerate digital transformation in the Nordic pharmaceutical industry by fostering collaboration and knowledge sharing around Pharma 4.0™ principles. Its mission is to translate global Pharma 4.0™ frameworks into practical, compliant, and regionally relevant approaches by connecting industry, technology partners, and regulators. Through dialogue, pilots, and best-practice exchange, it supports a patient-centric, data-driven, and future-ready pharmaceutical ecosystem in the Nordics. 

Goals

  • Driving CoP activities, meetings, events around Pharma 4.0 Plug & Produce (P&P) and other digital initiatives. 
  • Technological Deep Dive for Plug & Produce with focus on Modular Production / Automation. 
  • Establishing / using established connections with the international ISPE CoPs and other organizations like IDA, VDI, VDE, PNO, BioPhorum, NAMUR, Plattform Industrie 4.0. 

Focus topics 

The ISPE Nordic Pharma 4.0 CoP is focusing on topics to drive modular, interoperable manufacturing and support plug-and-produce concepts, advancing digital transformation in Nordic pharma:  

  • MTP (Module Type Package) 
  • Intrinsic Quality & Compliance 
  • More to come :)
Matthias Barbian
Manager for Engineering and Manufacturing Enabled by AI
Accenture
Chair
Tatiane Hedegaard
Director QA Commercial
Genmab
Vice Chair
Nordic Pharma 4.0 Committee Core Team
Kasper Berendt
Manager
Fujifilm Biotechnologies Denmark
Vice Roncevic
Founder & CEO
Calibras ApS
Anna Bengtsson
Application Engineer
Beckhoff Automation
Honorata Witkowska
Supply Planner
ISPE NORDIC
 
Plug and Produce, MTP (Module Type Package)
Matthias Barbian
Manager for Engineering and Manufacturing Enabled by AI
Accenture
Thomas Makait
Managing Director
MTP4Pharma® - Plug & Produce for Smart Manufacturing - Intrinsic Quality & Compliance
Sebastian Härtner
Principal Project Lead
Merck KGaA
 
AI – Industrial, Agentic and Physical – in GxP
Matthias Barbian
Manager for Engineering and Manufacturing Enabled by AI
Accenture
Vice Roncevic
Founder & CEO
Calibras ApS
Christian Hyltoft
Founder
Comeply
Automation for Pharma Manufacturing
Maria Grahm
Global Vice President, Life Sciences
Siemens
Mads Jacob Dømgaard--
Senior Automation Engineer
EngineerIT
Anna Bengtsson
Application Engineer
Beckhoff Automation
Nordic Pharma 4.0 Committee Capabilities
Agathe Lemaitre
Senior Leader
Novo Nordisk
Clara Kouakou
Validation Engineer
 
Pharma 4.0 Webinars
Michael Gohla
Strategic Account Manager Life Sciences
Endress+Hauser

Coming Events

  • MTP Nordic Summit 2027 (date tba)

Past Events

How to join us? 

Contact Matthias Barbian or Tatiane Ferreira Hedegaard via e-mail.

matthias.barbian@accenture.com    

tatian_ferreira@hotmail.com  

How to join ISPE?