ISPE Europe Annual Conference Kopenhagen 20. – 22. April 2026
DIGITAL TRANSFORMATION AND PHARMA 4.0
A silo mentality still prevails in many companies. But there is a growing awareness that open data ecosystems are crucial for competitiveness.
The transformation from a silo mentality to open data ecosystems is not just a buzzword for European industry, but a necessity to ensure competitiveness and digital sovereignty.
Experts see this development as the basis for future growth and the use of artificial intelligence (AI), but emphasize the urgency of implementation and the need for far-reaching cultural and organizational changes.
Cultural challenges: Many companies come from a culture of incremental improvement and efficiency. There is no real culture of innovation. Moreover, organizational and business models are often not yet network-compatible. This means that there is no connection to ecosystems.
New employees need to be trained more in systems thinking, because it’s about more than just interfaces and protocols. The joint business model must also be clear in order to anchor organizational and eco-systematic principles across company boundaries, for example with suppliers and authorities.
The holistic approach of ISPE Pharma 4.0 helps to provide orientation on how to prepare for a successful digital transformation in order to exploit the great potential for risk reduction, cost reduction and time savings.
REFORM OF EU LEGISLATION FOR PHARMA
The European Commission, the European Parliament and the Council of the European Union have reached a landmark political agreement on a comprehensive reform of EU pharmaceutical legislation. This is the most significant revision of the regulatory framework in over two decades and a unique opportunity to fundamentally change pharmaceutical regulation in the EU.
Important key elements for technical operation:
- More support and improved framework conditions for innovation
- Stronger protection against drug shortages: The reform introduces new rules for cooperation between marketing authorization holders and health authorities to ensure the security of supply and availability of critical medicines in the EU.
- Improved environmental protection
What does this mean for the pharmaceutical industry and for technical operations in particular? Come along and learn the regulators’ point of view, the perspective of industry peers and the opportunities for dialog between industry and regulators.
THE AGENDA
- Plenary presentations by EMA and national authorities
- Tracks on digital compliance, Pharma 4.0, GMP-compliant technology projects, news from the EU Commission’s Pharma Package
- Interactive workshops on drug shortages – what do the authorities require for prevention, new principles of quality risk management, digital transformation with practical examples, sustainability in light of the new EU rules, GMP-compliant projects – safe planning
- Panel discussion in plenary between industry and authorities – how will cooperation work with the new rules and in the digital age? How is AI being used?
SUCCESSFUL IMPLEMENTATION OF CURRENT REGULATIONS
Regulatory requirements are constantly evolving, are you ready to successfully implement these changes in your business?
Take the opportunity to gain valuable insights and learn about practical solutions and register now for the ISPE Europe Annual Conference.
