PharmaCongress 2026 – a full success

Apr 14, 2026 | 2 min read

Europe’s largest congress for the pharmaceutical industry on March 24-25, 2026, again showed just how important Annex 1 is, and will remain over the coming years. We have compiled some key learnings and insights for you.

Key takeaways
              Although Annex 1 has been in force since 2023, interest, uncertainty, and implementation challenges across the industry remain high. Many manufacturers are still far from fully compliant.
The demand for practical technical solutions continues to grow. Companies are actively looking for solutions that reduce risk, increase automation, and make processes more robust and reliable to close existing compliance gaps.
PharmaCongress confirmed that Syntegon is well positioned to support customers with its integrated portfolio, expertise in aseptic processing, barrier systems, automation, and regulatory guidance.

            

Back from the PharmaCongress in Wiesbaden, Germany, our experts Jean-Pierre Sedita and Anna Waldraff are happy to share their impressions, key learnings, and market insights. In a nutshell, everything evolved around EU GMP Annex 1, which has also been a strong focus for us and our partners long before it came into force.

Learn more

Annex 1 challenges, and no end in sight

Although Annex 1 was already published in August 2022, discussions and presentations at this year’s PharmaCongress showed that it is still top of the agenda for many – if not all – pharmaceutical and biotech manufacturers as well as CDMOs. The interest in the topic, but also the uncertainty regarding specific requirements and the challenges they pose on implementation remain high across the industry.

“Many manufacturers are still far from feeling ‘Annex 1 ready’, while compliance gaps persist and interpretations through inspection authorities remain inconsistent.”

Jean-Pierre Sedita, Head of Business Development Annex 1 EMEA at Syntegon

Co-creating Annex 1 compliance

Companies from the pharmaceutical industry are actively seeking partners who can translate regulatory expectations into practical, robust manufacturing strategies. The demand for technical solutions that enhance risk mitigation, automation, and process reliability continues to rise as organizations strive to close their Annex‑1‑related gaps. This is where our co-creation approach comes into play, which was underlined at PharmaCongress by the joint presentation of Syntegon and Sanofi on the topic of automated microbiological monitoring.

Together with our partners, we develop the matching solution for their Annex 1 challenges. Take Versynta microBatch or SynTiso as examples: both solutions were developed together with partners from the pharmaceutical industry and are now market-ready for everyone involved in aseptic liquid filling to reap the benefits of these joint developments. Moreover, our experts support you in retrofitting existing equipment. Together with your team, they conduct an analysis and develop an action plan, which is implemented with concrete solutions in the next step.

"As a long‑term strategic partner to the pharma and biopharma industry, we support our customers in navigating all Annex 1 requirements by combining regulatory expertise with practical, system‑focused implementation."

Anna Waldraff Product Manager Annex 1 at Syntegon

Let’s talk about Annex 1

PharmaCongress clearly confirmed that we are on the right track: Our customers rely on our technologies and services to address their critical needs for Annex‑1‑compliant processes and future‑proof production environments. With our integrated portfolio and strong expertise in aseptic processing, barrier systems, and automation, we are uniquely positioned as a trusted solutions and systems partner for Annex 1 compliance.

No matter where you are on your journey towards Annex 1 compliance, Syntegon is your partner throughout the entire machine lifecycle. Get in touch with us; we look forward to working with you on joint projects.