Case studies
Bring a real-world challenge to the room.
We curate two anonymised cases each cohort and work them through together with peers and faculty. Submit yours when you reserve a seat.
I want to submit a case →18th & 19th June 2026 · Barcelona
A two-day intensive for senior professionals navigating GMP, supply continuity, and the post-reform European regulatory environment.
Get ticketsBinnion's Drug Production in Europe is a boutique programme for professionals shaping how medicines are manufactured and brought to market across the EU.
Module sessions — 18 June 2026
Case roundtables — 19 June 2026
Case studies
We curate two anonymised cases each cohort and work them through together with peers and faculty. Submit yours when you reserve a seat.
I want to submit a case →Bring your team
Group rates apply automatically and we run a dedicated debrief session for teams attending together — useful when the goal is to align on a shared operating standard back home.
See group rates →Why attend
How EMA, EDQM, and national competent authorities interact in practice — and what to do when their guidance does not align.
Concrete frameworks for APIs, finished dosage forms, and combination products, calibrated to what inspectors are flagging in 2026.
Walk away clear on what the new EU pharmaceutical legislation changes for your operations.
Maximum thirty senior attendees, all under Chatham House rule. The dinner conversations are usually the reason people come.
Faculty
Dr. Helena Roca
Director, Binnion Consulting
Twenty years in regulatory toxicology. Formerly with the EMA.
Dr. Marc Llobet
Senior Toxicology Lead, Binnion
Specialist in OEL/OEB determination and ICH M7 strategy.
Dr. Klaus Brenner
Independent GMP advisor
Former senior inspector with twelve years across EU manufacturing sites.
Dr. Nina Schäfer
Head of Quality, Adimera Therapeutics
Runs the PQS at a mid-size German CDMO. Frequent speaker on digital quality.
Caterina Russo, MSc
Supply Chain Director, Veridia Pharma
Built dual-sourcing strategy for a top-20 generic manufacturer.
Dr. James O’Connor
Partner, Penrose Pharma Strategy
Advised industry working groups on the 2024–2026 EU pharmaceutical reform.
Programme
A working map of EMA, the EU Commission, EDQM, and the network of national competent authorities.
Eudralex Volume 4 in practice. Where the bar moved through 2025 and the most common deficiencies in recent inspections.
Moving a process between EU sites, and between an EU sponsor and a non-EU CDMO. Documentation, validation, regulatory checkpoints.
PQS architecture, deviation handling, and digital quality tools without falling into validation traps.
Lessons from the 2022–2024 shortages, the Critical Medicines Act, and what dual-sourcing looks like operationally.
CSRD, CBAM, and the practical reporting obligations now landing on pharma manufacturers.
Regulatory data protection, generic and biosimilar entry, environmental risk assessment — translated into operational consequences.
Two anonymised case studies brought by participants, worked through together. Submit yours during registration.
Who should attend
Schedule
Day 1 · Thursday 18 June
Foundations
Day 2 · Friday 19 June
Practice
Venue
AddressCasa Llotja de Mar
Passeig d'Isabel II, 1, 08003 Barcelona
Closest stationsBarceloneta (L4), Jaume I (L4)
AccessibilityThe venue provides step-free access. Let us know in advance if you need additional assistance.
FAQ
Senior professionals working in pharmaceutical manufacturing, regulatory affairs, quality assurance, supply chain, or commercial operations who need a working understanding of how drug production functions across the European Union. Most attendees come with five or more years of industry experience.
A baseline familiarity with pharma operations is helpful but not required. The programme brings commercial and operational profiles up to speed alongside scientific ones.
Sessions are not recorded. The programme runs under Chatham House rule, which we have found makes for a more candid exchange among peers.
Course materials, two lunches, the networking dinner on day one, and the certificate of attendance. Travel and accommodation are not included.
Yes. Once your seat is confirmed, we issue a pro forma invoice with thirty-day payment terms. VAT is added where applicable.
Full refund up to thirty days before the course start. Fifty per cent refund up to fourteen days before. After that, seats are transferable to a colleague at no charge.
Enter your details and we will send you a secure link to confirm. Seats are released in order of confirmation; the cohort caps at thirty.