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9th HPAPI: Development and Manufacturing of Highly Potent Active Pharmaceutical Ingredients (APIs)
Early bird price

9th HPAPI: Development and Manufacturing of Highly Potent Active Pharmaceutical Ingredients (APIs)

Discover the future of high-potency pharma at the 9th HPAPI Summit 2026—where innovation, containment, and compliance shape tomorrow’s therapies.

calendar_month
Date16th – 17th Sep 2026
map
PlaceMilan, Italy
Price
from€1 199€1 799
calendar_month
Date16th – 17th Sep 2026
map
PlaceMilan, Italy

Program-at-a-Glance 

 

DAY 1 — High-Potency Development, Containment & Risk Mitigation

  • HPAPI Development & CMC Foundations
  • Containment, Cleaning & Occupational Safety
  • Material Handling, Equipment & Facility Design
  • Outsourcing, CDMO Collaboration & Tech Transfer

Panel Discussion  & Business Dinner

DAY 2 — Process Development, Analytical, Quality & GMP Operations

  • Process Development for Highly Potent Compounds
  • Analytical, Quality, and Regulatory Standards
  • Automation, Digitalization & Future Technologies

Panel Discussion  & Business Lunch

Speakers

Dr. Ulrich Rümenapp, DE
Dr. Ulrich Rümenapp, DESenior Biotech Program Lead
James L. Drinkwater, DE
James L. Drinkwater, DEHead of GMP Compliance & Honorary member PHSSFranz Ziel GmbH
Christa Myers, US
Christa Myers, USSr. Fellow - Aseptic and Sterile ProductsCRB
Justin Mason-Home, UK
Justin Mason-Home, UKOwner/DirectorHPAPI Project Services Limited
Dr. Andreas Schreiner, CH
Dr. Andreas Schreiner, CHGlobal Validation Network Leader, Validation LeadNovartis

Key points

  • Risk & Hazard Analysis – Learn how to identify HPAPI hazards, toxicity, and exposure risks to build strong containment strategies.

  • Containment Advances – Explore the latest isolator designs, engineering controls, and tech solutions that protect workers and ensure product integrity.

  • PPE Mastery – Best practices for selecting, training, and using PPE tailored for high-potency environments.

  • OEL Compliance – Setting, maintaining, and monitoring strict occupational exposure limits to safeguard teams and meet regulations.

  • Facility Design & Optimization – Insights on layout, airflow, and modular upgrades to enhance safety and efficiency in HPAPI production.

  • Cleaning & Decontamination – Validated cleaning protocols and decon methods to eliminate HPAPI residues.

  • Training & Safety Culture – Building a proactive culture with targeted training on handling, risk reduction, and incident management.

  • Waste & Environmental Management – Effective disposal and containment practices to minimize environmental footprint.

  • Supply Chain Security – Ensuring compliant storage and transport of HPAPIs across the global supply chain.

  • Global Regulatory Alignment – Staying ahead of FDA, EMA, and worldwide requirements for HPAPI handling and compliance.

Who should attend

Chief Executives, Vice Presidents, Directors, Heads, Leaders, and Managers specializing in:

  • Manufacturing & Processing
  • Quality & Compliance
  • Health & Safety
  • Research & Development
  • Business Strategy & Commercialization
  • Industry Sectors
  • Facility & Equipment Management
  • Operational & Plant Management
  • Product & Process Quality
  • Additional Key Areas

Sponsors

Bausch+Ströbel

9th HPAPI: Development and Manufacturing of Highly Potent Active Pharmaceutical Ingredients (APIs)

Discover the future of high-potency pharma at the 9th HPAPI Summit 2026—where innovation, containment, and compliance shape tomorrow’s therapies.

calendar_month
Date16th – 17th Sep 2026
map
PlaceMilan, Italy
Price
from€1 199€1 799

Industry about us

Christa from null
ChristaInvested Business Leader: Global Aseptic & Sterile Products Vertical Market Leader at CRB

It was a great conference with deep content and even deeper conversations. I love seeing an industry coming together to deep think solutions and plan for the future.

FAQ

Your questions answered here.

Are there networking opportunities?

Both in-person and online attendees can participate in numerous networking sessions, panel discussions, and Q&A sessions with industry experts. An event app will also be available, allowing delegates to arrange meetings and calls with other attendees, whether they are joining virtually or in person.

What delegate (attendee) packages do you offer?

We offer tailored packages based on participant profiles, including options for pharma and biotech companies, solution providers, startups, and academic institutions.

For added flexibility, we also provide virtual attendance and documentation-only packages for selected events.

You can find full details, pricing, and what's included on each event’s dedicated page.

A 10% discount is available for group registrations — contact us for more information.

What’s included in the registration fee?

Registration includes access to all sessions for 2 conference days, official event materials, scheduled networking activities, and catering during the event (coffee breaks and lunches both days) and networking dinner on the 1st conference day to polish your new connections.

Accommodation and travel costs are not included.

Will I receive presentation slides after the event?

Yes — all registered participants receive access to post-event materials, including authorized speaker presentations (subject to permission), and other relevant documents.

If you’re unable to attend in person, a documentation package can be purchased separately. For selected hybrid events, we also offer a recording package with on-demand access to sessions.

What language will the summit be conducted in?

All summit sessions will be presented in English. While translation services are not provided, we welcome attendees from around the world and encourage everyone to join the discussions and networking opportunities.

How can I register for an event?

You can register online via each event’s dedicated page. Once submitted, you’ll receive a confirmation and invoice by email. For special requests, feel free to contact our team directly to hello@etapahub.com or the contact person noted at the designated event page.

How can I get more information?

We’d love to help you make the most of the summit! You can request the summit brochure or contact our team directly using the details below. Our team is happy to answer any questions and guide you in planning your participation.

For any event assistance please contact

Irina Andres
Irina AndresSales and Booking Specialist
mailirina@etapahub.com