TRAINING COURSE

 WED 09.09.2026 & THU 10.09.2026

Leuven, Belgium

THIS TRAINING COURSE  IN A NUT SHELL

  • Regulatory framework on Plastic Materials of Construction
  • Polymer Additives and their Behavior
  • What can you expect from Raw Material Suppliers?
  • Extractables Testing: Basic principles and regulations
  • Principles of Validation in ​Extractables & Leachables Studies
  • Toxicological Assessment based on the E&L data and the application(s)
  • E&L as part of Incoming Inspection
  • The impact of Sterilization Technologies on E&L Data
  • Regulatory Developments in Sterilization
  • Principles for VHP (VH2O2) Industrial Sterilization and Validation for Pharmaceutical Product Applications
  • Emerging contaminants of toxicological concern: N-nitrosamines.

TARGET AUDIENCE

  • Consultants and Industry Experts in the field of pharmaceutical packaging and drug product manufacturing
  • Polymer manufacturers
  • Container closure manufacturers
  • Pharmaceutical  and medical device compagnies
  • Toxicologists
  • Regulatory Affairs
  • Quality Control / Quality Assurance
  • R&D Scientists within Pharma (packaging)
  • Testing Laboratories active in the pharmaceutical business and Medical Device industry

SCHEDULE

The event will start on Wednesday at 
10:30 AM and will conclude on Thursday around 13:00 PM, followed by a closing lunch (included).
A more detailed schedule will be shared soon.

Register Contact

PRACTICAL INFORMATION

Location: Leuven, Belgium. 
Leuven is just 15 minutes by train from Brussels Airport and 30 minutes from Brussels South Station, where high-speed trains connect to Paris, London, Amsterdam, Vienna, and many other destinations. Leuven is a vibrant city known for its beer culture, historic sites, and strong focus on education, research, and innovation.

Dates: Wednesday 9 – Thursday 10 September 2026
The event begins on Wednesday at 10:30 AM.
It concludes on Thursday around 13:00 PM, followed by a closing lunch (included).

Evening Program
A networking event and dinner will take place on Wednesday evening, 9 September. This is included in the registration fee.

Accommodation & Meeting Venue
The event will be held at the Park Inn hotel (Radisson) Leuven, at walking distance from the railway station.
After registration, all attendees will receive a dedicated booking link. You can use this link if you wish to stay at the venue. Please note that accommodation is not included and must be arranged individually.

Registration fee 
The registration fee is 580 EUR (excl. VAT). This includes:
  - Lunch on Wednesday and Thursday
  - Participation in the networking event and dinner on Wednesday evening

Early Bird Fee: payments received prior to 10 August 2026 are eligible for the early bird fee:
     490 EUR (excl. VAT)

WHY THIS COURSE IS DyFrND

This training course takes a DyFrNd approach towards plastics used for pharmaceutical packaging. Instead of focusing on just one specific aspect, it offers broad insights into multiple important topics, delivered by seasoned industry experts with real-world experience. 

Join us to gain valuable regulatory context, learn from practical case studies, and benefit from shared insights built on decades of cross-functional expertise. Dedicated Q&A sessions will allow you to ask tailored questions relevant to your own challenges. 

Due to parallel approaches and common materials of construction, this Training Course is also relevant and valuable for professionals working in the field of Chemical Characterization of Medical Devices per ISO10993-18.

MEET THE HOST & SPEAKERS

FRANK DE SMEDT

DyFrNd - founder

  • Regulatory Framework on Plastic Materials of Construction
  • Polymer Additives and their Behavior
  • Extractables Testing: Basic Principles and regulations
  • The Impact of Sterilization Technologies on E&L Data

HORST KOLLER

Inductie AG - Chief Quality & Regulatory Officer

  • What can you expect from Raw Material Suppliers?
  • Extractables and Leachables as part of Incoming Inspection

JUHA MATTILA

STERIS - Senior Manager Technical Services

  • Regulatory Developments in Sterilization
  • Principles for VHP (VH2O2) Industrial Sterilization and Validation for Pharmaceutical Product Applications

BRIAN SCHÜTTRUMPF

SGS IF - Subject Matter Expert E&L Pharma

  • Principles of Validation in Extractable & Leachables Studies 
  • Emerging contaminants of toxicological concern: N-nitrosamines

FRANK DE SMEDT

DyFrNd - Founder

Voorbeeldtekst. Klik om het tekstelement te selecteren.

Regulatory Framework on Plastic Materials for Pharmaceutical Applications
Polymer additives and their behavior
Extractables & Leachables Testing
The impact of Sterilization Technologies on E&L Data 

HORST KOLLER

Inductio AG - ISO Committee TC76 & TC84 Industry Expert

Voorbeeldtekst. Klik om het tekstelement te selecteren.

What can you expect from Raw Material Suppliers?
Extractables & Leachables as part of incoming inspection