Annual Extractables and Leachables Summit

October 2017



Maritim Hotel Berlin

Stauffenbergstraße 26, 10785

About Summit

This premier event provides the appropriate platform to discuss and network with peers involved in pharmaceutical manufacturing, toxicology, quality control, devices, single-use systems, equipment and container development. The summit will shed light on guideline updates, analytical testing innovations, and the impact of E&L on biologics safety. It is an honour and privilege to invite you to participate in this Summit. We look forward to welcoming you at the Summit in Berlin this coming October!

Who Should Attend

Chief Executives, Directors, Vice Presidents, Department Heads, Leaders, Senior Managers, Scientists, Chemists, Engineers and Fellows specialising in:

  • Bioprocessing
  • CMC
  • Extractables and Leachables/ E&L
  • Licensing
  • Materials Selection
  • Medical Devices
  • Packaging and labelling
  • Pharmaceutical Analysis
  • Risk management
  • Safety Assessments
  • Standardisation
  • Toxicology
  • Container development
  • Device Engineering
  • Formulation
  • Materials Science
  • Manufacturing Science and Technology
  • Parenterals
  • Product and Process Development
  • QA/QC
  • Regulatory Affairs
  • Scientific Affairs
  • Testing
  • Validation
Key Practical Learning Points of the Summit

Regulatory considerations and working group updates
Single Extractable standard (BPOG, USP and ASTM)
Standards and validation
Innovations in analytical techniques
E&L in quality control
Extractables and Leachables considerations for single-use systems
Pharmaceutical materials characterisation
Toxicological evaluation of Leachables
Regulatory requirements and expectations
Ken Wong, USA

Deputy Director

Sanofi Pasteur

Carsten Worsøe, DE

Principal Scientist

Novo Nordisk A/S

Dr. Simone Biel, DE

Field Marketing Single Use Technology | EU Process Solutions

Merck Chemicals GmbH

Dr. Michael Jahn, CH

Group Head Forensic Chemistry


Dr. Reinhard Stidl, AT

Lead Toxicological Risk Assessments


Dr. Lothar Habel, BE

Study Director

Toxikon Europe

Dr. Tino Otte, CH

Senior Scientific Consultant


Irene Cecchini, DE

Laboratory Manager

Merck KGaA

Dr. Armin Hauk, DE

Lead Scientist Extractables & Leachables

Sartorius Stedim Biotech GmbH

Pete Watts, UK

Director of Toxicology

Bibra Toxicology Advice & Consulting

Bram Jongen, BE

Head of Material Development, Container Closures & Injection Systems

DATWYLER Sealing Solutions

Mike Ludlow, UK

Technical Study Manager Drug Development Services


Francois Bianchi, FR

Head of Global Packaging Migration Mgmt

B. Braun Medical AG

Dr. Andreas Nixdorf, DE

Business Development Manager Extractables & Leachables Testing

SGS Life Science

Dr. Tom van Wijk, NL

Senior Scientist

Analytical Science &Technology Abbott Healthcare Products B.V.

Sponsors and Partners




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