Conference Overview

Get the latest updates in regulation, analytical testing, risk & safety assessment, biocompatibility.

The featured talks on:

Using expert knowledge and machine learning to assess the mutagenicity and sensitisation potential of extractables and leachables
Applications of computational methods in the assessment of extractables and leachables
How to Improve the Accuracy of your E&L Testing
Toxicological Risk Assessment on Extractables and Leachables
How to Write a Toxicological Risk Assessment to Support Extractables and/or Leachables: A Step-by-Step Process
Duration-Based Non-Mutagenic Thresholds of Toxicological Concern (TTC) for Parenteral Extractables and Leachable
Health risk assessment of Extractables and Leachables – things are not always what they seem
Case sharing of chemical characterization applications during the whole life cycle of Medical Devices
Leveraging Analytical Chemistry Data of Medical Devices to Derisk Drug Combination Product Submission
Composition and shelf life considerations for the extractables profile of rubber
ISO 10993-17 update

Who You Will Meet

By Positions

C-Level, Presidents, Chairs, Members of the Board & VPs
Vice presidents, Directors, & Heads
Leaders & Managers
Principals, Engineers, Analysts & Scientists
Instructors & Trainers & Teachers
Advisors, Coordinators, Auditors & Consultants
Other Professionals, Experts & Specialists

By Divisions

Analytical Chemistry
Bioprocessing
Bioproduction
CCIT
CMC
Container Development
Device Engineering
E&L
Formulation
Glass
Manufacturing Science & Technology
Materials Science & Selection
Medical Devices
Packaging & Labelling
Parenterals
PFS
Polymers
Product & Process Development
QA/QC
Quality Testing
R&D
Regulatory Affairs
Risk Management & Assessment
Rubber
Safety Assessments
Scientific Affairs
Single Use Systems
Standardisation
Toxicology
Validation
Other

By Industries

Pharmaceutical
Biotechnology
Chemical
Medical Devices
Plastics
CMOs/CDMOs
CROs
NOPs
Regulatory Agencies
Training providers
Other

By Region

Central and Eastern Europe
North America
Middle East and Africa
Asia-Pacific
Other

Conference Programme

Day One - Tuesday 13, June 2023

Tentative Schedule:

Central European Summer Time (CEST, Prague, UTC/GMT +2 hour)

11:00

12:00

12:10 To Be Announced

Dr. Tino Otte,
Senior Scientific Consultant, Intertek (Schweiz) AG, Basel-Landschaft, Switzerland

12:50 To Be Announced

Andrew Feilden,
Director Analytical Sciences, Bicycle Therapeutics, Shawbury, United Kingdom

13:30

13:50 To Be Announced

Lukas Mogler,
Principal Scientist / Sr Group Leader, Lonza, CH

14:30 To Be Announced

Alicja Sobantka PhD,
Corporate Material Qualification – Manufacturing Science & Technology, Octapharma, Vienna, Austria

15:10 To Be Announced

Diego Zurbriggen,
Technical Account Manager, West Pharmaceutical Services, Inc., USA

15:50

16:10 To Be Announced

Samuel N Kikandi, PhD,
Deputy Director-Principal Engineer/ Material Science & E&L SME, Sanofi, USA

16:50 Using expert knowledge and machine learning to assess the mutagenicity and sensitisation potential of extractables and leachables

Dr. Charles Modlin, Ph.D.,
Application Scientist, Lhasa Limited, USA

17:30 Applications of computational methods in the assessment of extractables and leachables

Use of in silico approaches supporting the assessment of Extractables and Leachables (E&L)
Prevalence of predicted mutagens and potent sensitizers in large representative databases of E&L
Use of in silico models to assess leachable reactivity with biomolecules
Biomolecule reactivity in silico workflow

Dr. Candice Johnson,
Senior Research Scientist, Instem, Ohio, United States

18:10

Day Two - Wednesday 14, June 2023

Tentative Schedule:

Central European Summer Time (CEST, Prague, UTC/GMT +2 hour)

12:00

12:10 How to Improve the Accuracy of your E&L Testing

ISO/IEC 17025 requirements, traceability and uncertainty
Certification of relevant reference standards
Intended use of CRMs, applications, and use cases
Proficiency testing to improve your laboratory performance
Compound databases for screening

Markus Obkircher,
Director R&D, Head of Reference Materials and Proficiency Testing, Merck, Sankt Gallen, Switzerland

12:50 To Be Announced

Jason Creasey,
Managing Director, Maven E&L Ltd, Stevenage, United Kingdom

13:30

13:50 To Be Announced

Erika Udovic,
Principal Scientist II, PCS Impurity Safety, Novartis, CH

14:30 To Be Announced

Atish Sen,
Director, Analytical Sciences Inhalation Product Development, AstraZeneca, North Carolina, United States

15:10 Toxicological Risk Assessment on Extractables and Leachables

Introduction: why do we need to care about E&L?
In silico assessment using computer expert systems
Concept of Threshold of Toxicological Concern
Concept of Permitted Daily Exposure
Compounds of specific concern: nitrosamines

Dr. Clemens Günther,
Director Nonclinical Safety Consumer Care, Bayer AG, Berlin, Germany

15:50

16:10 How to Write a Toxicological Risk Assessment to Support Extractables and/or Leachables: A Step-by- Step Process

Analytical identification of E&L compounds (tentative, definitive and unknowns)
No toxicity data exists for your E&L compound: What to do?
The E&L toxicology risk assessment process
Derivation of maximum daily exposure (MDE) values
Regulatory guidance as references for PDE values
Toxicology databases to obtain toxicity data
Selection of the point of departure to derive the PDE value

Dr. Greg Erexson, PhD, DABT, FATS, FRSB, ERT
AbbVie Retiree, Greg Erexson Toxicology Consulting, LLC, USA

16:50 Duration-Based Non-Mutagenic Thresholds of Toxicological Concern (TTC) for Parenteral Extractables and Leachable

Melisa Masuda-Herrera,
Senior Associate Scientist, Gilead Sciences, USA

17:30 PANEL DISCUSSION

Bram Jongen,
Vice President Materials & Surface Technologie, Datwyler Pharma Packaging International NV, Limburg, Belgium

Steve Zdravkovic,
Research Scientist II, Baxter International Inc., USA

18:10

Day Three - Thursday 15, June 2023

Tentative Schedule:

Central European Time (CET, Prague, UTC/GMT +2 hour)

12:00

12:10 Health risk assessment of Extractables and Leachables – things are not always what they seem

Chris Waine,
Senior Toxicologist, bibra toxicology advice and consulting, UK

12:50 Case sharing of chemical characterization applications during the whole life cycle of Medical Devices

Brief introduction to the application of chemical characterization
Chemical characterization application for material selection
Chemical characterization application for PCRB
Chemical characterization application for NMPA registration

Wenjing Zhao ,
Sr Scientist, Medtronic Technology Center – Greater China, Shanghai, China

13:30

13:50 Leveraging Analytical Chemistry Data of Medical Devices to Derisk Drug Combination Product Submission

Normative landscape around drug delivery systems development
Challenges for defining the appropriate study design for upcoming of complex, highly sophisticated wearable systems
Strategy proposal around potential standardization of test protocols in the context of Drug Combination Products

Delphine Brissaud,
R&D Staff Scientist, BD, FR

14:30 To Be Announced

Dr. Roberto Menzel,
Laboratory Supervisor and Manager Extractables, Sartorius Stedim Biotech, Göttingen, Germany

15:10 To Be Announced

Dr. Andreas Nixdorf,
Life Sciences - Business Development Manager Extractables & Leachables Testing, SGS Institut Fresenius GmbH, Frankfurt Am Main Area, Germany

15:50

16:10 Composition and shelf life considerations for the extractables profile of rubber

Dr. Tine Hardeman,
Manager Material Development Healthcare, Datwyler, Belgium

16:50 To Be Announced

Dennis Jenke,
Chief Executive Scientist, Triad Scientific Solutions, LLC, USA

17:30 ISO 10993-17 update.

Ron Brown
Owner and Principal Toxicologist, Risk Science Consortium, LLC, USA

18:10

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Online GROUP 4+

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Session: 40 minutes

OR Workshop: 60 minutes

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2-Days Summit

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