4th Annual Impurities: Genotoxic and Beyond Summit

September 2020



Eurostars Roma Aeterna

Via Casilina 125, 00176


This premier B2B event provides the appropriate platform to engage and discuss ideas with your peers, while facilitating a professional atmosphere and environment for good company representation and development. The Summit will shed light on the compliant implementation practice of ICH M7 and Q3D and novel strategies for efficient mutagenic and elemental impurities identification and control. It is an honour and privilege to invite you to participate in this Summit. We look forward to welcoming you in September!

Who Should Attend

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

  • ADC (Antibody Drug Conjugates)
  • API Development
  • Biotherapeutics
  • Carcinogens
  • Chromatography
  • DNA Reactive Impurities
  • Drug Design
  • Drug Discovery
  • Drug Substance
  • Extractables & Leachables
  • Genetic Toxicology
  • Genotoxicity
  • GMP
  • GRAs
  • Impurities
  • Large Molecule
  • Mass Spectrometry
  • Mutagenic Impurities
  • Nanomaterials
  • New Modality
  • Organic Synthesis
  • Peptide
  • Pre-Clinical Drug Safety
  • Process-Related Impurities
  • Protein
  • Purge Factors
  • Quality by Design (QbD)
  • Regulatory
  • Safety Assessment
  • Spectroscopy
  • Technology Transfer
  • Toxicology
  • Analytical Science
  • Assay Development
  • Carcinogenic Impurities
  • Chemistry (Analytical, Organic, Medicinal, Protein)
  • Degradation Products
  • DNA Reactivity
  • Drug Development
  • Drug Safety
  • Elemental Impurities
  • Formulation
  • Genotoxic Impurities
  • Genotoxin
  • Good Laboratory Practice
  • GTIs
  • In Silico
  • LC-MS
  • Microscopy
  • Mutagenicity
  • Nanoparticles
  • Oligonucleotide
  • Particles
  • PGTIs
  • Process Chemistry
  • Product-Related Impurities
  • Purification
  • Quality Assurance
  • Quality Control
  • Research and Development
  • Small Molecule
  • TDI
  • Threshold of Toxicological Concern (TTC)
  • Validation
Key Practical Learning Points of the Summit

Recent experience and perspectives on compliant implementation of ICH M7 and Q3D
Risk assessment of potentially genotoxic impurities and safety testing : critical issues and best practices for regulatory submissions
Extractables & leachables, elemental impurities in drugs and biologics: quality concerns, recommendations for comprehensive evaluations, upcoming changes in standards and regulations
Regulatory, toxicology, analytical practice for efficient mutagenic and elemental impurity identification, monitoring and control in pharmaceutical products, drug substances/APIs and excipients
Considerations for genotoxicity assessment of peptide/protein-related and novel oligonucleotide-based biotherapeutics
Valsartan incident and its implications for ICH M7
Dr. Susanne Glowienke, CH

Director, Head of In Silico & Impurity Safety, Preclinical Safety

Novartis Pharma AG

Dr. Andrew Teasdale, UK

Senior Principal Scientist / Head of Impurity Management & CMC Strategy


Dr. Alessandro Brigo, CH

Senior Principal Scientist, Toxicology Project Leader, Pharmaceutical Sciences

Roche Pharma Research & Early Development

Dr. Raphael Nudelman, IL

Director, Chemical & Computational Toxicology

Teva Pharmaceutical Industries Ltd.

Dr. Jacques Van Gompel, BE

EU Head Genetic Toxicology / Non Clinical Safety, small molecules

Janssen Pharmaceutica NV

Dr. Mike Urquhart, UK

Scientific Director / CMC Due Diligence / Lead for Small Molecules


Dr. Min Li, CN

Vice President, Analytical Operation

Huahai Pharmaceutical Co., Ltd

Dr. Tom van Wijk, NL

Senior Scientist / Analytical / Science and Technology

Abbott Healthcare Products BV

Dr. Fenghe Qiu, US

Senior Research Fellow

Boehringer Ingelheim Pharmaceuticals Inc

Carsten Baun Senholt, DK

Principal Toxicologist, Chief Technical Officer

Saxocon A/S

Dr. Catrin Hasselgren, US

Principal Scientist


Dr. George Johnson, UK

Associate Professor

Institute of Life Science at Swansea University

Carla Landolfi, IT

Head of

WEP Toxicology

Dr. Frank Liu, US

Associate Director, Head of Product Characterisation & Risk Assessment (PCARA) | DSRE | R&D


Dr. Manuela Pavan, IT

Principal Consultant

Innovatune srl

Dr. Suman Chakravarti, US

Vice President & Chief Scientific Officer




Sponsors and Partners