3rd Annual Impurities: Genotoxic and Beyond Summit
12-13

June 2019

Germany

Munich

Holiday Inn Munich - City Centre

Hochstraße 3, 81669

About

We are pleased to invite you to the 3rd Annual Impurities: Genotoxic and Beyond Summit scheduled for June 12th-13th, 2019. 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 t...

We are pleased to invite you to the 3rd Annual Impurities: Genotoxic and Beyond Summit scheduled for June 12th-13th, 2019. 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 June!

more info
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

Compliant practical implementation of recent updates in ICH M7 and Q3D
Proved strategies on impurity characterisation, qualification and risk assessment
Regulatory, toxicology, analytical experience for efficient mutagenic and elemental impurity identification, monitoring and control in pharmaceutical products, drug substances/APIs and excipients
Novel approaches for in silico genotoxity testing
Choosing the right strategy associated with the future industry developments and changing regulatory environment
Comprehensive extractables and leachables evaluation and its significance to pharmaceutical quality
Considerations for genotoxicity assessment of peptide/protein-related and novel oligonucleotide-based biotherapeutics
Latest recommendations on genotoxicity assessment of nanomaterials
Speakers
Dr. Andrew Teasdale, UK

Senior Principal Scientist / Head of Impurity Management & CMC Strategy

AstraZeneca

Dr. Henry Stemplewski, UK

Expert Assessor

MHRA

Dr. Susanne Glowienke, CH

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

Novartis Pharma AG

Dr. Laurence J. Harris, UK

Director, Global GMP Analytics

Pfizer

Dr. Raphael Nudelman, IL

Director, Chemical & Computational Toxicology

Teva Pharmaceutical Industries Ltd.

Dr. Wolfgang Muster, CH

Senior Principal Scientist / Toxicology Project Leader, Pharmaceutical Sciences

Roche Pharma Research & Early Dev. Roche Innovation Center Basel

Dr. Ping Wang, US

Material Science, Biotherapeutics Development / Discovery, Product Development & Supply

Janssen Research & Development

Dr. Frank Liu, US

Head of Product Characterisation & Risk Assessment (PCARA) / Toxicology/Nonclinical Development/R&D

Takeda

Dr. Brinda Mahadevan, IN

Sr. Associate Research Fellow / Director, Global Preclinical Development (GPD), Established Pharmaceuticals

Abbott Healthcare Pvt. Ltd.

Dr. Marc Audebert, FR

Research Director

INRA

Dr. Catrin Hasselgren, US

Senior Scientist

Genentech

Simone Carrara, IT

Extractables & Leachables and Impurity Characterization / Laboratory Manager

Eurofins BioPharma Product Testing Italy

Dr. Stefan Heck, CH

Business Development Manager

Intertek (Schweiz) AG

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