2nd Impurities: Genotoxic and Beyond Summit
07-08

June 2018

Germany

Berlin

Mövenpick Hotel Berlin

Schöneberger Str. 3, 10963

About

We are pleased to invite you to the 2nd Annual Impurities: Genotoxic and Beyond Summit scheduled for June 7th–8th, 2018, in Berlin, Germany. 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 practice of the implementation of recent updates in ICH M7 and Q3D, and novel strategies for efficient mutagenic and elemental impurity identification and contro...

We are pleased to invite you to the 2nd Annual Impurities: Genotoxic and Beyond Summit scheduled for June 7th–8th, 2018, in Berlin, Germany. 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 practice of the implementation of recent updates in ICH M7 and Q3D, and novel strategies for efficient mutagenic and elemental impurity identification and control. It is an honour and privilege to invite you to participate in this Summit. We look forward to welcoming you in Berlin in June!

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Who Should Attend

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

  • Research and Development
  • Drug Design
  • Safety Assessment
  • Chromatography
  • Spectroscopy
  • Purification
  • Formulation
  • Microscopy
  • Process Chemistry
  • GMP
  • Technology Transfer
  • Quality Assurance
  • Quality by Design (QbD)
  • Toxicology
  • Genotoxin
  • Genotoxic Impurities
  • Mutagenic impurities
  • Drug Discovery & Development
  • Pre-Clinical Drug Safety
  • Analytical Science
  • Mass Spectrometry
  • LC-MS
  • API Development
  • Assay Development
  • Chemistry (Analytical, Organic, Medicinal, Protein)
  • Organic Synthesis
  • Good Laboratory Practice
  • Validation
  • Quality Control
  • Regulatory
  • Impurities
  • Genetic Toxicology
  • Elemental impurities
  • Extractables and Leachables
Key Practical Learning Points of the Summit

Recent advances in Impurity profiling
Novel practice of the implementation of recent updates in ICH M7 and Q3D
Regulatory, scientific, analytical experience for efficient Mutagenic and Elemental Impurity identification, and control
Confident justification of Impurity limits
Choosing a right strategy associated with a future and regulatory predictions
Speakers
Dr. Andrew Teasdale, UK

Senior Principle Scientist / Head impurity management and CMC strategy

AstraZeneca

Dr. Lutz Müller, CH

Project Leader / Pharmaceutical Sciences

F. Hoffmann-La Roche Innovation Center Basel

Dr. Russ Naven, US

Associate Director / Global Discovery Toxicology Group

Takeda

Dr. Joerg Wichard, DE

Pharmaceuticals Division / Genetic Toxicology BLN

Bayer AG

Dr. Mike Urquhart, UK

Scientific Director / CMC Due Diligence Lead for Small Molecules

GSK

Dr. Lise Vanderkelen, BE

Dep. Head Micro & Pharma Services

Nelson Labs Europe

Dr. Raphael Nudelman, IL

Director, Chemical & Computational Toxicology

Teva Pharmaceutical Industries Ltd.

Dr. Fenghe Qiu, US

Senior Research Fellow

Boehringer Ingelheim Pharmaceuticals Inc

Dr. Alexander Amberg, DE

Head of In Silico Toxicology / R&D Preclinical Safety FF

Sanofi Aventis Deutschland GmbH

Dr. Tom van Wijk, NL

Senior Scientist / Analytical Science and Technology

Abbott Healthcare Products BV

Dr. George Johnson, UK

Associate Professor & Vice-President

Institute of Life Science at Swansea University / EEMGS

Dr. Catrin Hasselgren, US

Senior Scientist

Genentech

Lance Smallshaw, BE

Worldwide Analytical & Strategies Expert

UCB Biopharma sprl.

Dr. Tino Otte, CH

Senior Scientific Consultant

Intertek

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