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5th Impurities: Genotoxic and Beyond Summit

  • 22nd – 23rd September 2021
  • Hopin flag Hopin
  • ONLINE

The recall of Valsartan containing NDMA by several companies has highlighted the importance of a risk assessment strategy for potential nitrosamines in the pharmaceutical product. 

Based on the critical issues and lessons learn from the sartans incidents, the appropriate control strategies to be established in order to prevent or minimize the presence of nitrosamine impurities, and to improve manufacturing processes.  

Besides looking precisely on the N-Nitrosamines, exploring current investigations, regulatory expectations, and related impacts on implementation of ICH M7, at #VLgenotoxic we will continue discovering the advances around mutagenic impurities and extractables & leachables. 

Join LIVE the interactive discussion, Q&A and networking sessions on the advanced strategies and perspectives in the respective field, and visit a virtual expo. 

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About the Impurities: Genotoxic and Beyond Summit ( #VLgenotoxic) 

The recall of Valsartan containing NDMA be several companies has highlighted the importance of a risk assessment strategy for potential nitrosamines in the pharmaceutical product. 

Based on the critical issues and lessons learn from the sartans incidents, the appropriate control strategies to be established in order to prevent or minimize the presence of nitrosamine impurities, and to improve manufacturing processes.  

Due to risk analysis complexity, many stakeholders have to be involved, including makers of active pharmaceutical ingredients (APIs), excipients, primary packaging manufacturers and drug product manufacturers. 

Besides looking precisely on the N-Nitrosamines, exploring current investigations, regulatory expectations, and related impacts on implementation of ICH M7, at #VLgenotoxic we will continue discovering the advances around mutagenic impurities and extractables & leachables. 

The 5th Impurities: Genotoxic and Beyond Summit LIVE on September 22-23 2021 will be hosted by the global leading experts in the genotoxic and elemental impurities landscape. 

Join LIVE the interactive discussion, Q&A and networking sessions on the advanced strategies and perspectives in the respective field, and visit a virtual exhibition. 

Engage in comprehensive, informative presentations (technical training), that clearly outline the recent challenges and the progress that has been achieved: 

  • practical regulatory, toxicology, analytical considerations on efficient mutagenic impurities identification, monitoring, and control (ICH M7) 
  • critical issues and best practices on quality, safety, and efficacy of drug products
  • uncertainties and misalignment in Nitrosamine safety assessment 
  • regulatory requirements and expectations on the nitrosamines 
  •  advances in extractables & leachables (E&L) and elemental impurities (ICH Q3D) 

A digital certificate of attendance is provided for #VLgenotoxic participants. 

Who Should Attend 

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

  • Analytical Science 
  • Active Pharmaceutical Ingredient (API )Development  
  • Assay Development  
  • Carcinogens 
  • Chemistry (Analytical, Organic, Medicinal, Protein) 
  • Drug Safety 
  • Elemental Impurities 
  • Extractables & Leachables (E&L) 
  • Genetic Toxicology 
  • Genotoxic Impurities (GTIs) 
  • Genotoxicity 
  • Good Manufacturing Practices (GMP) 
  • Good Laboratory Practice (GLP) 
  • Impurities 
  • In Silico 
  • Microscopy 
  • Mutagenic Impurities 
  • Mutagenicity 
  • N-Nitrosamine 
  • Organic Synthesis 
  • Permitted Daily Exposure (PDEs) 
  • Purification 
  • Quality Assurance 
  • Quality by Design (QbD) 
  • Quality Control 
  • Regulatory 
  • Toxicology 
  • Validation 
  • Quantitative Structure-Activity Relationships ((Q)SAR)  

KEY PRACTICAL LEARNING POINTS

  • Critical considerations on compliant implementation of ICH M7 and Q3D
  • Assessment and control of DNA reactive (mutagenic) N-nitrosamines impurities to limit potential carcinogenic risk
  • Uncertainties, misalignment, ongoing investigations, and the outlook related to Nitrosamine
  • Recent developments in the risk assessment, and recommendations on the safety qualification of impurities
  • GTI CMC regulatory pitfalls and expectations in the field
  • Efficient strategies to assess, test and control impurities in pharmaceutical products, drug substances /APIs and excipients
  • Evaluation of extractables and/or leachables ( E&L) for genotoxic potential
  • Analytical, regulatory, and toxicology advancements for compliant mutagenic and elemental impurities identification, monitoring, and control

Dr. Raphael Nudelman, IL

Senior Director Impurity Expert, R&D Operations

Teva Pharmaceutical Industries Ltd.

Raphael Nudelman holds a master's of pharmaceutical sciences from the Hebrew University of Jerusalem and a PhD in organic chemistry from the Weizmann Institute of Science in Rehovot, Israel. He held research fellow positions in the US Air Force Research Lab in Aberdeen Proving Ground, Maryland, USA, and at the Duke University Medical Center, North Carolina, USA. He has been with Teva Pharmaceutical Industries in Israel since 2003 and held research positions in the medicinal chemistry department and the patent department. Since 2010, he has been the head of chemical and computational toxicology in Teva's non-clinical safety department. From 2011-16, Raphael also served as the president of the medicinal chemistry section of the Israel Chemical Society.

Dr. Susanne Glowienke, CH

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

Novartis Pharma AG

Dr. Susanne Glowienke graduated from the University of Stuttgart-Hohenheim, Germany, in food chemistry/technology. She then undertook research in the area of analytical chemistry and obtained her PhD degree from the faculty of food technology (cereal chemistry) in 1997 at the same university. In 2000, she joined Novartis in Basel, Switzerland, as a postdoc in the area of Q(SAR) for toxicological endpoints. Susanne was working as a lab head for bacterial mutagenesis in genetic toxicology, preclinical safety and is responsible for the QSAR predictions and impurity/excipient assessments at Novartis. Currently, Susanne is head of the in silico and impurity safety group in preclinical safety at Novartis.

Dr. Andrew Teasdale, UK

Senior Principal Scientist / Head of Impurity Management & CMC Strategy

AstraZeneca

Andrew Teasdale, PhD, is a senior principal scientist in impurity management and external advocacy at AstraZeneca. Andrew has over 20 years' experience in the pharmaceutical industry as an analytical chemist and within quality assurance and regulatory roles. In his current role, he chairs AstraZeneca's Impurity Advisory Group. Andrew has published over 30 papers relating to genotoxic impurities and other impurity-related matters and has been a speaker at many international conferences. He has also led a number of industry expert groups; these include both safety and quality groups within Pharmaceutical Research and Manufacturers of America (PhRMA), European Federation of Pharmaceutical Industries and Associations (EFPIA), Product Quality Research Institute (PQRI), and the Extractables and Leachables Safety Information Exchange (ELSIE). Andrew led the recent development of the ICH M7 addendum table from an industry perspective and was the inventor of the purge tool concept, Mirabilis™. He also published a book addressing genotoxic impurities, 'Genotoxic Impurities Strategies for Identification and Control' (Wiley and Son), and is soon to publish as editor a book focussed on the practical implementation of ICH Quality Guidelines.

Dr. Mike Urquhart, UK

Scientific Director / CMC Due Diligence / Lead for Small Molecules

GSK

Mike Urquhart (Ph.D.) has over 20 years’ experience within the Pharmaceutical industry, working mainly in process development as a synthetic organic chemist. Since starting at GSK, Mike has had positions of increasing responsibility ranging from lab chemist and team manager through to chemistry manufacturing and control (CMC) project manager. During his GSK career, Mike has led the primary development/delivery of 10 products, spanning early through to late phase development. Mike’s current roles are co-chair of the Impurities Oversight Panel, where he is a GSK mutagenic impurity risk assessment subject matter expert and Scientific Director as well as the GSK Drug Substance nitrosamine risk assessment lead for small molecules.  Mike also represents GSK on the Lhasa Mirabilis Pharmaceutical Consortium and presents externally on best practice for mutagenic impurity control strategies for pharmaceutical products.

Philippe Andre, CN

GMP Auditor

Qualandre

Philippe André is a Belgian pharmacist and GMP auditor. He is the director of Qualandre, an auditing company in Hangzhou, China. He lectured in pharmacology at the University of Tianjin between 2006-11. He has since performed about 400 audits of pharmaceutical manufacturers in China, India, and other countries. 

Dr. Alexander Amberg, DE

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

Sanofi Aventis Deutschland GmbH

Alexander Amberg performed his doctoral studies at the department of toxicology and pharmacology at the University Wuerzburg and obtained his PhD in biochemical toxicol­ogy in 2000. In 2001, he joined the early and exploratory safety group of Sanofi, and in this position has been responsible for in silico/computational toxicology analysis glob­ally at Sanofi. Since 2007, he has been registered as a European registered toxicologist (ERT) after getting his examination of Fachtoxikologe DGPT from the German Society of Toxicology. His major research interests are development of new in silico prediction models for different toxicity endpoints and data management of in-house data in com­bination with publicly available toxicity data, to support drug development in research and development. For this he is also a member of different internal expert advisory groups as well as external initiatives, like the IMI eTOX consortium (for toxicity data sharing and development of new expert systems for in silico toxicity prediction), the IMI SafeSciMET education program and others. With respect to genotoxic impurities (GTIs), he was actively involved in the preparation of the White Paper for the use of in silico systems in the scope of ICH M7 and other publications regarding GTIs. Internally he is member of the task force to support the in-house implementation of ICH M7.

Dr. Frank Liu, US

Director, Safety and Toxicology

Estee Lauder

Dr. Frank Liu has more than 10 years’ experience in chemical risk assessment and safety evaluation, many years of solid research experience, significant publication and paper review experience, and successful NIH grant application record in DNA and telomere damage and repair and general toxicology. After his master’s and PhD education in environmental toxicology and two postdoctoral trainings in pharmaceutical sciences and human toxicology, Frank moved to the product safety assessment area in the personal care and pharmaceutical product industries. One of his major responsibilities while working in the pharmaceutical industry is to perform safety assessment of impurities such as extractables, leachables, intermediates, catalysts, particulate matters, and of genotoxic, elemental and solvent impurities using classic and alternative approaches (e.g., read-across, in silico, QSAR, and TTC). Currently, he leads a team responsible for safety assessment of personal care products.

Dr. George Johnson, UK

Associate Professor

Institute of Life Science at Swansea University

Dr. George Johnson is an Associate Professor in the Institute of Life Science at Swansea University, UK. George is co-chair of the quantitative workgroup within the Health and Environmental Science Institute (ILSI-HESI) Genetic Toxicology Technical Committee (GTTC).  

Dr. Manuela Pavan, IT

Principal Consultant

Innovatune srl

Manuela Pavan provides toxicology consulting services to the industry for the evaluation of human health endpoints, including the genotoxic and carcinogenic potential assessment of pharmaceutical impurities. Her main interest lies in the use of in silico approaches (read-across, QSAR, alerts, grouping, categories) that the industry uses in compliance with regulations such as ICH M7, REACH, CLP guidelines, biocides, and cosmetics guidelines; she is then committed to combining information and data coming from different sources in an efficient and informed way. Her experience thus includes topics such as weight of evidence, integrated testing strategy, chemical safety assessment. She was working for the former European Chemicals Bureau (ECB) at JRC of the European Commission from 2004 to 2008, where she was actively involved in developing technical guidance documents for REACH.

Nadim Mira, FR

Product Marketing Analyst II

Waters (Andrew Alliance)

Nadim Mira graduated in 2013 from the University of Orleans, France, with a master’s degree in biochemistry, molecular biology, and biotechnology. He then joined the department of fundamental microbiology at the University of Lausanne, Switzerland, as a PhD student in an SNF-funded research project. After two years, he decided to pursue a corporate career instead of working in academic research. In 2018, he completed a second master’s degree in sales and marketing in the life science industry at the University of Grenoble Alpes, France, before joining Andrew Alliance as an inside sales representative. In 2019, he moved to a new role in the marketing team, serving as a product marketing analyst responsible for protocol publication and labware integration in the OneLab cloud-based software.

Dr. Marc Audebert, FR

Research Director

INRA

Dr. Marc Audebert is a research director at INRA (France). He studies the relation­ship between the biotransformation of xenobiotics and their genotoxicity. He has developed a novel genotoxic assay based on the quantification of histones H2AX/ H3 phosphorylation, with simultaneous examination of the cytotoxicity and geno­toxicity of xenobiotics on human cells. Using this assay, he successfully evaluated the genotoxic potential of several groups of food contaminants (including pesti­cides, polycyclic aromatic hydrocarbons, heterocyclic aromatic amines, mycotoxins, bisphenol, heavy metals, etc.), including at low concentrations, using single com­pounds as well as mixtures. Marc also investigates the genotoxic mode of action of food contaminants (DNA adducts, aneugens, oxidative stress). He has coordinated or participated to several projects contributing to establishing the scientific basis for predicting and assessing the genotoxic effects of multi-component mixtures.

Dr. Raphael Nudelman, IL

Senior Director Impurity Expert, R&D Operations

Teva Pharmaceutical Industries Ltd.

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

AstraZeneca

Dr. Mike Urquhart, UK

Scientific Director / CMC Due Diligence / Lead for Small Molecules

GSK

Philippe Andre, CN

GMP Auditor

Qualandre

Dr. Alexander Amberg, DE

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

Sanofi Aventis Deutschland GmbH

Dr. Frank Liu, US

Director, Safety and Toxicology

Estee Lauder

Dr. George Johnson, UK

Associate Professor

Institute of Life Science at Swansea University

Dr. Manuela Pavan, IT

Principal Consultant

Innovatune srl

Nadim Mira, FR

Product Marketing Analyst II

Waters (Andrew Alliance)

Dr. Marc Audebert, FR

Research Director

INRA

BROCHURE

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What our
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This is very informative and scientific meeting facilitating my understanding of the currently critical topics in relation to my work.

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Want to congratulate the team at Vonlanthen for a great event!  I really enjoyed it and learned a lot. 

Look forward to the September meeting!

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It was a really enjoyable conference (as always!!

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