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Nitrosamine, Genotoxic and Elemental Impurities LIVE

  • 22nd April 2021
  • Hopin flag Hopin
  • ONLINE

Nitrosamine, Genotoxic and Elemental Impurities LIVE will provide practical regulatory, toxicology, analytical considerations, open discussion, Q&A, and interaction on:

  • efficient mutagenic and elemental impurities, incl. Nitrosamines, identification, monitoring, and control,
  • critical issues and best practices on quality, safety, and efficacy of drug products and substances,
  • expectations on regulatory submissions.

Join online conference, networking & virtual exhibition, learn and exchange a recent practical experience on the subject.

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About the Nitrosamine, Genotoxic and Elemental Impurities Live

Nitrosamines form a large group of genotoxic chemical carcinogens, which are probable human carcinogens. The recent N-Nitrosamine experiences have highlighted the importance of a risk assessment strategy for potential nitrosamines in the pharmaceutical product.

Based on the recent critical issues and lessons learned from the Sartans incidents, companies need to establish appropriate control strategies to prevent or minimize the presence of nitrosamine impurities, improve manufacturing processes.

Nitrosamine, Genotoxic and Elemental Impurities LIVE on 22 April 2021 will be hosted by the leading subject matter experts, providing an opportunity to

  • Exchange worldwide practice, and acquire additional clarifications related to the implementation of ICH M7
  • Share critical considerations and recommendations for assessment and control of DNA reactive (mutagenic) impurities
  • Address the challenges related to extractables and leachables, elemental impurities ( ICH Q3D )
  • Address uncertainties and misalignment in Nitrosamine safety assessment

Join #VLgenotoxic presentation, networking sessions + virtual expo, and obtain the recent practical regulatory, toxicology, analytical experience via:

  • learning, discussion, extending networking, asking questions, getting answers, initiation subject-specific roundtable discussion;
  • participation in the interactive discussion on the latest strategies and perspectives in the respective field;
  • Engagement in comprehensive, informative presentations / technical training related to:
  • efficient mutagenic and elemental impurities, incl. Nitrosamines, identification, monitoring, and control,
  • critical issues and best practices on quality, safety, and efficacy of drug products and substances,
  • expectations on regulatory submissions.

A digital certificate of attendance will be available for participants of Nitrosamine, Genotoxic and Elemental Impurities LIVE in April 2021.

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

  • Addressing uncertainties and misalignment in Nitrosamine safety assessment
  • Overcoming N-Nitrosamine analysis challenges in API and pharmaceutical products
  • Exchanging recent experiences and perspectives on the compliant implementation of ICH M7 and Q3D
  • Extractables and leachables, elemental impurities: overcoming quality concerns, shedding light on the future trends to control risk, progress in standards and regulations
  • Tackling regulatory, toxicology, analytical, critical issues towards efficient mutagenic and elemental impurity identification, monitoring, and control

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. Raphael Nudelman, IL

Director, Chemical & Computational Toxicology

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.

Patricia Parris, UK

Global Risk Assessment Services Toxicologist / Drug Safety Research & Development

Pfizer

Trish joined Pfizer in February 2020 as a Global Risk Assessment Services Toxicologist in Drug Safety R&D. Trish has a background in Genetic Toxicology and, over the last 12 years, has built expertise in mutagenic impurity, extractable and leachable, and contamination risk assessments. In recent years, Trish participated in the ICH M7 working group to develop Appendix 3 and co-authored the hydrogen peroxide monograph. In addition, she authored the vinyl acetate monograph in the subsequent publication Bercu et al., (2018). Trish is also the co-chair of the Extractables and Leachables Safety Information Exchange (ELSIE) PDE and Sensitisation Sub-teams and is an active member of the EFPIA working group to support ICHQ3E

Dr. Frank Liu, US

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

Takeda

Dr. Frank Liu has close to 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. Currently, he leads the pharmaceutical risk assessment and safety evaluation team responsible for the patient, environmental and occupational safety at Takeda. One of his major focusses and capabilities is to perform safety assessments 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).

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. 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.

Mr. Jon Bardsley, UK

Marketing Manager, Pharma & Biopharma

Thermo Fisher Scientific

Jon Bardsley has over a decade of experience in small-molecule pharmaceutical DMPK and regulated bioanalytical studies within large Pharmaceutical environments. His passion for the development of robust and accurate analytical methods for high-throughput studies has seen him also gain experience in contract research organizations. Jon sits on the Reid BioAnalytical committee of the Chromatography Society and is a subject matter expert in the bioanalysis community. Following a period as Senior Applications Specialist for Chromatography, Jon now holds the position of Vertical Marketing Specialist for Pharma & BioPharma within Thermo Fisher Scientific, with a view to bringing relevant technologies together to help solve customer challenges.

Nathan Anderson, US

Senior Business Development Manager

Waters Corporation

Nathan Anderson is a Senior Business Development Manager at Waters Corporation, focusing on the pharmaceutical market. Prior to Waters, Nathan consulted on commercialization feasibility and strategy projects, recommended external partnerships, identified strategic capability gaps, and standardized technology assessment processes for various organizations in the biopharmaceutical space. He was also a project manager for a pre-clinical oncology drug development CRO, as well as a research technician at Georgetown University and Johns Hopkins University. Nathan holds an M.B.A from Boston University's Questrom School of Business (Boston, MA) and an M.S. in Biology from American University (Washington, DC). 

Dr. Tino Otte, CH

Head of Sales and Consulting

Intertek (Schweiz) AG

Dr. Tino Otte is the Head of Sales and Consulting at Intertek in Switzerland. He joined the company in 2016. Tino is specialized in Extractables & Leachables Studies, Impurity Characterization, and Method Development. Tino has more than 13 years of experience in Analytical Chemistry, Pharmaceuticals, and Polymer Characterization. He holds a degree in Polymer-Chemistry from the University of Halle/Saale and a Ph.D. from the Darmstadt Technical University, where he graduated in 2010. Prior to joining Intertek, he worked at different CROs and Laboratory Instrument Manufacturers in Switzerland and Germany.

Jack Steed, DE

Technical Specialist EMEAI

SCIEX

Technical specialist with substantial experience of the pharma sector. Within the last 5 years, my main emphasis has been on small molecule analysis, specializing in high-performance liquid chromatography (HPLC) and high-performance liquid chromatography coupled with mass spectrometry (HPLC-MS).

Dr. Andrew Teasdale, UK

Senior Principal Scientist / Head of Impurity Management & CMC Strategy

AstraZeneca

Dr. Raphael Nudelman, IL

Director, Chemical & Computational Toxicology

Teva Pharmaceutical Industries Ltd.

Patricia Parris, UK

Global Risk Assessment Services Toxicologist / Drug Safety Research & Development

Pfizer

Dr. Frank Liu, US

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

Takeda

Dr. Susanne Glowienke, CH

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

Novartis Pharma AG

Dr. Alexander Amberg, DE

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

Sanofi Aventis Deutschland GmbH

Mr. Jon Bardsley, UK

Marketing Manager, Pharma & Biopharma

Thermo Fisher Scientific

Nathan Anderson, US

Senior Business Development Manager

Waters Corporation

Dr. Tino Otte, CH

Head of Sales and Consulting

Intertek (Schweiz) AG

Jack Steed, DE

Technical Specialist EMEAI

SCIEX

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Thank you so much for your nice words and to you and all of Vonlanthen to organize such an engaging virtual meeting. In my opinion, it was very well structured, and the online approach worked surprisingly well.  

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I thoroughly enjoyed this excellent conference.

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First, I want to congratulate you that it is a very successful meeting, and you did a great job organizing it! I could imagine that it is very challenging to do so in this challenging time.

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