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7th Impurities: Genotoxic, Nitrosamine & Beyond Summit

  • 15th – 16th March 2023
  • Italy flag Italy Milan

The recall of Valsartan has proved a critical need of a rational risk assessment strategy for potential nitrosamines in pharmaceutical products.

At the #VLGenotoxic 2023 event, along with focussing on the N-nitrosamines, we will explore the most important aspects around the detecting and reporting of genotoxic impurities, current investigations and regulatory, toxicological, analytical, pharmaceutical relevant prospects related to GTIs, as well as recent advances and further development and future considerations towards the different types of impurities present in drugs.

Join the keynote presentations and case studies, participate in the interactive panel discussions and Q&As, visit exhibitions, and extend partnership opportunities while learning about the advanced strategies and perspectives in the landscape of impurities and E&L at the 7th Impurities: Genotoxic, Nitrosamine & Beyond conference on March 15-16, 2023.

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About the 7th Impurities: Genotoxic, Nitrosamine & Beyond Summit (#VLGenotoxic)

The topic of the Valsartan recall, containing N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) impurities in several widely prescribed marketed pharmaceuticals, is rapidly evolving and has led to the following conclusions:

  • Requirement for an investigation into the potential for N-nitrosamine contamination and the mutagenic and carcinogenic risk to patients
  • Withdrawals, recalls, and delays in clinical trials related to ranitidine, nizatidine, metformin, rifampin/rifapentine, varenicline, and other drugs
  • Importance of a rational risk-assessment strategy for potential nitrosamines in the pharmaceutical product to avoid risk over- or underestimation

Critical issues and lessons learned from the Valsartan incident include:

  • Potential gap area to be identified in the current pharmaceutical practice that might affect the NMDA and NDEA impurities getting away from the focus of the FDA and drug manufacturers
  • Recent strategies and acceptable intake (AI) setting of nitrosamine impurities to be leveraged
  • Nitrosamine formation to be considered and applied to risk assessment of nitrosamine presence during pharmaceutical process in:
    • Drug substance (DS)
    • Drug product (DP)
    • Drug product packaging (DPP)
  • Pharmaceutical industry experts, working with research, academia, and toxicologists, have to generate knowledge and define methodologies able to shape future regulations for the control of N-nitrosamines as mutagenic impurities in pharmaceuticals
  • Appropriate control strategies to be established in order to prevent or minimise the presence of nitrosamine impurities, to optimise manufacturing processes, and eliminate increased carcinogenic risk to patients
  • Different stakeholders must contribute, including active pharmaceutical ingredients (APIs), excipients, primary packaging, and drug product manufacturers, due to risk analysis complexity

At the #VLGenotoxic 2023 event, alongside focussing on N-nitrosamines, we will:

  • Highlight the most important aspects around the detecting and reporting of genotoxic impurities in the pharmaceutical industry
  • Explore current investigations and regulatory, toxicological, analytical, pharmaceutical relevant prospects related to genotoxic impurities (GTIs)
  • Assume related impacts on implementation of ICH M7, providing guidance on the hazard identification and risk assessment process for genotoxic impurities in pharmaceuticals
  • Discuss relevant guidelines to avoid N-nitrosamine contamination in human medicines and alternative strategies to proceed with the initial risk evaluation confirmatory testing of the drug products and APIs identified to be at risk of N-nitrosamine formation
  • Continue discovering the recent advances, further development, and future considerations around the different types of impurities present in drugs, such as genotoxic impurities, nitrosamines, elemental impurities, extractables, leachables, and others

The forward-looking 7th Impurities: Genotoxic, Nitrosamine & Beyond Summit on March 15-16, 2023, will be hosted by the leading experts in the genotoxic and elemental impurities area.

Join the keynote presentations and case studies, participate in the interactive panel discussions and Q&As, visit exhibitions, and extend partnership opportunities while learning about the advanced strategies and perspectives in the landscape of impurities and E&L.

Engage in comprehensive, informative presentations, technical training, and workshops, highlighting the recent hurdles and progress related to:

  •  Practical regulatory, toxicology, analytical considerations on efficient mutagenic impurities identification, monitoring, and control (ICH M7)
  •  Critical issues and lessons learned on quality, safety, and efficacy of drug products
  •  Uncertainties and misalignment in nitrosamine safety assessment
  •  Regulatory requirements and perspectives on the nitrosamines
  •  Recent experience on 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 specialising in:

Analytical Science

API Development

Assay Development

Biotherapeutics

Carcinogenic Impurities

Carcinogenicity

Carcinogens

Chemistry (Analytical, Organic, Medicinal, Protein)

Chromatography

Degradation Products

DNA Reactive Impurities

DNA Reactivity

Drug Design

Drug Development

Drug Discovery

Drug Safety

Drug Substance

Elemental Impurities

Extractables & Leachables

Formulation

Genetic Toxicology

Genotoxic Impurities (GTI)

Genotoxicity

Genotoxin

GMP

Good Laboratory Practice

GRAs

GTIs

Impurities

In Silico

Large Molecule

LC-MS

Mass Spectrometry

Microscopy

Mutagenic Impurities

Mutagenicity

Nanomaterials

Nanoparticles

New Modality

Oligonucleotide

Organic Synthesis

Particles

Peptide

Potential Genotoxic Impurities (PGTIs)

Preclinical Drug Safety

Process Chemistry

Process-Related Impurities

Product-Related Impurities

Protein

Purification

Purge Factors

Quality Assurance (QA)

Quality By Design (QbD)

Quality Control (QC)

Regulatory

R&D

Safety Assessment

Small Molecule

Spectroscopy

Total Daily Intake (TDI)

Technology Transfer

Threshold of Toxicological Concern (TTC)

Toxicology

Validation

REQUEST A BROCHURE

To request an agenda for this Summit, please complete the details below. We will send you the agenda via email.

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, investigations, observations, and experiences related to nitrosamine
  • New frontiers in techniques, technologies and partnerships in genotoxic impurities identification, monitoring, and control
  • Recent developments in risk assessment and recommendations on the safety qualification of impurities
  • Ongoing advancements on the potential gaps affecting impurities identifying and control
  • Genotoxic impurities CMC regulatory requirements, 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 leachables (E&L) for genotoxic potential
  • Analytical, regulatory, and toxicology achievements and prospects for compliant mutagenic and elemental impurities identification, monitoring, and control

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 a director in preclinical safety at Novartis, Basel, Switzerland. She held several positions at Novartis, including positions in genetic toxicology and QSAR modelling. She is currently head of the impurity safety group and as such responsible for contaminant issues including nitrosamines. Susanne is part of and has led a number of industry expert groups within DruSafe IQ (US), European Federation of Pharmaceutical Industries and Associations (EFPIA), the Extractables and Leachables Safety Information Exchange (ELSIE), and several data sharing initiatives.

Dr. Raphael Nudelman, IL

Senior Director of 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. 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 practical implementation of ICH quality guidelines.

Irene Cecchini, IT

Principal Scientist

Merck KGaA 

Irene Cecchini works as Principal Scientist in Merck Biotech Product Development division based in Guidonia Site, close to Rome - Italy. She graduated in Analytical Chemistry at the University of Rome in 2003 and joined former Serono as an analytical methods development junior researcher in the same year. In the following years, she developed her expertise, particularly in Extractables & Leachables (E&L), elemental impurities, and sub-visible particles (SbVP) fields.

In 2016 she was appointed Lab Manager of the E&L group, where she managed E&L studies on the final biotech products containers, as well as for manufacturing processes materials (Single Use Systems) and coordinated analytical investigations linked to manufacturing processes issues. Starting June 2019, she has been appointed Principal Scientist in the Impurity Analytics Unit of Analytical Development Biotech Department dealing with chemical and biological process impurities. She is a member of ELSIE, BPOG, and SbVP industry consortia.

Dr. Carla Landolfi, IT

Founder & Toxicology Risk Assessor

ToxHub

Dr. Carla Landolfi has about 25 years of experience in toxicology field gained in the pharmaceutical industry, eight of them as manager to a toxicology group. She has solid knowledge in the development of safety programs for pharmaceuticals, cosmetics, food supplements, medical devices, biocides, and other consumer products.

Carla has broad experience with regulatory national and international guidelines and rules (ICH/EMA/FDA/GLP/ISO) and she has been the main or co-author of several papers and posters, published in peer-reviewed journals. She's also a professor at university masters as well as a founding editor of Archives of Clinical Toxicology.

Dr. Paulo Eliandro da Silva Junior, BR

Technical and Regulatory Director

INTEGRA CONSULTANCY

Dr. Paulo Eliandro da Silva Junior is a pharmacist-biochemist (USP) with a master's and PhD in medicinal chemistry, synthesis and drug discovery (FCFRP-USP, University of East Anglia – UEA, UK; Johannes Gutenberg University of Mainz – JGU, Germany). Paulo's experience in the pharmaceutical industry started in 2013 as a trainee at Novartis, Horsham, UK, in the global discovery chemistry department. After that Paulo worked mainly in regulatory affairs, quality audits, and drug product and drug substance development with focus on impurities control, including E&L, mutagenic impurities, such as nitrosamines, in his own consulting company, Integra Consultancy. Paulo also is a founder of another company, BIND, which is a startup for synthesis and characterisation of analytical standard for development processes, and teaches postgraduate courses that cover various pharmaceutical topics.

Dr. Rodney Parsons, US

Executive Director, Chemical Development

Bristol Myers Squibb

Dr. Rodney Parsons earned his bachelor’s degree in chemistry in 1986 from Trinity College and then received his PhD in 1992 from the University of Vermont under the guidance of Professor Martin E. Kuehne. His doctoral studies were focussed on the development of novel routes for the construction of indole alkaloids. He then carried out postdoctoral studies in organic chemistry with Professor Clayton H. Heathcock at the University of California at Berkeley. In 1994 he became a research scientist at Dupont-Merck Pharmaceutical Co., where he eventually rose to the rank of director. In 2001, after the acquisition of the DuPont Pharmaceuticals Co., he joined Bristol-Myers Squibb, where he is currently an executive director in the chemical process development department. He has been involved with drug development programs in a number of therapeutic areas including virology, cardiovascular, oncology, and metabolic diseases. His research interests include pharmaceutical process R&D, asymmetric synthesis, heterocyclic chemistry, and natural products total synthesis. He has been the BMS Mutagenic Impurity Assessment Committee (MIAC) chair since 2006. On the MIAC he leads an R&D-wide committee to establish control strategies for mutagenic impurities and align BMS internal practices with the evolving health authority regulations. Most recently he has led the end-to-end nitrosamine assessment and control process for the organisation. He has published over 40 papers and multiple patents in these areas.

Dr. Aloka Srinivasan, US

Principal and Managing Partner

RAAHA LLC

Aloka Srinivasan, PhD, the principal and managing partner of RAAHA LLC (www.raahallc.com) brings more than two decades of experience in the pharmaceutical industry, including nine years of progressive experience with the US FDA in the office of generic drugs, Lupin Pharmaceuticals, Lachman Consultants, and PAREXEL International. She provides strategic guidance to the pharmaceutical industry on regulatory and chemistry, manufacturing, and controls (CMC) for drug products and drug substances at all stages of development and for all types of regulatory submissions.

Aloka has supported the development of several new drugs and generics during her tenure in PAREXEL and Lachman from the CMC and regulatory perspective. She has worked closely with the industry and FDA related to development and approval of several complex 505(b)(2) applications as well as complex generic applications. She spearheaded the foundation of a division in FDA related to review of drug master files (DMF) for drug substances under GDUFA and played a pivotal role in writing the FDA Guidance for Industry: Initial Completeness Assessments for Type II API DMFs Under GDUFA and a QbR document for drugs substance, which is part of FDA Mapp. 5015.10. She was one of the main authors of the QbR-QOS (Question-based Review-Quality Overall Summary) for ANDAs, which is the current basis of review of generis at CDER/FDA.

Aloka is one of the world class experts in the area of nitrosamine impurities based on her research background and has been supporting the industry in addressing these carcinogenic impurities in the drugs.

Aloka received her PhD from University of Missouri (USA) under Dr. Richard N. Loeppky of nitrosamine fame. Her thesis was titled “A study of putative intermediates involved in the activation of beta-oxidized nitrosamines and nitrosation of N-substituted aziridines”. Aloka also spent seven years as a scientist at the National Cancer Institute, working for Dr. Larry K. Keefer, researching on nitrosamines in potential nitric oxide donor drugs.

Dr. Joerg Schlingemann, DE

Director, Principal Expert Quality Control Systems

Merck Healthcare KGaA

Joerg Schlingemann is a director and principal expert for quality control systems within Merck KGaA’s/EMD Serono’s healthcare quality unit. He studied molecular biology in Uppsala and Heidelberg, where he completed a doctorate degree at the German Cancer Research Center in 2005. He has 14 years of experience in the pharmaceutical industry from various roles within quality control and quality assurance. Since late 2019, Joerg has been leading EMD Serono’s analytical activities for N-nitrosamines. Joerg is married and has three children.

Dr. Dana Lena Budde, DE

Scientist Biocompatibility Testing / Product Development Bioreactor Characterisation

Sartorius Stedim Biotech GmbH

Dr. George Johnson, UK

Associate Professor

Institute of Life Science at Swansea University

George Johnson is an associate professor of genetic toxicology at Swansea University. He has expertise in the quantitative use of genetic toxicity data for hazard and risk assessment purposes and has an interest in high content and multiplex in-vitro test systems. He currently has active roles in the HESI-GTTC, IWGT 2022, COM and EEMGS-EXCOM, and carries out teaching, research, and consultancy at Swansea.

Marina Couva, CY

QPPV

Medochemie Ltd

Marina Couva has a lot of experience in the pharmaceutical industry in the fields of both quality and safety. She is a pharmacy graduate, a registered pharmacist in Cyprus, and also holds a master's degree in management.

She has served in a number of positions in Medochemie Ltd, a generics pharmaceutical company with headquarters in Lemesos (Limassol), Cyprus. She is a qualified person and currently holds the role of the QPPV, as well as the position of group quality senior manager, responsible for GDP. Her experience spreads across many issues relating to GxP compliance, combining quality and safety.

Dr. Arianna Bassan, IT

Principal Consultant

Innovatune

Arianna Bassan is a chemist with long-term expertise in toxicology. She graduated from the University of Padova (Italy) and she earned her PhD in chemical physics at the department of physics of Stockholm University (Sweden). She had worked several years in international environments including Stockholm University, MSD/Merck&Co., and the European Commission. Her main interest lies in the use of computational toxicology for human health hazard assessment. She also led several different scientific projects with focus on data management (e.g., development of the EFSA’s hazard database known now as OpenFoodTox, and management of pre-clinical data for pharma) and data curation.

She is currently principal consultant in Innovatune, where she is also partner in the firm. She provides integrated toxicology services making the most of (Q)SAR and read-across methodologies for different applications including regulatory submissions (e.g. ICH M7) and product development. She is engaged in numerous activities aiming at standardising industrial and regulatory applications of computational toxicology. She is currently involved in different projects such as the update of the EFSA pesticides genotoxicity database and the EMA-funded research project MutaMind (led by Fraunhofer ITEM) that aims at shedding light on the mutagenicity of different classes of nitrosamines to distinguish highly potent from less potent carcinogens.

Dr. Susanne Glowienke, CH

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

Novartis Pharma AG

Dr. Raphael Nudelman, IL

Senior Director of Impurity Expert, R&D Operations

Teva Pharmaceutical Industries Ltd.

Dr. Andrew Teasdale, UK

Senior Principal Scientist / Head of Impurity Management & CMC Strategy

AstraZeneca

Irene Cecchini, IT

Principal Scientist

Merck KGaA 

Dr. Carla Landolfi, IT

Founder & Toxicology Risk Assessor

ToxHub

Dr. Paulo Eliandro da Silva Junior, BR

Technical and Regulatory Director

INTEGRA CONSULTANCY

Dr. Rodney Parsons, US

Executive Director, Chemical Development

Bristol Myers Squibb

Dr. Aloka Srinivasan, US

Principal and Managing Partner

RAAHA LLC

Dr. Joerg Schlingemann, DE

Director, Principal Expert Quality Control Systems

Merck Healthcare KGaA

Dr. Dana Lena Budde, DE

Scientist Biocompatibility Testing / Product Development Bioreactor Characterisation

Sartorius Stedim Biotech GmbH

Dr. George Johnson, UK

Associate Professor

Institute of Life Science at Swansea University

Marina Couva, CY

QPPV

Medochemie Ltd

Dr. Arianna Bassan, IT

Principal Consultant

Innovatune

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What our
participants
are saying

An effective evaluation of potential genotoxic impurities is essential for the overall success of any drug development. #VLgenotoxic is a must attend event for all stakeholders in the genotoxic impurities landscape.

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This is well - known already many years conference with the speakers, topics and attendees high level, as well as excellent organization by Vonlathen. I recommend #VLgenotoxic for all professionals in charge of genotoxic impurities and E&L.

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Attendee

Nitrosamines looks to be one of the key topics in GTIs field. In-person touch with the experts at the #VLgenotoxic gives a huge push to solving many critical issues and providing perspectives to the future overlook of genotoxic impurities.

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