Back

Pharma

6th Impurities: Genotoxic, Nitrosamine & Beyond Summit

  • 21st – 22nd June 2022
  • Italy flag Italy Milan & Online

The recall of Valsartan (containing NDMA and NDEA impurities) has highlighted the importance of a risk assessment strategy for potential nitrosamines in the pharmaceutical product.

In addition to focusing on the N-Nitrosamines, exploring current investigations, regulatory, toxicological, analytical, pharmaceutical prospects, and related impacts on implementation of ICH M7, at the #VLGenotoxic event we will continue discovering the recent advances around mutagenic impurities and extractables and leachables.

Join the keynote presentations, case studies, interactive panel discussions, Q&A on the advanced strategies and perspectives in the field of impurities, extractables and leachables, visit an exhibition and extend partnership opportunities at the #VLGenotoxic event on June 21-22, 2022.

Read more

About the 6th Impurities: Genotoxic, Nitrosamine & Beyond Summit (#VLGenotoxic)

The recall of Valsartan (containing N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) impurities) has highlighted the importance of a risk-assessment strategy for potential nitrosamines in the pharmaceutical product. NDMA and NDEA are probable human carcinogens and might be introduced into the finished products because of the manufacturing processes used to make the drug substance.

Based on the critical issues and lessons learned from the Valsartan incident:

  • Potential gap area to be identified in the current pharmaceutical practice that might affect the NMDA and NDEA impurities getaway from FDA's the drug manufacturers' focus
  • Appropriate control strategies to be established in order to prevent or minimise the presence of nitrosamine impurities, and to optimise manufacturing processes
  • Various stakeholders have to be involved, including active pharmaceutical ingredients (APIs), excipients, primary packaging and drug product manufacturers, due to risk analysis complexity

In addition to focussing on the N-nitrosamines, exploring current investigations, regulatory, toxicological, analytical, pharmaceutical prospects, and related impacts on implementation of ICH M7. At #VLGenotoxic we will continue discovering the recent advances around mutagenic impurities and extractables and leachables.

The 6th Impurities: Genotoxic, Nitrosamine & Beyond Summit on June 21-22, 2022, will be hosted by prominent global experts in the genotoxic and elemental impurities area.

Join the keynote presentations, case studies, interactive panel discussions, Q&A on the advanced strategies and perspectives in the field of impurities, extractables and leachables, visit an exhibition and extend partnership opportunities.

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 extractables and 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 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 the 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/or leachables (E&L) for genotoxic potential
  • Analytical, regulatory, and toxicology achievements and prospects for compliant mutagenic and elemental impurities 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 practical implementation of ICH quality guidelines.

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. 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. 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 of Wuerzburg (Germany) 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. 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. Joel Bercu, US

Executive Director

Gilead Sciences

Shital Pathak, IN

Vice President, Head of Analytical Research & Development (Formulations)

Glenmark Pharmaceuticals

Dr. Alain Duguet, FR

Consultant for Pharmaceutical Industry

PharmApi

Dr. Carla Landolfi, IT

European Registered Toxicologist (ERT) | CEO - Toxicology Risk Assessor

ToxHub

Dr. Carla Landolfi graduated in chemistry and pharmaceutical technology from Rome University. She has more than 20 years of experience in the toxicology field gained in the pharmaceutical industry, 10 of them as manager to the toxicology group. She's the main or co-author of several papers and posters, has published in peer-reviewed journals, and she's an invited speaker at international conferences as well as the founding editor of archives of clinical toxicology. In 2020, she founded the ToxHub, a consultancy company specialised in toxicological risk assessment and regulatory toxicology.

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.

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. Thurloch O'Criodain, CH

Quality and Compliance Expert

TOC Consulting

Thurloch O’Criodain has been working in quality management for over 40 years. He gained his PhD in chemistry from the National University of Ireland in 1980, and he became a qualified person in 1984. Over the years, he has worked with some of the biggest names in the industry: Abbott Laboratories, Wyeth, Johnson & Johnson, and Novartis. Thurloch has worked in leadership positions both locally and globally. Since 2018, he has been working as a consultant, helping companies to troubleshoot quality and compliance issues. One of those issues is the contamination of sartans with nitrosamines, and that is what he is here to talk to us about today.

Dr. Andrew Teasdale, UK

Senior Principal Scientist / Head of Impurity Management & CMC Strategy

AstraZeneca

Dr. Raphael Nudelman, IL

Senior Director Impurity Expert, R&D Operations

Teva Pharmaceutical Industries Ltd.

Dr. George Johnson, UK

Associate Professor

Institute of Life Science at Swansea University

Dr. Alexander Amberg, DE

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

Sanofi Aventis Deutschland GmbH

Dr. Rodney Parsons, US

Executive Director, Chemical Development

Bristol Myers Squibb

Dr. Joel Bercu, US

Executive Director

Gilead Sciences

Shital Pathak, IN

Vice President, Head of Analytical Research & Development (Formulations)

Glenmark Pharmaceuticals

Dr. Alain Duguet, FR

Consultant for Pharmaceutical Industry

PharmApi

Dr. Carla Landolfi, IT

European Registered Toxicologist (ERT) | CEO - Toxicology Risk Assessor

ToxHub

Dr. Aloka Srinivasan, US

Principal and Managing Partner

RAAHA LLC

Dr. Joerg Schlingemann, DE

Director, Principal Expert Quality Control Systems

Merck Healthcare KGaA

Marina Couva, CY

QPPV

Medochemie Ltd

Dr. Thurloch O'Criodain, CH

Quality and Compliance Expert

TOC Consulting

BROCHURE

Request the 6th Impurities: Genotoxic, Nitrosamine & Beyond Summit brochure and find out the latest topics and ideas that will be shared.

Request

Please fill in your e-mail address below and we will process your request in a moment.

What our
participants
are saying

This is very comprehensive and scientific meeting with the subjects applicable for my work, which are being commented by the top experts.

1
2
3
4
5

PREVIOUS

Attendee

Congratulations to Vonlanthen with a successful conference! 

Look forward to meeting in-person!

1
2
3
4
5

PREVIOUS

Attendee

I would of course be delighted to join and I would be very happy to discuss nitrosamines

1
2
3
4
5

PREVIOUS

Attendee