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6th Impurities: Genotoxic, Nitrosamine & Beyond Summit

  • 21st – 22nd June 2022
  • ONLINE flag 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, and extend partnership opportunities at the #VLGenotoxic event on June 21-22, 2022.

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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

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. 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.

Dr. BM Rao, IN

Head of Quality for Emerging Markets, Analytical Science & Technology (ASAT) & Corporate Quality control

Dr. Reddy’s Laboratories

Dr. BM Rao possess a PhD in chemistry and has about 31 years of work experience in pharmaceutical analytical R&D, quality control, and assurance functions in reputed organisations includes Janssen (pharmaceutical companies of Johnson & Johnson), Novartis, Zydus Cadila, Nicholas Piramal, and Dr. Reddy’s. He has extensive hands-on experience on analytical instruments related to chromatography, spectroscopy, and thermal analysis. He has exposure to various regulatory audits includes USFDA, EMEA, TGA, Health Canada, etc., and worked with reputed international consultants in QC remediation. He has about 80 scientific publications in reputed peer reviewed national/international journals and successfully guided eight part-time PhD candidates.

During his professional career he has been recognised for his contributions at work and won awards including Chairman’s Excellence Award from Dr. Reddy’s Laboratories (Feb. 2018 and Jan. 2003), “Standards of Leadership” from J&J at Janssen, Mumbai site (2010), and Best New Leader Award at SAI Life Sciences Limited (2013). He has extensively travelled to USA, Mexico, Germany, Belgium, Singapore, Brazil, and Malaysia, and interacted with several big and emerging biotech pharmaceutical analytical and quality experts.

Since September 2015, he has been working as head of quality for emerging markets, analytical science and technology (ASAT), and corporate quality control at Dr. Reddy’s Laboratories and providing technical leadership to the analytical method validations/transfers and quality control labs of APIs and formulations.

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

Dr. Joel Bercu, MPH, DABT is a senior director in the nonclinical safety and pathobiology group at Gilead Science and has 20 years of public health/toxicology experience in pharmaceuticals. His mission while at these positions is to protect the safety of staff, patients, and the environment. He leads the environmental and occupational toxicology (EOT) group at Gilead. The EOT group provides expert toxicological documentation for occupational health categorisations/occupational exposure limits, permitted/acceptable daily exposures for cleaning validation, environmental risk assessments, pharmaceutical impurity assessments (including mutagenic/carcinogenic impurities), QSAR assessments of impurities for ICH M7 compliance, deviations, leachables and extractables, and excipients.

The EOT group is also responsible for monitoring and reviewing toxicology tests including ecotoxicology, mutagenicity testing for impurities, and worker safety testing. Prior to joining Gilead Sciences, he worked at Eli Lilly and Amgen. He is a member of the Society of Toxicology and the Risk Assessment, Occupational and Public Health (where he served as president), and medical devices specialty sections. He has had several external committees, such as chairing the IQ/DruSafe impurities working group and on the board of directors for the Extractables Leachables Safety Information Exchange (ELSIE). He received his bachelor's from Texas A&M University, MPH from University of Texas - Houston School of Public Health, PhD from Indiana University, and is a Diplomate of the American Board of Toxicology (DABT).

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. 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. 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. George Johnson, UK

Associate Professor

Institute of Life Science at Swansea University

Dr. BM Rao, IN

Head of Quality for Emerging Markets, Analytical Science & Technology (ASAT) & Corporate Quality control

Dr. Reddy’s Laboratories

Dr. Rodney Parsons, US

Executive Director, Chemical Development

Bristol Myers Squibb

Dr. Joel Bercu, US

Executive Director

Gilead Sciences

Dr. Paulo Eliandro da Silva Junior, BR

Technical and Regulatory Director

INTEGRA CONSULTANCY

Dr. Carla Landolfi, IT

Founder & 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

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

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Congratulations to Vonlanthen with a successful conference! 

Look forward to meeting in-person!

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

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