Genotoxic Impurities Summit: Nitrosamines & Beyond 2021

December 2^nd – December 3^rd2021

VIRTUAL CONFERENCE

CONFERENCE OVERVIEW

CONFERENCE OVERVIEW

The presence of nitrosamines and other mutagenic impurities might adversely impact the safety, quality and efficacy of drug substances and drug products. The estimation of the impurity profiles and their control and monitoring became an inevitable part of the successful development and production of new drugs. To comply with increased regulatory requirements and avoid expensive recalls, the proactive identification of genotoxic impurities should be established at every stage of drug development.

Together with industry experts we put an online meeting to present and explore varied opinions on how to tackle the challenges of mutagenic impurities. We will review drug impurity profiling strategies in line with regulatory guidelines, practical insights for compliance with the recent updates in ICH M7 and Q3D, new nitrosamine regulations, determination and calculation of nitrosamine impurities, risk assessment of genotoxic impurities, analytical challenges and genotoxicity prediction, development of acceptance criteria, latest advances in the assessment of elemental impurities.

Save your seat for our solution-packed webinar to be equipped with best practices and novel approaches to control genotoxic and elemental impurities.

WE WILL TALK ABOUT

WE WILL TALK ABOUT

risk assessment of nitrosamine impurities to optimize timelines and costs
mitigating nitrosamine contamination from raw material to final drug product
suitable analytical instruments for the detection of nitrosamine impurities
practical and compliant implementation of ICH M7 and ICH Q3D guidance
profiling of impurities in drug substances, intermediates and drug products
E&L as a source of impurities, eliminating the risks associated with E&L

WHO IS IT FOR?

WHO IS IT FOR?

CxOs, VPs, Directors, Heads, Managers, Principal Scientists of

Genotoxic Impurities/ GTIs/ Genotoxins/ Elemental Impurities
Genotoxicity/ Mutagenicity
Carcinogenicity/ Carcinogens
Genetic Toxicology/ Chemical Toxicology/ Computational Toxicology
Analytical Chemistry/ Analytical Development/ Analytical Science
Drug Discovery/ Drug Development/ Drug Substance
Drug Safety/ Compound Safety
Process Chemistry/ Process Development
Product Characterisation/ Risk Assessment
Pharmacokinetics/ Metabolism
Extractables & Leachables
API Development/ Degradation Products
LC-MS/ Mass Spectrometry
Good Laboratory Practice (GLP)/ Good Manufacturing Practice (GMP)
Regulatory Affairs & Compliance

Our Sponsors

Speaking Companies

Speaker Board

BECOME A SPEAKER

Rainer Rozenich

Business Development Manager (EE, CIS, ME & SSA)

Waters GesmbH

Maria João Sarmento

Head of Research & Development

QPLAB Pharma Services

Ulrich Rose

Head of Division A and Deputy Head of European Pharmacopoeia Department

EDQM, Council of Europe

Patrick Reichl

Toxicology Lead

Croma-Pharma GmbH

Tony Bristow

Principal Scientist for Measurement Science

AstraZeneca

Stephanie Simon

Head, Genetic Toxicology

Merck Healthcare KGaA

Reinhard Stidl

Senior Toxicologist - Managing Director

Safetree Consulting e.U.

Jan Wenzel

Scientist Computational and Systems Toxicology

Sanofi

Raphael Nudelman

Senior Director Impurity Expert, R&D Operations

Teva Pharmaceutical Industries Ltd.

Mark Cronin

Professor of Predictive Toxicology

Liverpool John Moores University

Naiffer Romero

Scientific & Compendial Affairs Sr. Manager

The United State Pharmacopeia (USP)

Alejandra Trejo-Martin

Sr. Associate Scientist

Gilead Sciences Inc.

Michael Burns

Principal Research Scientist

Lhasa Limited

Jack Steed

Technical Specialist

SCIEX

[Agenda] Genotoxic Impurities Summit: Nitrosamines & Beyond 2021

Download the full summit program to find speaker biographies, case studies, key takeaways, the day’s schedule, and details of each session.

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ATTENDEES IN 2021

ATTENDEES IN 2021

● AB Sciex Pte. Ltd. ● Adamed Pharma S.A. ● Alkaloid Skopje ● Almirall S.A. ● Angelini Pharma ● AstraZeneca ● Bausch Health ● Bayer AG ● Becton Dickinson ● Bilim Pharmaceuticals ● Cambrex Profarmaco Milano sr ● Cehtra ● Chemsafe Srl ● Chiesi Farmaceutici SpA ● CPAM du Cher (Assurance Maladie) ● Croma-Pharma GmbH ● Curia Italy s.r.l. ● Dechra Pharmaceuticals Manufacturing ● Dexcel LTD ● Dottikon Exclusive Synthesis AG ● EDQM, Council of Europe ● ERBC srl ● Ever Valinject GmbH ● FUJIFILM Toyama Chemical Co., Ltd. ● Gilead Sciences Inc. ● Givaudan International SA ● GlaxoSmithKline Consumer Healthcare ● Halmed ● Health Care Solution ● Helsinn Advanced Synthesis SA ● Hemofarm AD ● Janssen ● Janssen R&D (J&J) ● JAZMP ● Johnson & Johnson ● L’Oreal ● Lek Pharmaceuticals d.d. ● LGCGroup ● Lhasa Limited ● Liverpool John Moores University ● Malta Medicines Authority ● Merck Healthcare KGaA ● Merck/Sigma Aldrich ● Moehs Iberica, SL ● Novartis ● Orion Corporation ● Pfizer HealthCare ● Pfizer LIMITED ● Polpharma ● PRO.MED.CS Praha a.s. ● QPLAB ● Rajarshi Shahu College of Pharmacy ● Ravimiamet ● Ravimiamet – State Agency of Medicines ● Reading Scientific Services Ltd ● Safetree Consulting e.U. ● Sandoz ● Sanofi ● Sanofi Aventis ● Sanofi-Aventis ● Sidefarma S.A ● SK biotek Ireland ● State Agency of Medicines of Latvia ● State Institute for Drug Control ● Takeda ● Teva api ● Teva Pharmaceutical Industries LTD ● Teva Pharmaceuticals ● Teva Pharmaceuticals Ltd-Generic ● The United State Pharmacopeia (USP) ● Thermo Fisher Scientific ● Trasis ● Waters GesmbH