Genotoxic and Elemental Impurities
03-03

June 2020

ONLINE

ZOOM

About

Genotoxic and Elemental Impurities LIVE webinar will provide practical regulatory, toxicology, analytical considerations on: • efficient mutagenic and elemental impurity identification, monitoring and control • critical issues and best practices on quality, safety and efficacy of drug products • expectations on regulatory submissions Genotoxic and Elemental Impurities LIVE webinar on 3 June 2020 will be hosted by the leading subject matter experts, providing an opportunity to participate in the interactive discussion on the recent strategies a...

Genotoxic and Elemental Impurities LIVE webinar will provide practical regulatory, toxicology, analytical considerations on: • efficient mutagenic and elemental impurity identification, monitoring and control • critical issues and best practices on quality, safety and efficacy of drug products • expectations on regulatory submissions Genotoxic and Elemental Impurities LIVE webinar on 3 June 2020 will be hosted by the leading subject matter experts, providing an opportunity to participate in the interactive discussion on the recent strategies and perspectives in the respective field and to engage into comprehensive informative presentations / technical training. Join us virtually, learn and exchange recent practical experience on: - practical regulatory, toxicology, analytical considerations on efficient mutagenic and elemental impurity identification, monitoring and control - critical issues and best practices on quality, safety and efficacy of drug products - expectations on regulatory submissions Digital certificate of attendance will be available for participants. The brochure contains additional information and key insights of the LIVE webinar.

more info
Who Should Attend

Chief Executives, Vice Presidents, Directors, Heads, Leaders and Managers specialising in:

  • Analytical Science
  • Assay Development
  • Chemistry (Analytical, Organic, Medicinal, Protein)
  • Elemental Impurities
  • Genetic Toxicology
  • Genotoxicity
  • Good Laboratory Practice (GLP)
  • In Silico
  • Mutagenic Impurities
  • Organic Synthesis
  • Purification
  • Quality by Design (QbD)
  • Regulatory
  • Validation
  • API Development
  • Carcinogens
  • Drug Safety
  • Extractables & Leachables (E&L)
  • Genotoxic Impurities (GTIs)
  • Good Manufacturing Practices (GMP)
  • Impurities
  • Microscopy
  • Mutagenicity
  • Permitted Daily Exposure (PDEs)
  • Quality Assurance
  • Quality Control
  • Toxicology
Key Practical Learning Points of the Summit

Recent experience and perspectives on the compliant implementation of ICH M7 and Q3D
Risk assessment of potentially genotoxic impurities and safety testing: critical issues and best practices for regulatory submissions
Extractables and leachables, elemental impurities: quality concerns, recommendations for comprehensive evaluations, upcoming changes in standards and regulations
Regulatory, toxicology, analytical practice for efficient mutagenic and elemental impurity identification, monitoring and control in pharmaceutical products, drug substances/APIs and excipients
Speakers
Dr. Laurence J. Harris, UK

Director, Global GMP Analytics

Pfizer

Patricia Parris, UK

Global Risk Assessment Services Toxicologist / Drug Safety Research & Development

Pfizer

Carla Landolfi, IT

European Registered Toxicologist (ERT)/ Founder & Toxicology Risk Assessor

ToxHub-Consulting

Philippe Andre, CN

GMP Auditor

Qualandre

Dr. George Johnson, UK

Associate Professor

Institute of Life Science at Swansea University

Dr. Mike Urquhart, UK

Scientific Director / CMC Due Diligence / Lead for Small Molecules

GSK

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