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Genotoxic and Elemental Impurities

  • 3rd June 2020
  • Zoom flag Zoom
  • ONLINE

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

Join us virtually, learn and exchange a recent practical experience on the subject. The brochure contains additional information and key insights of the LIVE webinar.

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About

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.

Who Should Attend

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

  • Analytical Science

  • API Development

  • Assay Development

  • Carcinogens

  • Chemistry (Analytical, Organic, Medicinal, Protein)

  • Drug Safety

  • Elemental Impurities

  • Extractables & Leachables (E&L)

  • Genetic Toxicology

  • Genotoxic Impurities (GTIs)

  • Genotoxicity

  • Good Manufacturing Practices (GMP)

  • Good Laboratory Practice (GLP)

  • Impurities

  • In Silico

  • Microscopy

  • Mutagenic Impurities

  • Mutagenicity

  • Organic Synthesis

  • Permitted Daily Exposure (PDEs)

  • Purification

  • Quality Assurance

  • Quality by Design (QbD)

  • Quality Control

  • Regulatory
  • Toxicology

  • Validation

Key Practical Learning Points

  • 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 regulation
  • Regulatory, toxicology, analytical practice for efficient mutagenic and elemental impurity identification, monitoring and control in pharmaceutical products, drug substances/APIs and excipients

Dr. Laurence J. Harris, UK

Director, Global GMP Analytics

Pfizer

Dr. Laurence J. Harris joined Pfizer in Sandwich, UK, in 1999 as a process de­velopment chemist in chemical research and development (CRD), where he led project teams, API technology transfer, new API technology and green chemistry implementation programs. In 2008 he joined the analytical research and develop­ment (ARD) department in a team leader role before moving into the GMP ana­lytics function of ARD. He is currently a director within the global GMP analytics function with responsibilities for stability testing, drug product release, excipients and packaging component release. Since 2014 he has been leading efforts within Pfizer worldwide research and development to fully understand and implement ICH Q3D into the development workflow. This role has resulted in him becoming a key contributor to the cross-industry consortium working towards the delivery and use of the Lhasa elemental impurities excipient database in ICH Q3D risk as­sessments. In 2019 he is the industry co-chair for the Lhasa/industry consortium.

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

About 20 years of experience in the toxicology field in the pharmaceutical industry in management positions. Experience in safety programs for pharmaceuticals, cosmetics, medical devices, biocides, and other consumer products. She has experience in REACH, toxicological risk assessment, environmental risk assessment, and occupational toxicology. She’s the main author or co-author of several papers and posters, published in peer-reviewed journals or presented at international congresses.

Philippe Andre, CN

GMP Auditor

Qualandre

Philippe André is a Belgian pharmacist and GMP auditor. He is the director of Qualandre, an auditing company in Hangzhou, China. He lectured in pharmacology at the University of Tianjin between 2006 and 2011. He has since performed about 400 audits of pharmaceutical manufacturers in China, India, and other countries.

Dr. George Johnson, UK

Associate Professor

Institute of Life Science at Swansea University

Dr. George Johnson is an associate professor at the Institute of Life Science at Swansea University, UK. In 2006, George obtained his Ph.D. degree in Swansea, under the supervision of Professor Jim Parry, and since then he has developed a great interest in the statistical approaches and underlying mechanisms that support points of departure (PoD) for Swansea University genetic toxicity. This expertise has led George to be a steering member of the Health and Environmental Science Institute (HESI) and the Genetic Toxicology Technical Committee (GTTC), as well as being co-chair of the GTTC quantitative workgroup. His work includes improving the quantitative use of genetic toxicity data for human-health risk-assessment (Johnson et al., 2014, EMM), and he links this to his great interest in replacing, reducing and refining (3Rs) the use of animals in research.

Dr. Mike Urquhart, UK

Scientific Director / CMC Due Diligence / Lead for Small Molecules

GSK

Mike Urquhart (Ph.D.) has over 20 years’ experience within the Pharmaceutical industry, working mainly in process development as a synthetic organic chemist. Since starting at GSK, Mike has had positions of increasing responsibility ranging from lab chemist and team manager through to chemistry manufacturing and control (CMC) project manager. During his GSK career, Mike has led the primary development / delivery of 10 products, spanning early through to late phase development. Mike’s current roles are GSK CMC due diligence lead for small molecules and co-chair of the Genotoxic Risk Assessment (GRA) review team, where he is GSK subject matter expert. Mike also represents GSK on the Lhasa Mirabilis Pharmaceutical Consortium.

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

What our
participants
are saying

“It is a great opportunity to connect with colleagues, share our experience and process with and learn from our colleagues about their experience and process.”

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Frank Liu

Head of Product Characterization and Risk Assessment (PCARA) / Drug Safety Research and Evaluation (DSRE), R&D at Takeda

“I absolutely enjoyed the meeting with such a focused topic.”

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Brinda Mahadevan

Director, Global Pre-clinical Development at Abbott Laboratories

“Thanks a lot for all your organization which made this summit a real success.”

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Simone Carrara

E&L Laboratory Manager at Eurofins Biopharma Product Testing Italy