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5th Impurities: Genotoxic and Beyond Summit

  • 21st – 22nd April 2021
  • Italy flag Italy

We are pleased to invite you to the 5th Annual Impurities: Genotoxic and Beyond Summit scheduled for April 21-22, 2021. This premier B2B event provides the appropriate platform to exchange experience with your peers, and to discuss expectations in the field.

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About

We are pleased to invite you to the 5th Annual Impurities: Genotoxic and Beyond Summit scheduled for April 21-22, 2021. This premier B2B event provides the appropriate platform to exchange experience with your peers, and to discuss expectations in the field.

The Summit will shed light on the critical considerations and best implementation practice of ICH M7 and Q3D, as well as recent strategies for efficient mutagenic and elemental impurities identification, monitoring and control. It is an honour and privilege to invite you to participate in this Summit. We look forward to welcoming you in April!

Who Should Attend 

Chief Executives, Directors, Vice Presidents, Department 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 
  • 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 
  • PGTIs 
  • Preclinical Drug Safety 
  • Process Chemistry 
  • Process-Related Impurities 
  • Product-Related Impurities 
  • Protein  
  • Purification 
  • Purge Factors 
  • Quality Assurance 
  • Quality By Design (QbD) 
  • Quality Control 
  • Regulatory 
  • R&D 
  • Safety Assessment 
  • Small Molecule 
  • Spectroscopy 
  • 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 ICH M7 and Q3D
  • Nitrosamines as part of ICH M7
  • Recent developments in the risk assessment, and recommendations on the safety qualification of impurities
  • Associated with GTI CMC regulatory pitfalls to avoid, and expectations in the field
  • Efficient strategies to assess, test and control impurities in pharmaceutical products, drug substances/APIs and excipients
  • Evaluation of extractables or leachables for genotoxic potential
  • Analytical, regulatory, toxicology approaches for compliant mutagenic, and elemental impurity identification, monitoring and control

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.

Dr. Susanne Glowienke, CH

Director, Head of In Silico & Impurity Safety, Preclinical Safety

Novartis Pharma AG

Dr. Susanne Glowienke graduated from the University of Stuttgart-Hohenheim, Germany, in food chemistry/technology. She then undertook research in the area of analytical chemistry and obtained her PhD degree from the faculty of food technology (cereal chemistry) in 1997 at the same university. In 2000, she joined Novartis in Basel, Switzerland, as a postdoc in the area of Q(SAR) for toxicological endpoints. Susanne was working as a lab head for bacterial mutagenesis in genetic toxicology, preclinical safety and is responsible for the QSAR predictions and impurity/excipient assessments at Novartis. Currently, Susanne is head of the in silico and impurity safety group in preclinical safety at Novartis.

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 Wuerzburg 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. 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

Dr. Susanne Glowienke, CH

Director, Head of In Silico & Impurity Safety, Preclinical Safety

Novartis Pharma AG

Dr. Alexander Amberg, DE

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

Sanofi Aventis Deutschland GmbH

Dr. Mike Urquhart, UK

Scientific Director / CMC Due Diligence / Lead for Small Molecules

GSK