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Genotoxic Impurities - Methods to Identify and Control

4-week online academy | 2 hours per week

Next intake begins 1 April 2019

Online Academy

The control of genotoxic impurities is crucial for ensuring regulatory compliance. With the implementation of increasingly stringent regulations for impurity levels, it is more important than ever for drug manufacturers to employ effective strategies for identifying, analysing and controlling GIs in their products.

Led by Andrew Teasdale, this 4 week course will provide you with the latest updates on regulatory expectations, clarifying any grey areas to outline your responsibilities as the manufacturer. It will also advise on crucial aspects of risk assessments and safety testing.

This course is approved by the Royal Society of Chemistry,and is also available as a face-to-face training course - check the website for dates>>

Andrew Teasdale, PhD, has over twenty years’ of experience in analytical chemistry and quality assurance and has published a number of papers relating to GIs as well as presented at a number of conferences. He has also led two expert groups working in the field of genotoxic impurities, including an analytical group in the UK and a Project Quality Research Institute (PQRI) working group, which focused on the critical area of sulfonate ester formation and control. He also led sub-groups within both EFPIA and PhRMA during the development of ICH M7 and currently leads a team developing the addendum to ICH M7 which will provide definitive limits for common mutagenic reagents.

  • Examine in detail the ICH M7, EMA and FDA guidelines
  • Review implementation strategies of the ICH guideline for new chemical entities and generics
  • Explore common in silico systems used and evaluate their strengths and weaknesses 
  • Discover methods to assess potential mutagenicity impurities 
  • Discuss the In-Vitro and In-Vivo tests available to examine mutagenic impurities 
  • Gain the knowledge to implement a successful strategic MI analysis with minimal impact on development times

This course has been designed so that you don't have to take much time out of the office, therefore is perfect for individuals or groups from the same department to attend at the same time. 

This course is relevant to anyone involved in identifying/analysing/controlling/reporting of GTIs.

What is an Online Academy course? 

Online academy is a new online, interactive and engaging education tool designed to maximise learning for professionals with busy schedules and/or small training budgets.
The online academy brings alike professionals together and gives you the opportunity to share ideas and questions via the discussion forum creating your own professional community. Our on-demand feature means the content is available as and when you need it allowing greater flexibility to your professional development and learning.

Over 4 weeks students will learn through:

  • 7 modules, split up into multiple bitesize recorded videos
  • Quizzes to test your knowledge
  • Revisit the content with unlimited access to all the materials for 2 months
  • Access the discussion forum and interact with other students and the trainer
  • Direct contact with the trainer through the forum during the 4 weeks the course is running
  • Additional content such as slides and white papers available to download
rsc approved training

This course is approved by the Royal Society of Chemistry for the purpose of continuing professional development. 

As the UK’s professional body for chemical scientists, the Royal Society of Chemistry supports professional development by listing excellent training opportunities on their database of approved courses. The approval process is one of peer review, involving assessment against set criteria by members that are expert in their field.

Watch the Online Academy Video

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