Regulatory Hot Topics III
The Joint Pharmaceutical Analysis Group is holding a symposium on Regulatory Hot Topics in London on the 6th of December 2018. We present a poster: "A Workflow for In Silico Assessment of Genetic Toxicity and Application to Pharmaceutical Genotoxic Impurities under ICH M7". If you are attending and you would like to know more on what we do in this area, please feel free to drop me an e-mail in advance (firstname.lastname@example.org)
The advent of any new guidelines brings challenges. No matter how clear and definitive any guideline is, it typically only provides a framework. A framework that applicants and regulators alike need to firstly understand and then interpret and translate into actual practice. This transformation from principles, however helpful, to established practice can be difficult and can result, at least initially, in divergence. It is only though dialogue and the opportunity to discuss through effective forums such as this symposium that this process can be streamlined.
Guidelines are designed to address issues and through addressing issues provide opportunities to significantly enhance effectiveness. This effectiveness relates to all, applicant and regulator. This opportunity though can only be realised if there is mutual understanding of the challenges and collaboration in addressing them. This symposium seeks to bring together experts in the areas covered by the new and emerging guidelines to provide that exact opportunity.
Dr James Butler - GlaxoSmithKline
Julia Claus - Pfizer
Dr Graham Cook - Pfizer
Dr James Harvey - GlaxoSmithKline
Kevin Hughes - Colorcon
Matt Popkin - GlaxoSmithKline
Dr Helmut Rockstroh - Roche
Dr Andrew Teasdale - AstraZeneca