Overview

Issues from manufactured chemical products remain ever-present. Chemicals with new properties are being developed and existing products become used in new applications. From time-to-time chemicals come back into the public eye, whether in the context of a disaster (for example the recent explosion in Beirut) or the need to rapidly develop new products (for example to tackle the COVID-19 coronavirus).  

The issues in risk management of chemicals range from safety evaluation and manufacture through to distribution, use and disposal. They will also vary between single products (for example fertilisers, cleaning agents and drugs) and products in combination (for example implantable medical devices).

In this series of webinars, key regulators will discuss existing approaches and the policy and practical challenges for the future.

Presenters

Michelle Kelly, Biological Safety Manager

Michelle is the biological safety manager for the devices division at MHRA. She has overall responsibility for the conduct and outcome of biological safety assessments undertaken for clinical investigation notifications submitted to the UK medical device competent authority.

Sophie Clewlow, Biocompatibility Specialist

Sophie is a biocompatibility specialist working as part of the biological safety team under the devices division at the Medicines and Healthcare products Regulatory Agency (MHRA). She is responsible for assessing biological safety evaluations and toxicological risk assessments according to ISO 10993 and the regulations.

David Jones, Expert Pharmaco-Toxicologist

David is an expert pharmaco-toxicologist within the licensing division of the Medicines and Healthcare products Regulatory Agency (MHRA). His current role principally involves assessing nonclinical data for Clinical Trial Authorisation (CTA) Applications and Marketing Authorisation Applications (MAA).

The material presented in this webinar has not been peer-reviewed. Any opinions are the presenter's own and do not necessarily represent those of IChemE or the Safety and Loss Prevention Special Interest Group. The information is given in good faith but without any liability on the part of IChemE.

Format

A one-hour online session: two 20 minute presentations + 20 minutes' Q&A.