Impurities - EU edition MasterClass

This topic is covered by the ICH M7 guideline which a harmonised practical framework that is applicable to the identification, categorisation, qualification, and control of these mutagenic impurities to limit potential carcinogenic risk.

13-14 February, 2023, Virtual

Time Zone: UTC/GMT+1 /CET

Overview

Impurities in small molecule active ingredients, excipients, medicinal products and packaging materials are important attributes in the assessment of quality and safety of medicinal products - this applies to all phases of the product life cycle. Not least the contamination by nitrosamines has changed regulators view of the subject and today we have to deal with the subject more intensively. Impurities are “on the move”, applicants and marketing authorization holders need to anticipate potential impurities and to subsequently identify, specify and qualify respective compounds. This applies to projects with new products, but also to specific occasions, such as the renewal of marketing authorisations, the sourcing of new active substances and excipients, changes in production and site transfers.

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RECOMMENDATION

Who should attend?

• People in charge for development of synthesis and control strategy for small molecule APIs

• People in charge for pharmaceutical development and control of medicinal products

• Regulatory Affairs Personnel

• Heads of quality control

• EU Qualified Persons