Impurities MasterClass - EU edition
18-19 November, 2024
Current developments for impurities in small molecule APIs and respective medicinal products
Impurities are on the move, applicants and marketing authorization holders need to anticipate potential impurities and to subsequently identify, specify and qualify respective compounds.
18-19 November, 2024, 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
Testimonial
Our success stories
"High attention to detail in course content and very well delivered"
Simon Halsey
Product Development Manager
Essentra Packaging
United Kingdom
Our success stories
"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"
Aurelie Vivicorsi
USP PD Team Manager
Celonic AG
Switzerland
Our success stories
"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"
Emilia Szwej
Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany
About GLC
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