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Formazione >> Webinar e Formazione Online >> Pharmaceutical impurities: Regulatory updates and challenges from a toxicologist point of view

Pharmaceutical impurities: Regulatory updates and challenges from a toxicologist point of view

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FREE ONLINE WEBINAR: To continue supporting our customers' needs this webinar is dedicated to manufacturers only. To allow all interested companies attend, maximum two delegates form the same company will be admitted. Due to the type of event and limited audience capacity, participation of companies not included in this category will not be accepted. Attendance will be confirmed from the event's organizers.

DATE: September 27, 2023 | 3.00 PM - 4.00 PM CET

OFFICIAL LANGUAGE: English

SUBMISSION LINK: https://register.gotowebinar.com/register/3950970123174384990

ATTENDEES CAPACITY: 500 delegates

Introduction

Impurity profiling is mandatory in the manufacturing process of pharmaceutical products. The presence of impurities could affect the quality and safety of drug products posing health risks to patients due to their potentially carcinogenic or immunogenic effects. The large number and variety of potential impurities presents a significant analytical challenge for their detection, quantification, and characterization.

The webinar aims to provide an overview of the regulatory framework related to the impurities in pharmaceutical products and the latest updates in the field of Extractables & Leachables and Nitrosamines.

These topics will be addressed from the perspective of the toxicologist, who has the delicate responsibility of assessing the toxicity of these impurities and, therefore, the safety of the pharmaceutical product.

The main focus will be the management of the laboratory output and how to deal with the challenges of assessing impurities.

Speaker

Eleonora Lostaglio, graduated in Toxicology and Safety Assessment in Milan, joined Eurofins BioPharma Product Testing Italy in 2020 after experiences in In silico Toxicology Research and in the Pharmaceutical industry as Quality Assurance. She currently works as Toxicologist and Project Manager in the consultancy team with major focus on Pharmaceutical area.