Nitrosamines Analysis (Step 2): Confirmatory testing

Authorities expects from all manufacturers to prevent or reduce the presence of nitrosamines in active pharmaceutical ingredients (APIs) and drug products.

On March 31st, 2021, the EMA guidance for Marketing Authorization Holders will engage a new milestone, called Step 2, and related to the process of products identified to be at risk of N-nitrosamine formation.

To give you all decision factors on the confirmatory testing, Eurofins BioPharma Product Testing and Waters are glad to invite you to this joined webinar, going through the latest regulatory requirements for testing nitrosamines in solvents, drug substance and drug products.

• Eurofins’ scientists will provide examples of screening methods performed in their facility located in Toulouse, France.

• Waters will explain how critical it is to combine both LC and MS aspects to quantify traces in highly concentrated matrices.

Presenter: Elodie Barrau (Site Manager, Eurofins Amatsi Analytics France)

Elodie Barrau is the Site Manager of Eurofins Amatsi Analytics in Toulouse area, France, with focus in chemistry, manufacturing and control, scientific support (GLP and GMP) for international preclinical, pharma, clinical development and/or registration, and implementation of analytical analysis. Elodie has a degree in Agronomist Engineering specialising in Phytochemistry Drug Development.

Presenter: Emmanuel Desmartin (Mass Spec and Bioanalysis Manager, Eurofins Amatsi Analytics France)

Emmanuel Desmartin is Mass Spec and Bioanalysis Lab Manager at Eurofins Amatsi Analytics, with 15 years of experience in bioanalysis; holding different positions in CROs as study director in development and validation of LC-MS methods, management of mass spec lab, and technical support.

Presenter: Arjan Timmerman (Pharmaceutical Marketing Manager EMEA Pharma, Compliance and Impurities, Waters European Head Quarters)

Arjan Timmerman, Experienced Pharmaceutical Marketing Manager with a demonstrated history of working in Regulated Pharmaceutical Industry, is skilled in Life Sciences, Impurities, Compliance and Data Integrity, Method Development and Validation.