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

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Key learnings

Regulatory Requirements

Detailed insights regarding the regulatory requirements in Europe

Medicinal Products

Current developments related to the assessment for potential impurities in medicinal products

Overview

Overview regarding different approaches for establishment of control strategies for impurities in APIs and medicinal products

Impurities

Awareness for risk assessments to be performed in the field of impurities

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Pharma Online Masterclass

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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Trainer

Dr. Ralph Nussbaum

Head of Quality
Omega Pharma

Dr. Ralph Nussbaum has been Vice President Quality Management and Managing Director, Member of the Board at Auregen BioTherapeutics GmbH in Reutlingen since 2020. Dr. Ralph Nussbaum was Market Segment Leader Pharma and Site Manager at SYNLAB Analytics & Services Germany GmbH in Aachen from 2017 to 2020. Dr. Ralph Nussbaum is a chemist and worked in quality control at Gruenenthal GmbH. He gained further professional experience at CarboGen Laboratories AG as Manager Quality Assurance. From 2003 to 2017, he was Managing Director of Analytical Services.

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Reasons to attend a masterclass

Practical knowledge

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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

Ticket options for you

Full event
pass

Team participation?

*minimum of 10 participants

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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

Global Leadership Conferences began as an ambitious dream by three founders ten years ago. Today its an international series of interactive events, exploring the hottest topics in critical fields. Each year, thousands of professionals join us to challenge the status quo and learn innovative ways to create new solutions in Finance, Pharmaceutical, HR, Health & Safety, and Energy.

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