Qepler | summits & conferences | Genotoxic Impurities in Pharmaceuticals Summit, 11-12 April 2019
Event Location:
Berlin, Germany
Venue:
To be announced
Date:
11 April 2019 - 12 April 2019
Language:
English

The call for speakers is open now.
Please find below the tentative schedule. Speaking sessions will be grouped according to similar themes into blocks and published upon finalizing the agenda, so please check back!

Contact Person: Evgenia Makar
Contact Person: Evgenia Makar, Qepler s.r.o.
Contact Person: Denis Polikarpov
Contact Person: Denis Polikarpov, Qepler s.r.o.

Conference Overview

For the transformation of starting material into the product is needed API synthesis, which involves multiple reaction steps, including reagents, intermediates, catalysts, solvents and others. As a result, low levels of by-products may appear in API as impurities. This impurity may have toxicity, incl. carcinogenicity and genotoxicity, what may cause mutations, potentially leading to cancer. Due to this fact and focusing on ensuring safety of public health is critical to identify, monitor, analyse and control genotoxic impurities and strive to their minimum level. This has led to the crucial need in the development and improvement of analytical methods.

The Genotoxic Impurities in Pharmaceuticals Summit 2019 is focusing on overcoming challenges and barriers, sharing knowledge, strategies, best techniques and new methodologies in GTI predictions, analysis and control during the drug development process, overview and practical implementation of GTI guidelines and regulations (ICH M7 and ICH Q3D), risk assessment, exposure limits calculation and predictions' empowerment through in silico.

Meet our Speakers

PREVIOUS EVENT

Networking

Harshal Shah

Cambridge Consultants

chaired a panel discussion on the digitisation of clinical trials and next gen injectable devices, with speakers from Novartis, Roche, Janssen, Sanofi, SHL Group and Corvus Device.