Date: 12 November 2019 - 13 November 2019
Crowne Plaza Düsseldorf – Neuss
For the seventh time, with conferences and the exhibition, PharmaLab, offers the opportunity to keep up to date with the latest regulatory changes and developments in science and technology for pharmaceutical quality control (QC) and quality assurance (QA) laboratories.
In 2018, there were a number of regulations that kept QC and QA experts busy.
For cell- and tissue-based products, the GMP for ATMP Guideline was followed by further drafts, e.g. the EMA guidelines “GCP for ATMP” and “Safety and Efficacy
Follow-up and Risk Management of ATMPs.” Further, the ongoing changes in analytics and bioanalytics also affect manufacturers and laboratories. ICH Q14
“Analytical Procedure Development and Revision of Q2(R1) Analytical Validation” or the ICH M10 Draft Guideline “Validation of Bioanalytical Methods” require the attention of the persons responsible for quality.
There are also developments with regard to microbiological tests that need to be considered, e.g. – owing the EU regulations on the reduction of animal experiments – pyrogen testing with Monocyte Activation Tests (MAT) instead of rabbit tests. However, rapid methods – especially for biopharmaceuticals and ATMPs – have also been advanced and, thus, attract the attention of the authorities. Environmental monitoring is currently characterised by the increasing number of systems for real-time or online testing of air, water, and surfaces. This enables a more complete recording of the microorganisms present.
These and other topics, from Data Integrity to Low Endotoxin Recovery (LER), will be presented in detail in five parallel conference sessions and a pre-conference workshop. Together with the exhibition, PharmaLab offers the unique opportunity to learn about the latest developments, to discuss them with experienced colleagues, and to benefit from the experience of about 60 speakers.