We have been notified that ISPE has postponed the 2020 ISPE Europe Annual Conference. If you were scheduled to meet with our team at the conference, someone will be in touch with you to determine if you’d like to proceed with a virtual discussion. Please contact [email protected] with any questions.
THE ROADMAP TO SUCCESS: Quality, Facility Design, Construction, Pharma 4.0, & Operational Excellence
For the first time, the 2020 ISPE Europe Annual Conference will introduce a Regulatory Panel as a plenary session. The panel will represent regulators from various countries and will address thought-provoking questions such as:
- How will new product design change regulatory oversight? What is the impact of personalised medicine, small batches, small products, continuous manufacturing, and extreme short shelf life products, for example gene and cell therapy, on the classical principles of quality oversight by regulators and manufacturers?
- What are the up- and downsides of the harmonisation for pharmaceutical GMP rules between FDA, EMA, TGA, PIC/S, and non-PIC/S members? What is the role of pharmacopoeias in this context?
- What is the major impact of new regulations on drug manufacturing, e.g., Annex 1, Annex 2, ICH Q 13, and new FDA draft guidance? How could Real Time Release Testing support release of ATMP with a very short shelf life?
Visit us at table 74 and see how we can support your programs and expedite your time to market. If you’d like to request a face-to-face meeting with our team, contact [email protected].