2020 ISPE Europe Annual Conference
THE ROADMAP TO SUCCESS: Quality, Facility Design, Construction, Pharma 4.0, & Operational Excellence
The theme for the 2020 ISPE Europe Annual Conference will be the “The Roadmap to Success” with an Executive Forum, dynamic plenary speakers, four robust tracks and cutting-edge plant tours.
The tracks will focus on:
- Track 1: Facilities of the Future - Continuous manufacturing for oral solids and biotech; aseptic processing new improvements and technical innovations
- Track 2: Pharma 4.0 – what is the way to implement the new operating model with industry cases, application of maturity models, digitisation, self-learning devices, plug and produce and a holistic control strategy
- Track 3: Quality - validation, Annex 1, Annex 2, ICH Q13 and the FDA’s continuous manufacturing draft guidance, Annex 17 real time release testing and continuous verification
- Track 4: New Trends in CQV and Impact on Project, GAMP® Delivery – small molecules, API, biopharmaceutical operations, key controls for being more flexible, more agile, more adaptive to changing product portfolio
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 by 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- What is the major impact of new regulations on drug manufacturing, e.g. Annex 1, Annex 2, ICH Q 13 and new FDA draft guidance?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?