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 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What is the major impact of new regulations on drug manufacturing, e.g. Annex 1, Annex 2, ICH Q 13 and new FDA draft guidance?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?

Learning Objectives

Recognise ways of working that relates to how industry work to meet current and proposed regulatory requirements
Learn through case studies how modern engineering and project delivery drive project managers and engineers to adapt their practices to ensure consistent continuity and successful projects
Follow case studies on innovation in factories of the future, continuous manufacturing concepts and production
Gain insight in a new world of pharmaceutical manufacturing
Learn how to apply a holistic view on manufacturing strategies of the future
Understand the operating model applied with Pharma 4.0
Get a feeling about readiness qualifiers for industry
Have dialogues with the peer groups and with senior industry leaders on these hot topic

The 2020 ISPE Europe Annual Conference has four tracks focusing 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Track 3: Quality – validation, Annex 1, Annex 2, ICH Q13 and the FDA’s continuous manufacturing draft guidance, Annex 17 real time release testing and continuous verification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 Delivery – small molecules, API, biopharmaceutical operations, key controls for being more flexible, more agile, more adaptive to changing product portfolio

View programme to learn more about the sessions in each of these tracks.

Who Should Attend?

Professionals at all levels of the pharmaceutical industry including:
Emerging Leaders
Senior Executives
Communities of Practice
Special Interest Groups
Equipment and Services Suppliers
Regulatory Professionals

Could we spark your interest?