Pharma 4.0 Business Foundations and Implementation Approaches
ISPE will continue the series of successful, annual Pharma 4.0 Conferences, but this year in a virtual format.
The focus of the 2020 ISPE Pharma 4.0™ Virtual Conference will be on practical examples of implemented business cases and Lighthouse projects based on the Pharma 4.0 operating model, developed by the ISPE Special Interest Group Working teams, which conduct interactive discussion sessions for all attendees during the conference.
ISPE has endorsed a true Pharma 4.0 culture from inception, a culture that enables effective and “smart” working. The COVID-19 pandemic emphasised this impact on our future business environment and imminent workways. Executives and Experts will address this in the keynote presentations.
Very often the questions; what the definition of Pharma 4.0 is, where do we start with it, what does it require as an investment and what is the pay-off, are raised. During the conference you will have the opportunity to listen, question and absorb the following statements, that is a direct response to the questions and are based on an industrial approach, triggered and driven by digitalisation and the new opportunities for big data management.
Statements on Pharma 4.0:
Pharma 4.0 extends/describes the Industry 4.0 Operating Model for medicinal products.
In difference to common Industry 4.0 approaches, Pharma 4.0 embeds health regulations best practices.
Pharma 4.0 breaks silos in organisations by building bridges between industry, regulators and healthcare and all other stakeholders.
For the next Generation Medicinal Products, Pharma 4.0 is THE enabler and business case.
For the established products, Pharma 4.0 offers new business opportunities.
Investment calculations for Pharma 4.0 require innovative approaches for business case calculations.
Prerequisite for Pharma 4.0 is an established Pharma Quality Systems (PQS) and controlled processes and products.
Pharma 4.0 is not an IT project.
The Pharma 4.0 Operating Model incorporates, in addition to IT also the organisational, cultural, processes and resources aspects.
The Pharma 4.0 Maturity Model allows aligning the organisation’s operating model - for innovative and established industries, suppliers and contractor - to an appropriate desired state.
Pharma 4.0 is not a must, but a competitive advantage. Missing Pharma 4.0 increasingly becomes a business risk.
When moving from blockbusters to niche products and personalised medicines, Pharma 4.0 offers new ways to look at business situations.
What You Can Expect
Virtual Plant Tours
The programme also offers four interactive workshops, where the presentations of business cases and lighthouse projects will be discussed. Holistic Control Strategy and Maturity Levels, Equipment connectivity and Plug and Produce approaches, Batch release with One button and Communication Strategies to Management are some of the topics that will be examined during the workshops.
How a company can establish Pharma 4.0 concepts
How the positive impact of business cases can be measured and communicated
What the definition and scope of a holistic control strategy is and how it extends the ICH Guidelines Q8 and Q 10 and Q 12
What level of maturity should a computerised system landscape have in order to successfully operate in a digitalised world
What the conditions and premises for maturity levels such as computerisation, connectivity, transparency, visibility, predictability and adaptability are.
Where to find the optimum between investment expenditure and achievement of business strategy goals
How to pitch, shape, estimate and kick-off a Pharma 4.0 project.