The Pharma 4.0 digital transformation is here and it’s happening now. Many Biopharmaceutical companies have embarked on Pharma 4.0 and are progressing well in their digital transformation journey. This digital transformation allows the Pharma industry to shape the future, as well as gain and sustain competitiveness in time. It allows the organization to fully live up to their accountability and operate with autonomy and command of the products. It goes hand in hand with the increasing digital maturity, being closer to the business to accelerate value creation and to be a competitive advantage to the company. Digital transformation starts as a trickle... ...and builds to a flood This presentation will focus on the Pharma 4.0 holistic approach within Merck Healthcare and will discuss the structured approach which is built around three dimensions: 1- Set the aspiration 2- Deliver higher priorities use cases and 3- Sustain it. But business drivers and logic are sterile if we do not embed the required mindset and behaviours in the organization. Therefore a particular emphasis will be placed on the culture and people involved. The talk will place emphasis on creating a culture of caring, pioneering and outperforming ‘where people are the success factor’ will be game changers in the external environment on the successful digital transformation. There is no magic bullet for successful digital transformation, and it won’t happen overnight. But there are best practices and there are ways to create conditions for success. Fostering a digital impact driven culture and driving people development are key to ensure replicable success.

In the next decade, we will experience more progress than in the past 100 years combined, as technology reshapes health and material sciences, energy, transportation and a wide range of other industries and domains. There are broad implications for industry. We will bring some of the results into our research on what matters. We will take about technologies that fuel the 4th industrial revolution as well as the impact from the upcoming bio revolution.

The scope of this session if to make you aware about what a CEO/COO need to know to help your company to keep plants more secure about cyber risk. After a brief introduction on the importance to protect system and networks at the Plant Level, presenting risks and threats to be faced, we'll speak about what to do and don't especially in real-life for Pharma 4.0 environment in order to implement a correct Cyber Security posture and hygene program to be ready to prevent cyber incidents that could affect data integrity, product quality, operation continuity, sustainability and compliance. We'll present also the outcome of the Italian ISPE/GAMP CyberSecurity Working Group: a self assessment tool developped to understand the company posture about the Cyber Security, in order to address the cyber risk, attribute priorities, drive management in the direction of a remediation plan and calculate a sustainable budget for required activities.

This keynote address will provide insights into some of the initiatives taken by the Office of Quality Surveillance (OQS) within the Office of Pharmaceutical Quality (OPQ), on enhancing an overall proactive quality surveillance framework through the integration of advanced analytics for assessing Pharmaceutical Quality System (PQS) effectiveness, Post-Market Quality Signal Detection, Quality Metrics (QM), and Quality Management Maturity (QMM), covering the latest program updates and implementations for advancing and modernizing quality surveillance.