Panel Discussion
Monday, September 25
06:10 PM - 07:10 PM
Live in Berlin
Less Details
New classes of biological medicines, new modalities and new industry pressures such as C&G therapy, small-scale, low-cost manufacturing plants, and continuous processing require a straight shift in biomanufacturing processes. If Pharma MES is located at the core of the Factory of the Future the industry needs to digitize and automate processes further and rely on the use of new technologies. Whereas i.e., C&G therapy is pushing digitalization and leads to new production IT strategies, current MES solutions are not as flexible, agile, and open as they need to be. So far, the pharmaceutical industry has not agreed on a common position but within the industry the movement from monolithic solutions to MES platform is visible.
We discuss:
Leading Sanofi manufacturing sites journey to digital as part of MARS (Manufacturing Execution System Accelerated Roadmap for Sanofi) program.
Registered pharmacist. Experienced in Quality Assurance (QA) and Regulatory Affairs (RA) fields in pharmaceutical and biotech industry.
Specialties:
- Design, implementation and control of Quality Management Systems
- Quality and regulatory compliance in pharmaceutical industry
- Audits and self-inspections
- Regulatory processes in pharmaceutical industry including compiling, submissions and other disciplines in products life cycle management
- Regulatory intelligence
Rebecca Nørgaard has been working at Novo Nordisk since 2009 as a Solution Architect for the organization's largest-ever IT program, implementing SAP and PAS-X MES systems in 30+ production sites. Presently, she holds the position of System Architect in the Novo Nordisk MES programme CoE, where she is responsible for the scoping and harmonization of NextGen PAS-X MES 3.3. With an IT degree from Novo Group and a graduation from Copenhagen Business School, Rebecca looks back on over 15 years of experience in supply chain ERP and MES systems.
Jane is the primary IT partner for the leadership team at Janssen Schaffhausen, with overall accountability of plant technology product roadmap, portfolio and investment strategy, aligned to Business Segment and IT strategy. She drives digital maturity, technology standardisation and cybersecurity across sites within the segment, and ensures effective delivery of digital capabilities.
Prior to taking her current role with the manufacturing site, Jane was the Global J&J MES PAS-X Product Owner for J&J, responsible for building the vision and strategy for the Manufacturing Execution System (MES) used within Janssen Supply Chain Pharma and Consumer Sectors. She was responsible for the full lifecycle of MES at sites using regional, local and vendor teams, from development, planning and delivery through to support and maintenance of the system.
Pop in my Job
“We believe our first responsibility is to the patients” is the core of the Johnson and Johnson Credo. I’m driven by constantly improving the supply chain for patient care products through technology. Enabling Right-First-Time, real time release, innovation and flexibility in the supply chain inspires me every day.