The Digital Transformation Journey is one of the most important strategic challenges in today’s pharma organisations. The maturity of the Business Processes and the Pharmaceutical Quality System are prerequisites for moving into digital operations. Digital transformation is a holistic approach to move from paper to electronic workflow-based end-to-end operations along the value chain. Key challenges of the transformation include: Integration, cultural change, data availability, and strategic ownership based on practical case studies.

With ISPE’s GAMP 5 2nd Edition providing a substantial amount of new and updated content, we welcome insights into: Computer Software Assurance, Data Integrity, Artificial Intelligence and Agile Software Development

Good Engineering Practice (GEP) is combination of standards, specifications, codes, regulatory and industrial guidelines as well as accepted engineering and design methods intended to design, construct, operate, and maintain pharmaceutical and/or biotechnology facilities that encompass regulatory compliance, safety, economics, environmental protection and operability. This focus area will be inspecting the transformation of engineering and project delivery in a digitalised world.

Applying harmonised approaches to innovative design solutions and project delivery strategies to ensure quality therapeutic products are brought to market in an efficient manner. Submissions addressing these topics may include: Digitalised & Aseptic case studies and presentations on the digital applications of aseptic requirements such as contamination control strategies, aseptic GMP requirements, etc.; Fully Contained—closed systems case studies and technologies and their use in pharmaceutical manufacturing, and the role of Contract Manufacturing in repatriation of API and medicines production.

The impact and potential utilisation of new technologies, processes, and disruptions on operations and logistics of the production of all types of therapies. Submissions may address supply chain shortages; the conditions that would encourage pharmaceutical manufacturing across Asia, and the requirements for capabilities and skillsets needed for the workforce of the future.

Regulatory and quality challenges, learnings, and opportunities which might include the current speed to market expectations, pandemic management, drug shortages, and the regulatory focus on data integrity.

Emerging and evolving technologies and practices that are helping drive a revolution in medicinal therapies, analytical techniques, manufacturing paradigms, medical devices including novel methods to deliver the next generation of drugs to patients.