Sample of Keynote Speakers and their Case Studies
Global Internal Benchmark for key HR Metrics. Key HR Metrics are aggregated and shared globally between different regions so each region can compare their own results with others within Sony. This is a good use case of how own data is utilised and leveraged in a global scale.
Global Internal Benchmark for key HR Metrics. Key HR Metrics are aggregated and shared globally between different regions so each region can compare their own results with others within Sony. This is a good use case of how own data is utilised and leveraged in a global scale.
Global Internal Benchmark for key HR Metrics. Key HR Metrics are aggregated and shared globally between different regions so each region can compare their own results with others within Sony. This is a good use case of how own data is utilised and leveraged in a global scale.
VP Regulatory Affairs, Established Markets and Global Regulatory Operations
The Regulatory Affairs department will have to navigate various external changes continuously. In this presentation, we will review the impact of the transition from Dossier-focused submissions towards Data-driven submissions and what that means to the Regulatory Data Governance. Furthermore, we will take a look at the impact of typical Pharma industry changes on the activities in the Affiliate RA teams.
In this session, we will discuss options for navigating Global Regulatory Landscape Changes to ensure innovative medicine reaches patients globally in a timely manner. We will also be looking at efficient ways to meet global regulatory requirements for therapies for unmet medical needs.
Regulatory Policy and Intelligence Director — International Region & China
The recent pandemic surfaced new challenges and opportunities for regulatory environments to innovate. One key realisation was that to innovate in “critical” situations like a pandemic, regulatory systems must be sustainable and agile, developing an armoury of regulatory processes ranging from reliance to independent review — which could be selected based on healthcare priority, capacity, capability, timings and patient need. This armoury of regulatory processes will contain a toolkit of standard, accelerated and adaptive pathways to Marketing Authorisation incorporating worksharing,
reliance and collaborative frameworks in each country’s system.
This presentation will highlight how regulatory submissions are changing due to advances in science, data and technology. The application of new technologies, in particular RPA, genAI and cloud platforms, to accelerate submissions will be discussed as well as the need for an integrated approach to digital transformation. Lessons learned from digital transformation in Regulatory Operations will be shared as a practical use case.
This presentation will cover:
In the ever-changing regulatory framework, we cannot ignore the international reliance procedures such as ORBIS, ACCESS, OPEN and others, which become increasingly important in defining regulatory strategies. Internal adaptations are needed to respond to those external developments. The presentation will cover the experiences, opportunities seen and challenges dealt with using these procedures.
VP Regulatory Affairs, Established Markets and Global Regulatory Operations
The Regulatory Affairs department will have to navigate various external changes continuously. In this presentation, we will review the impact of the transition from Dossier-focused submissions towards Data-driven submissions and what that means to the Regulatory Data Governance. Furthermore, we will take a look at the impact of typical Pharma industry changes on the activities in the Affiliate RA teams.
In this session, we will discuss options for navigating Global Regulatory Landscape Changes to ensure innovative medicine reaches patients globally in a timely manner. We will also be looking at efficient ways to meet global regulatory requirements for therapies for unmet medical needs.
In the ever-changing regulatory framework, we cannot ignore the international reliance procedures such as ORBIS, ACCESS, OPEN and others, which become increasingly important in defining regulatory strategies. Internal adaptations are needed to respond to those external developments. The presentation will cover the experiences, opportunities seen and challenges dealt with using these procedures.
This presentation will highlight how regulatory submissions are changing due to advances in science, data and technology. The application of new technologies, in particular RPA, genAI and cloud platforms, to accelerate submissions will be discussed as well as the need for an integrated approach to digital transformation. Lessons learned from digital transformation in Regulatory Operations will be shared as a practical use case.
This presentation will cover:
Regulatory Policy and Intelligence Director — International Region & China
The recent pandemic surfaced new challenges and opportunities for regulatory environments to innovate. One key realisation was that to innovate in “critical” situations like a pandemic, regulatory systems must be sustainable and agile, developing an armoury of regulatory processes ranging from reliance to independent review — which could be selected based on healthcare priority, capacity, capability, timings and patient need. This armoury of regulatory processes will contain a toolkit of standard, accelerated and adaptive pathways to Marketing Authorisation incorporating worksharing,
reliance and collaborative frameworks in each country’s system.
VP Regulatory Affairs, Established Markets and Global Regulatory Operations
The Regulatory Affairs department will have to navigate various external changes continuously. In this presentation, we will review the impact of the transition from Dossier-focused submissions towards Data-driven submissions and what that means to the Regulatory Data Governance. Furthermore, we will take a look at the impact of typical Pharma industry changes on the activities in the Affiliate RA teams.
In this session, we will discuss options for navigating Global Regulatory Landscape Changes to ensure innovative medicine reaches patients globally in a timely manner. We will also be looking at efficient ways to meet global regulatory requirements for therapies for unmet medical needs.
This presentation will highlight how regulatory submissions are changing due to advances in science, data and technology. The application of new technologies, in particular RPA, genAI and cloud platforms, to accelerate submissions will be discussed as well as the need for an integrated approach to digital transformation. Lessons learned from digital transformation in Regulatory Operations will be shared as a practical use case.
This presentation will cover:
Regulatory Policy and Intelligence Director — International Region & China
The recent pandemic surfaced new challenges and opportunities for regulatory environments to innovate. One key realisation was that to innovate in “critical” situations like a pandemic, regulatory systems must be sustainable and agile, developing an armoury of regulatory processes ranging from reliance to independent review — which could be selected based on healthcare priority, capacity, capability, timings and patient need. This armoury of regulatory processes will contain a toolkit of standard, accelerated and adaptive pathways to Marketing Authorisation incorporating worksharing,
reliance and collaborative frameworks in each country’s system.
In the ever-changing regulatory framework, we cannot ignore the international reliance procedures such as ORBIS, ACCESS, OPEN and others, which become increasingly important in defining regulatory strategies. Internal adaptations are needed to respond to those external developments. The presentation will cover the experiences, opportunities seen and challenges dealt with using these procedures.