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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:
The eCTD and IDMP realms were created separately at different points in history and had no intentional overlap; however, in reality, there are significant similarities in the data/metadata submitted in each. We will explore the intersections in detail and look at potential future improvements.
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.
The eCTD and IDMP realms were created separately at different points in history and had no intentional overlap; however, in reality, there are significant similarities in the data/metadata submitted in each. We will explore the intersections in detail and look at potential future improvements.
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.
The eCTD and IDMP realms were created separately at different points in history and had no intentional overlap; however, in reality, there are significant similarities in the data/metadata submitted in each. We will explore the intersections in detail and look at potential future improvements.
Operations Director Egypt and Director Milk Africa & Turkey
Integrated Supply Chain Senior Director
Senior Director – Access Network Procurement
Senior Vice President Procurement and Logistics
Director Group Procurement & International Markets Supply Chain
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