Speakers

Sample of Keynote Speakers and their Case Studies

Quentin Descat

Head Global Cardiovascular – Commercial Launch Brands Lead

CASE STUDY

The Employer Experience Proposition

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.

Quentin Descat

Head Global Cardiovascular – Commercial Launch Brands Lead

CASE STUDY

The Employer Experience Proposition

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.

Quentin Descat

Head Global Cardiovascular – Commercial Launch Brands Lead

CASE STUDY

The Employer Experience Proposition

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.

Слайдшоу

Anne Marie Jonker-Huisman

VP Regulatory Affairs, Established Markets and Global Regulatory Operations

CASE STUDY

How External Trends Impact Operational Activities in Regulatory Affairs

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.

Martine Zimmermann

SVP, Head of Regulatory & R&D Quality

CASE STUDY

Navigating Global Regulatory Landscape Changes: Strategies for Accelerating Submission

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.

Anna Litsiou

Regulatory Policy and Intelligence Director — International Region & China

CASE STUDY

Sustainable Regulatory Framework: A Toolkit of Regulatory Processes and Tools to Enable Patient Access and Foster Innovation

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.

Helena Corte-Real Correia

VP Regulatory Portfolio Data and Content Lead

CASE STUDY

Digitalisation in Regulatory Submissions — The Latest Trends

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:

Ann Emmerechts

Executive Director Global Regulatory Sciences International, ACO Group Lead

CASE STUDY

Global Regulatory Strategies — Navigating the Challenges and Opportunities of International Reliance Procedures (Such as Orbis, Access...)

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.

Thumbnail 1
Thumbnail 2
Thumbnail 3
Thumbnail 4
Thumbnail 5
88

Anne Marie Jonker-Huisman

VP Regulatory Affairs, Established Markets and Global Regulatory Operations

CASE STUDY

How External Trends Impact Operational Activities in Regulatory Affairs

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.

44

Martine Zimmermann

SVP, Head of Regulatory & R&D Quality

CASE STUDY

Navigating Global Regulatory Landscape Changes: Strategies for Accelerating Submission

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.

1010

Ann Emmerechts

Executive Director Global Regulatory Sciences International, ACO Group Lead

CASE STUDY

Global Regulatory Strategies — Navigating the Challenges and Opportunities of International Reliance Procedures (Such as Orbis, Access...)

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.

1111

Helena Corte-Real Correia

VP Regulatory Portfolio Data and Content Lead

CASE STUDY

Digitalisation in Regulatory Submissions — The Latest Trends

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:

77

Anna Litsiou

Regulatory Policy and Intelligence Director — International Region & China

CASE STUDY

Sustainable Regulatory Framework: A Toolkit of Regulatory Processes and Tools to Enable Patient Access and Foster Innovation

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.