4th Annual Pharmaceutical
Regulatory Affairs
Summit

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Past Speakers

SEE THE PREVIOUS SPEAKERS & CASE STUDIES

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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:

Tim Powell

Director, Regulatory Submission Sciences

CASE STUDY

Exploring the Intersection of eCTD and IDMP

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.

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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.

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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.

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.

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Tim Powell

Director, Regulatory Submission Sciences

CASE STUDY

Exploring the Intersection of eCTD and IDMP

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.

Ahmed Nasr

Operations Director Egypt and Director Milk Africa & Turkey

Khaled Elsharkawy

Integrated Supply Chain Senior Director

Mueen Uddin Siddique

Senior Director – Access Network Procurement

Shannon Hore

Senior Vice President Procurement and Logistics

Sandeep Sharma

Director Group Procurement & International Markets Supply Chain

Hottest topics

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Testimonials

What our users say about our conferences

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I really enjoyed the programme and different speakers I had opportunity to hear.
Bayer
Head Regulatory Affairs Radiology Medical Devices EMEA
I really enjoyed learning from highly relevant presentations and lively discussions, and I will be definitely very happy to join the summit next year.
Merck
Associate Director Global Regulatory Affairs, Translational Medicine & Devices
It was a great conference and I was also very impressed with the topics and presentations.
Alexion Pharmaceuticals
Executive Director, International Regulatory Affairs
Informative, has great content, friendly, open. The size of the conference is ideal - wared as a group.
Gedeon Richter PLC
Head of Global Regulatory CMC & Operation Department
I really enjoyed the programme and different speakers I had opportunity to hear.
Bayer
Head Regulatory Affairs Radiology Medical Devices EMEA
I really enjoyed learning from highly relevant presentations and lively discussions, and I will be definitely very happy to join the summit next year.
Merck
Associate Director Global Regulatory Affairs, Translational Medicine & Devices
It was a great conference and I was also very impressed with the topics and presentations.
Alexion Pharmaceuticals
Executive Director, International Regulatory Affairs
Informative, has great content, friendly, open. The size of the conference is ideal - wared as a group.
Gedeon Richter PLC
Head of Global Regulatory CMC & Operation Department

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