4th Annual Pharmaceutical
Regulatory Affairs Summit
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Past Speakers
SEE THE PREVIOUS SPEAKERS & CASE STUDIES
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.
- 01Data Governance roles & responsibilities
- 02Affiliate activities
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.
- 01Global submission
- 02Regulatory strategy
- 03EMA, FDA, PMDA
- 04Innovation
- 05Regulatory flexibility
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.
- 01Learn and understand Sustainable Regulatory Framework definition
- 02Discuss regulatory and legal enablers to “move the dial” of harmonisation and convergence to achieve this framework for International markets
- 03Discuss how the future could look like adopting a blue ocean strategic thinking
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:
- 01How regulatory submissions are evolving and the need for new systems and tools
- 02The importance of an integrated approach to digital transformation
- 03A Roche use case of digital transformation in Regulatory Operations
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.
- 01Where do eCTD and IDMP meet?
- 02How could increasing submission of product data impact the content of eCTD dossiers?
- 03What opportunities are there to streamline and work efficiently in the future?
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.
- 01Data Governance roles & responsibilities
- 02Affiliate activities
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.
- 01Global submission
- 02Regulatory strategy
- 03EMA, FDA, PMDA
- 04Innovation
- 05Regulatory flexibility
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:
- 01How regulatory submissions are evolving and the need for new systems and tools
- 02The importance of an integrated approach to digital transformation
- 03A Roche use case of digital transformation in Regulatory Operations
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.
- 01Learn and understand Sustainable Regulatory Framework definition
- 02Discuss regulatory and legal enablers to “move the dial” of harmonisation and convergence to achieve this framework for International markets
- 03Discuss how the future could look like adopting a blue ocean strategic thinking
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.
- 01Where do eCTD and IDMP meet?
- 02How could increasing submission of product data impact the content of eCTD dossiers?
- 03What opportunities are there to streamline and work efficiently in the future?
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.
- 01Data Governance roles & responsibilities
- 02Affiliate activities
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.
- 01Global submission
- 02Regulatory strategy
- 03EMA, FDA, PMDA
- 04Innovation
- 05Regulatory flexibility
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:
- 01How regulatory submissions are evolving and the need for new systems and tools
- 02The importance of an integrated approach to digital transformation
- 03A Roche use case of digital transformation in Regulatory Operations
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.
- 01Learn and understand Sustainable Regulatory Framework definition
- 02Discuss regulatory and legal enablers to “move the dial” of harmonisation and convergence to achieve this framework for International markets
- 03Discuss how the future could look like adopting a blue ocean strategic thinking
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.
- 01Where do eCTD and IDMP meet?
- 02How could increasing submission of product data impact the content of eCTD dossiers?
- 03What opportunities are there to streamline and work efficiently in the future?
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
LOOK AT THE TOPICS THAT WERE DISCUSSED
- 01 Digitalisation in Regulatory Submissions: The latest trends in electronic submissions (eSubmissions) and the shift towards paperless regulatory processes
- 02Data integrity and security: Challenges in ensuring data integrity and security in the digital regulatory environment and the way to solve it
- 03How are regulatory affairs shaping the development of cutting-edge pharma innovation?
- 04Exploring AI’s Impact on Drug Regulation and Approval
- 05Regulatory framework for emerging technologies: Developing a robust regulatory framework that accommodates emerging technologies, such as AI, digital health, and advanced manufacturing
Testimonials
What our users say about our conferences
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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