5th Annual Pharmaceutical
Regulatory Affairs Summit
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Past Speakers
SEE THE PREVIOUS SPEAKERS & CASE STUDIES
CASE STUDY
Artificial Intelligence and Digital Health Technologies Framework and Challenges
As a transformative tool, AI will soon span the full range of drug development activities – from discovery and preclinical testing to post-approval studies, pharmacovigilance, and manufacturing.
Having primarily begun in the EU, US, and China, AI and DHT policies are now evolving worldwide. However, different approaches to AI Governance between countries depend on cultural values and philosophies. We will try to give an overview of what these policies and frameworks are and the challenges we face in the coming years.
- 01Common pitfalls of Agile transformation — mistakes you could avoid
- 02Is Agile just a new way of working, or is there more — what did we miss?
- 03How can “digital documents” hinder and limit your digital transformation?
Payit is UAE’s first fully featured digital wallet. This presentation narrates the story of how a digital wallet transformed financial transactions for families and communities in the region into joyful moments by thoughtfully curating experiences centred around customers’ spending, sending, and borrowing moments, enabled by the comfort and convenience of digital. This led to the wider acceptance of Payit and an upsurge in usage and profitable revenues.
Stefano Accorsi
Senior Director, Global Regulatory Affairs Policy, Intelligence and Affiliates
CASE STUDY
The Evolving EU Pharmaceutical Regulations and Their Global Impact
In this presentation, we will see how the evolution of the regulatory environment in Europe (new pharmaceutical regulations and beyond) is going to change the way the pharmaceutical industry works, not only in this region.
- 01The evolution of the regulatory scenario in Europe (new Pharmaceutical Regulation)
- 02The impact of the new environment in this Region on the pharmaceutical industry
- 03The ‘butterfly effect’: How the change of regulations in Europe impacts other parts of the world
In today’s rapidly evolving digital landscape, the banking sector faces increasingly sophisticated cyber threats. As banks continue to innovate and expand their digital services, ensuring robust cybersecurity measures is more critical than ever. This presentation, titled “Evolving Cybersecurity in the Banking Sector: Strategies for Adapting to Emerging Threats,” will explore the latest trends in cyber threats, discuss effective strategies for mitigating risks, and highlight best practices for maintaining security in an ever-changing environment. Join us as we delve into the challenges and solutions that are shaping the future of cybersecurity in banking.
CASE STUDY
Ontologies – The Next Step in Managing Structured Regulatory Data
Traditionally, Regulatory Affairs relied on unstructured data that are maintained in documents. This is slowly but steadily changing as regulators demand the submission of structured data in addition to documents (e.g., XEVMPD and IDMP requirements). Being able to manage structured substance and product data will, in the future, be a prerequisite to further speed up the regulatory submission process and be a distinguishing factor in increasing development to market speed. Ontologies are a scalable approach to manage large quantities of regulatory data, break up data siloes and connect data even beyond regulatory requirements. We will dive into the world of ontologies to showcase how Regulatory Affairs can profit from this technological innovation.
- 01Structured data management in Regulatory Affairs – Status and future requirements
- 02How regulatory requirements foster technological innovation
- 03Ontologies and how they can help us to manage large volumes of structured data
- 04Defining data standards for substance and product data – The IDMP ontology
- 05Establishing the IDMP ontology as a data quality management tool
- 06Future of the IDMP ontology
mBank is the first bank in Europe provide customers with a full-featured e-commerce shopping experience, where they can buy millions of products from thousands of retailers without leaving the mobile app.
Why did we decide to take this step, and where do we see the success factors?
How, from the Bank’s perspective, we rely on our unique strengths: knowing our customers, their products and shopping needs? How can recommendations for specific categories and products support our customers in their shopping decisions?
CASE STUDY
Future Trends in Regulators Affairs: Data-Driven Submissions
A clear paradigm shift is underway, where data is taking precedence over traditional, document-based approaches. In my presentation, I will share practical examples illustrating the expanding role and significance of data and its profound impact on the regulatory landscape. This transformation is reshaping the field both internally, from a company perspective, and externally, from an authority perspective, as new opportunities and requirements emerge.
- 01Overview of the Part and how the regulatory submissions evolved
- 02EU landscape and upcoming requirements regarding data centralisation (IDMP, PLM Portal, eAF, reusability of the data and interoperability)
- 03FDA initiative, KASA modell, ICH M4Q(R2)
- 04Company response strategy initiatives (Data governance, SCA)
This presentation will provide an in-depth analysis of the financial industry’s transformation, from its traditional banking roots to the rise of fintech and the disruptive influence of Web3 technologies. By examining the historical context, key innovations, and future implications, we will gain a comprehensive understanding of how the financial landscape has been reshaped and what the future holds for the industry. Join me to understand finance’s past, present, and future in a rapidly changing digital world.
CASE STUDY
Global Partnership with Suppliers, Customers and Regulatory Bodies from API and FDF Manufacturer Perspective
Global collaboration between companies across the supply chain provides tremendous value to products brought to market, patient safety and understanding of evolving requirements. It allows for an increase in product quality, supports smooth registration processes and thus secures the time it takes to introduce the product to the market. A similar situation may also occur with cooperation with regulatory bodies; the exchange of knowledge and experience can only have a positive impact on product safety. As a person who has been supporting cooperation in the area of regulatory affairs for many years, I would like to show, based on examples, how many benefits it can bring.
- 01Cooperation with suppliers and customers during the introduction of a product on the market and further in the life cycle
- 02Cooperation with regulatory bodies during the registration process and new guidelines/requirements coming into force
- 03Challenges and benefits of the above presented based on examples
- 04Despite many challenges, global collaboration can have only benefits
In our presentation, we will talk about how to build a digital bank and digital banking environment in Turkey. What we had done while creating our brand, what we are doing and what are our next steps.
CASE STUDY
Artificial Intelligence and Digital Health Technologies Framework and Challenges
As a transformative tool, AI will soon span the full range of drug development activities – from discovery and preclinical testing to post-approval studies, pharmacovigilance, and manufacturing.
Having primarily begun in the EU, US, and China, AI and DHT policies are now evolving worldwide. However, different approaches to AI Governance between countries depend on cultural values and philosophies. We will try to give an overview of what these policies and frameworks are and the challenges we face in the coming years.
- 01Common pitfalls of Agile transformation — mistakes you could avoid
- 02Is Agile just a new way of working, or is there more — what did we miss?
- 03How can “digital documents” hinder and limit your digital transformation?
Payit is UAE’s first fully featured digital wallet. This presentation narrates the story of how a digital wallet transformed financial transactions for families and communities in the region into joyful moments by thoughtfully curating experiences centred around customers’ spending, sending, and borrowing moments, enabled by the comfort and convenience of digital. This led to the wider acceptance of Payit and an upsurge in usage and profitable revenues.
Stefano Accorsi
Senior Director, Global Regulatory Affairs Policy, Intelligence and Affiliates
CASE STUDY
The Evolving EU Pharmaceutical Regulations and Their Global Impact
In this presentation, we will see how the evolution of the regulatory environment in Europe (new pharmaceutical regulations and beyond) is going to change the way the pharmaceutical industry works, not only in this region.
- 01The evolution of the regulatory scenario in Europe (new Pharmaceutical Regulation)
- 02The impact of the new environment in this Region on the pharmaceutical industry
- 03The ‘butterfly effect’: How the change of regulations in Europe impacts other parts of the world
In today’s rapidly evolving digital landscape, the banking sector faces increasingly sophisticated cyber threats. As banks continue to innovate and expand their digital services, ensuring robust cybersecurity measures is more critical than ever. This presentation, titled “Evolving Cybersecurity in the Banking Sector: Strategies for Adapting to Emerging Threats,” will explore the latest trends in cyber threats, discuss effective strategies for mitigating risks, and highlight best practices for maintaining security in an ever-changing environment. Join us as we delve into the challenges and solutions that are shaping the future of cybersecurity in banking.
CASE STUDY
Ontologies – The Next Step in Managing Structured Regulatory Data
Traditionally, Regulatory Affairs relied on unstructured data that are maintained in documents. This is slowly but steadily changing as regulators demand the submission of structured data in addition to documents (e.g., XEVMPD and IDMP requirements). Being able to manage structured substance and product data will, in the future, be a prerequisite to further speed up the regulatory submission process and be a distinguishing factor in increasing development to market speed. Ontologies are a scalable approach to manage large quantities of regulatory data, break up data siloes and connect data even beyond regulatory requirements. We will dive into the world of ontologies to showcase how Regulatory Affairs can profit from this technological innovation.
- 01Structured data management in Regulatory Affairs – Status and future requirements
- 02How regulatory requirements foster technological innovation
- 03Ontologies and how they can help us to manage large volumes of structured data
- 04Defining data standards for substance and product data – The IDMP ontology
- 05Establishing the IDMP ontology as a data quality management tool
- 06Future of the IDMP ontology
mBank is the first bank in Europe provide customers with a full-featured e-commerce shopping experience, where they can buy millions of products from thousands of retailers without leaving the mobile app.
Why did we decide to take this step, and where do we see the success factors?
How, from the Bank’s perspective, we rely on our unique strengths: knowing our customers, their products and shopping needs? How can recommendations for specific categories and products support our customers in their shopping decisions?
CASE STUDY
Future Trends in Regulators Affairs: Data-Driven Submissions
A clear paradigm shift is underway, where data is taking precedence over traditional, document-based approaches. In my presentation, I will share practical examples illustrating the expanding role and significance of data and its profound impact on the regulatory landscape. This transformation is reshaping the field both internally, from a company perspective, and externally, from an authority perspective, as new opportunities and requirements emerge.
- 01Overview of the Part and how the regulatory submissions evolved
- 02EU landscape and upcoming requirements regarding data centralisation (IDMP, PLM Portal, eAF, reusability of the data and interoperability)
- 03FDA initiative, KASA modell, ICH M4Q(R2)
- 04Company response strategy initiatives (Data governance, SCA)
This presentation will provide an in-depth analysis of the financial industry’s transformation, from its traditional banking roots to the rise of fintech and the disruptive influence of Web3 technologies. By examining the historical context, key innovations, and future implications, we will gain a comprehensive understanding of how the financial landscape has been reshaped and what the future holds for the industry. Join me to understand finance’s past, present, and future in a rapidly changing digital world.
CASE STUDY
Global Partnership with Suppliers, Customers and Regulatory Bodies from API and FDF Manufacturer Perspective
Global collaboration between companies across the supply chain provides tremendous value to products brought to market, patient safety and understanding of evolving requirements. It allows for an increase in product quality, supports smooth registration processes and thus secures the time it takes to introduce the product to the market. A similar situation may also occur with cooperation with regulatory bodies; the exchange of knowledge and experience can only have a positive impact on product safety. As a person who has been supporting cooperation in the area of regulatory affairs for many years, I would like to show, based on examples, how many benefits it can bring.
- 01Cooperation with suppliers and customers during the introduction of a product on the market and further in the life cycle
- 02Cooperation with regulatory bodies during the registration process and new guidelines/requirements coming into force
- 03Challenges and benefits of the above presented based on examples
- 04Despite many challenges, global collaboration can have only benefits
In our presentation, we will talk about how to build a digital bank and digital banking environment in Turkey. What we had done while creating our brand, what we are doing and what are our next steps.
Hottest topics
LOOK AT THE TOPICS THAT WERE DISCUSSED
- 01EU pharma legislation reform: What it means for regulatory affairs
- 02Challenges in collaborative efforts between big pharma and regulatory agencies
- 03Exploring the journey of eCTD 4.0
- 04Digital transformation and AI synergy
- 05Leveraging RWE to strengthen collaborations with regulatory authorities
- 06Achieving the right balance between personalised care and regulatory compliance
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