Speakers
Sample of Keynote Speakers and their Case Studies
CASE STUDY
Creating Value for Patients: Integrating Regulatory Affairs and Pharmacovigilance
In today’s pharmaceutical environment, consolidating RA and PV can deliver significant advantages – a common strategic focus on maximising portfolio success for the ultimate benefit of patients. This session is about sharing a journey of transforming two functions into a single organisation.
- 01Timely evolution in ways of working
- 02Blueprint for change: Implementing a globally aligned organisation while remaining focused on business priorities
- 03A year later, how is it going?
- 04Practical takeaways, lessons learned and what we would do again
CASE STUDY
When Innovation Meets Faster Than Regulations - Collaborating to Advance Transformational Medical Products
Innovation throughout the entire drug development lifecycle. Rapid advances in pharmaceutical science—spanning gene and cell therapies, digital health technologies, artificial intelligence–driven drug development, and novel clinical trial designs—are increasingly outpacing the pace of regulatory evolution. This innovation–regulation gap presents both challenges and opportunities for industry and regulatory authorities, particularly the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Proactive, structured partnerships offer a path to ensure that regulatory frameworks remain fit for purpose while enabling timely patient access to safe, effective, and high‑quality therapies.
Collaborative mechanisms such as parallel scientific advice, innovation offices, regulatory sandboxes, qualification programs, and real‑world evidence pilots allow regulators and developers to co‑create scientific understanding, reduce uncertainty, and accelerate development pathways. This abstract explores how coordinated engagement between pharmaceutical companies and regulatory bodies can support regulatory agility, promote global harmonisation, and foster responsible innovation in an era where scientific discovery is moving at unprecedented speed.
- 01Innovations within the drug development lifecycle
- 02Rapid and/or disruptive innovation can pressure-test the standard regulatory pathways
- 03Collaborations between industry and regulators can build a shared scientific understanding of new technologies and reduce regulatory uncertainty
CASE STUDY
Navigating Complexity into Predictable Outcomes: Regulatory Excellence in Emerging Markets
Emerging markets present some of the most diverse and fast-evolving regulatory environments in the world, marked by varying requirements, language barriers and limited harmonisation. For global organisations, this complexity can create unpredictability, operational risks and barriers to timely submissions and approvals. Presentation explores a strategic risk-model approach to transforming regulatory complexity into predictable outcomes. Drawing from real-world operational challenges, it highlights how structured data models, aligned terminology, clear governance, and capability setting can reduce variability and strengthen decision-making. Participants will gain a framework that can help enhance regulatory consistency, improve data quality and build future-ready regulatory operations that remain resilient in the face of changing global regulatory environments.
- 01Prioritise markets and activities based on regulatory impact and variability (focus effort where the risk of non-compliance, data inconsistency, or process deviation is highest)
- 02Reduce operational burden by standardising what can be standardised (low-risk markets that can follow simplified/harmonised procedures to reduce the noise)
- 03Allocate expert resources to the areas that require nuance (concentrate efforts where judgment and local expertise
CASE STUDY
Beyond Compliance: How Regulatory Intelligence Drives Business Decisions
Regulatory Affairs is no longer a support function – it is a strategic driver of business performance. In an environment defined by acceleration, digitalisation, and zero tolerance for error, companies that fail to integrate regulatory intelligence into decision-making risk delays, inefficiencies and lost opportunities.
This session explores how global regulatory trends are reshaping the role of Regulatory Affairs – from execution to strategy – and how organisations can translate intelligence into faster approvals, better portfolio choices and sustainable competitive advantage.
CASE STUDY
Data Quality by Design: How IDMP Ontology Accelerates Global Regulatory Harmonisation
As regulatory ecosystems shift toward data‑driven, modular, and globally aligned operating models, the quality and interoperability of regulatory data are becoming decisive strategic differentiators. This presentation explores how strong data foundations—governance, metadata discipline, and cross‑system interoperability—enable organisations to turn data into strategy rather than into an operational burden. Using ISO IDMP and the emerging IDMP Ontology as the backbone, the session will illustrate how semantic standards can reduce regional divergence, strengthen regulatory trust, and allow first movers to thrive in a landscape increasingly shaped by digital standards, AI‑enabled submissions, and global harmonisation efforts.
- 01 Why data quality matters more than ever in the emerging regulatory reality
- 02 IDMP as the backbone of regulatory data
- 03 From standards to semantics: The role of the IDMP Ontology
- 04 Strategic implications for Global regulatory affairs: Why first movers win
CASE STUDY
Creating Value for Patients: Integrating Regulatory Affairs and Pharmacovigilance
In today’s pharmaceutical environment, consolidating RA and PV can deliver significant advantages – a common strategic focus on maximising portfolio success for the ultimate benefit of patients. This session is about sharing a journey of transforming two functions into a single organisation.
- 01Timely evolution in ways of working
- 02Blueprint for change: Implementing a globally aligned organisation while remaining focused on business priorities
- 03A year later, how is it going?
- 04Practical takeaways, lessons learned and what we would do again
CASE STUDY
When Innovation Meets Faster Than Regulations - Collaborating to Advance Transformational Medical Products
Innovation throughout the entire drug development lifecycle. Rapid advances in pharmaceutical science—spanning gene and cell therapies, digital health technologies, artificial intelligence–driven drug development, and novel clinical trial designs—are increasingly outpacing the pace of regulatory evolution. This innovation–regulation gap presents both challenges and opportunities for industry and regulatory authorities, particularly the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Proactive, structured partnerships offer a path to ensure that regulatory frameworks remain fit for purpose while enabling timely patient access to safe, effective, and high‑quality therapies.
Collaborative mechanisms such as parallel scientific advice, innovation offices, regulatory sandboxes, qualification programs, and real‑world evidence pilots allow regulators and developers to co‑create scientific understanding, reduce uncertainty, and accelerate development pathways. This abstract explores how coordinated engagement between pharmaceutical companies and regulatory bodies can support regulatory agility, promote global harmonisation, and foster responsible innovation in an era where scientific discovery is moving at unprecedented speed.
- 01Innovations within the drug development lifecycle
- 02Rapid and/or disruptive innovation can pressure-test the standard regulatory pathways
- 03Collaborations between industry and regulators can build a shared scientific understanding of new technologies and reduce regulatory uncertainty
CASE STUDY
Navigating Complexity into Predictable Outcomes: Regulatory Excellence in Emerging Markets
Emerging markets present some of the most diverse and fast-evolving regulatory environments in the world, marked by varying requirements, language barriers and limited harmonisation. For global organisations, this complexity can create unpredictability, operational risks and barriers to timely submissions and approvals. Presentation explores a strategic risk-model approach to transforming regulatory complexity into predictable outcomes. Drawing from real-world operational challenges, it highlights how structured data models, aligned terminology, clear governance, and capability setting can reduce variability and strengthen decision-making. Participants will gain a framework that can help enhance regulatory consistency, improve data quality and build future-ready regulatory operations that remain resilient in the face of changing global regulatory environments.
- 01Prioritise markets and activities based on regulatory impact and variability (focus effort where the risk of non-compliance, data inconsistency, or process deviation is highest)
- 02Reduce operational burden by standardising what can be standardised (low-risk markets that can follow simplified/harmonised procedures to reduce the noise)
- 03Allocate expert resources to the areas that require nuance (concentrate efforts where judgment and local expertise
CASE STUDY
Beyond Compliance: How Regulatory Intelligence Drives Business Decisions
Regulatory Affairs is no longer a support function – it is a strategic driver of business performance. In an environment defined by acceleration, digitalisation, and zero tolerance for error, companies that fail to integrate regulatory intelligence into decision-making risk delays, inefficiencies and lost opportunities.
This session explores how global regulatory trends are reshaping the role of Regulatory Affairs – from execution to strategy – and how organisations can translate intelligence into faster approvals, better portfolio choices and sustainable competitive advantage.
CASE STUDY
Data Quality by Design: How IDMP Ontology Accelerates Global Regulatory Harmonisation
As regulatory ecosystems shift toward data‑driven, modular, and globally aligned operating models, the quality and interoperability of regulatory data are becoming decisive strategic differentiators. This presentation explores how strong data foundations—governance, metadata discipline, and cross‑system interoperability—enable organisations to turn data into strategy rather than into an operational burden. Using ISO IDMP and the emerging IDMP Ontology as the backbone, the session will illustrate how semantic standards can reduce regional divergence, strengthen regulatory trust, and allow first movers to thrive in a landscape increasingly shaped by digital standards, AI‑enabled submissions, and global harmonisation efforts.
- 01 Why data quality matters more than ever in the emerging regulatory reality
- 02 IDMP as the backbone of regulatory data
- 03 From standards to semantics: The role of the IDMP Ontology
- 04 Strategic implications for Global regulatory affairs: Why first movers win
CASE STUDY
Creating Value for Patients: Integrating Regulatory Affairs and Pharmacovigilance
In today’s pharmaceutical environment, consolidating RA and PV can deliver significant advantages – a common strategic focus on maximising portfolio success for the ultimate benefit of patients. This session is about sharing a journey of transforming two functions into a single organisation.
- 01Timely evolution in ways of working
- 02Blueprint for change: Implementing a globally aligned organisation while remaining focused on business priorities
- 03A year later, how is it going?
- 04Practical takeaways, lessons learned and what we would do again
CASE STUDY
When Innovation Meets Faster Than Regulations - Collaborating to Advance Transformational Medical Products
Innovation throughout the entire drug development lifecycle. Rapid advances in pharmaceutical science—spanning gene and cell therapies, digital health technologies, artificial intelligence–driven drug development, and novel clinical trial designs—are increasingly outpacing the pace of regulatory evolution. This innovation–regulation gap presents both challenges and opportunities for industry and regulatory authorities, particularly the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Proactive, structured partnerships offer a path to ensure that regulatory frameworks remain fit for purpose while enabling timely patient access to safe, effective, and high‑quality therapies.
Collaborative mechanisms such as parallel scientific advice, innovation offices, regulatory sandboxes, qualification programs, and real‑world evidence pilots allow regulators and developers to co‑create scientific understanding, reduce uncertainty, and accelerate development pathways. This abstract explores how coordinated engagement between pharmaceutical companies and regulatory bodies can support regulatory agility, promote global harmonisation, and foster responsible innovation in an era where scientific discovery is moving at unprecedented speed.
- 01Innovations within the drug development lifecycle
- 02Rapid and/or disruptive innovation can pressure-test the standard regulatory pathways
- 03Collaborations between industry and regulators can build a shared scientific understanding of new technologies and reduce regulatory uncertainty
CASE STUDY
Navigating Complexity into Predictable Outcomes: Regulatory Excellence in Emerging Markets
Emerging markets present some of the most diverse and fast-evolving regulatory environments in the world, marked by varying requirements, language barriers and limited harmonisation. For global organisations, this complexity can create unpredictability, operational risks and barriers to timely submissions and approvals. Presentation explores a strategic risk-model approach to transforming regulatory complexity into predictable outcomes. Drawing from real-world operational challenges, it highlights how structured data models, aligned terminology, clear governance, and capability setting can reduce variability and strengthen decision-making. Participants will gain a framework that can help enhance regulatory consistency, improve data quality and build future-ready regulatory operations that remain resilient in the face of changing global regulatory environments.
- 01Prioritise markets and activities based on regulatory impact and variability (focus effort where the risk of non-compliance, data inconsistency, or process deviation is highest)
- 02Reduce operational burden by standardising what can be standardised (low-risk markets that can follow simplified/harmonised procedures to reduce the noise)
- 03Allocate expert resources to the areas that require nuance (concentrate efforts where judgment and local expertise
CASE STUDY
Beyond Compliance: How Regulatory Intelligence Drives Business Decisions
Regulatory Affairs is no longer a support function – it is a strategic driver of business performance. In an environment defined by acceleration, digitalisation, and zero tolerance for error, companies that fail to integrate regulatory intelligence into decision-making risk delays, inefficiencies and lost opportunities.
This session explores how global regulatory trends are reshaping the role of Regulatory Affairs – from execution to strategy – and how organisations can translate intelligence into faster approvals, better portfolio choices and sustainable competitive advantage.
CASE STUDY
Data Quality by Design: How IDMP Ontology Accelerates Global Regulatory Harmonisation
As regulatory ecosystems shift toward data‑driven, modular, and globally aligned operating models, the quality and interoperability of regulatory data are becoming decisive strategic differentiators. This presentation explores how strong data foundations—governance, metadata discipline, and cross‑system interoperability—enable organisations to turn data into strategy rather than into an operational burden. Using ISO IDMP and the emerging IDMP Ontology as the backbone, the session will illustrate how semantic standards can reduce regional divergence, strengthen regulatory trust, and allow first movers to thrive in a landscape increasingly shaped by digital standards, AI‑enabled submissions, and global harmonisation efforts.
- 01 Why data quality matters more than ever in the emerging regulatory reality
- 02 IDMP as the backbone of regulatory data
- 03 From standards to semantics: The role of the IDMP Ontology
- 04 Strategic implications for Global regulatory affairs: Why first movers win