13th Annual Risk
Management and Pharmacovigilance
Summit
The official date for the summit will be announced soon
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Past Speakers
SEE THE PREVIOUS SPEAKERS & CASE STUDIES
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Yuri van Geertruij
Executive Director, Sub-Regional Lead for Mid-Sized Markets
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
In this session, I’ll explore the critical role of being the bridge between product and technology, where true product development excellence happens. Drawing on my experience in transformation, including agile transformation and large-scale delivery, I’ll share how connecting vision with execution, and people with purpose leads to better collaboration, stronger outcomes, and more impactful products — the cornerstone of product and agile excellence.
Show More
Alex Bica
Global Head Early Development and Translational Safety
CASE STUDY
From Signals to Strategy: How AI-Enabled Translational Safety Is Redefining Risk Management and Regulatory Confidence
As pharmacovigilance evolves from reactive signal management to proactive risk intelligence, the boundary between early development, translational safety, and regulatory risk management is rapidly disappearing. Yet many organisations still rely on fragmented safety inputs, late-stage mitigation, and narrative-driven justifications that struggle to scale with data complexity and emerging therapeutic modalities. This presentation explores how AI-enabled translational safety can
strengthen risk management across the product lifecycle and materially improve regulatory confidence. By integrating preclinical insights, early clinical signals, and real-world context into unified analytical frameworks,
AI methods can support risk prioritisation, uncertainty quantification, and predictive safety assessment far earlier than traditional pharmacovigilance approaches.
The session will illustrate how properly executed translational safety— augmented by machine learning, pattern recognition, and probabilistic modelling—can:
Show More
- 01Anticipate clinically relevant risks before they emerge as post-marketing signals
- 02Inform risk management plans with evidence-based, forward-looking rationale
- 03Improve consistency, transparency, and credibility in regulatory interactions
- 04Enable regulators and sponsors to focus on what truly matters for patient safety
Three years ago, we set out to rebuild our organisation around the customer journey, rather than brands and channels. We introduced agile, cross-functional teams and created new roles, which are accountable for optimising key touchpoints across personas and channels. Through regular huddles with the Field Force, Medical, and Content Strategy teams, we turned insights from the field into rapid experiments and visible improvements. In this session, I will share how we designed these roles, how the huddles work in practice, and what we learned, both culturally and structurally, along the way.
Friederike Hoffgen
Area Safety Head Germany & CE
CASE STUDY
Trust in Action: Building Integrity and Openness in Modern Pharmacovigilance
The critical roles of ethics, transparency, and accountability in ensuring drug safety and fostering public trust will be explored, with a particular focus on overcoming challenges in the field. By examining key obstacles and highlighting innovative practices, the presentation aims to inspire stakeholders to prioritise integrity and collaboration in their pharmacovigilance efforts.
- 01Relevance of ethics, transparency, and accountability in the field;
- 02Importance of ethical considerations in drug safety monitoring
- 03Definition and significance of transparency in pharmacovigilance;
- 04Mechanisms to improve transparency (e.g., open data initiatives, public reporting);
- 05Identification of common challenges in implementing ethical practices
- 06Transparency, and accountability;
- 07Future direction- innovation in technology, role of collaboration between stakeholders, importance of ongoing education and training
In an evolving landscape where customer expectations continually rise, understanding and proactively addressing customer needs is no longer optional—it’s essential. This session explores how empathy-driven customer experience (CX), combined with strategic automation and cutting-edge AI, can radically enhance efficiency, agent performance, and customer loyalty. Leveraging real-world insights and innovative frameworks, discover practical ways to future-proof your contact centre operations.
Show More
Ghazi El Masri
Quality Auditor, Senior Manager
CASE STUDY
Managing the Increased Pharmacovigilance Audit Burden After the 2025 Regulation Update: Strategic Approaches to Streamline PV Operations
Examine the effects of the updated Regulation (EC) No 726/2004 –2025/1466 on pharmacovigilance workload and audit frequency; present GSKs cluster Third-Party audit strategy and practical measures to optimise audit processes, improve operational efficiency, and maintain regulatory compliance.
- 01Introduce the updated Regulation (EC) No 726/2004 – 2025/1466 on PV Audit
- 02Present GSK’s cluster Third-Party audit strategy
- 03Practical measures to optimise audit processes, improve operational efficiency, and maintain regulatory compliance
At Accor, our journey in embedding Strength-Based Leadership and building an ecosystem of coaches is a strategic priority and a cornerstone of our people development philosophy.
In our pursuit of a coaching culture, we’ve implemented a range of initiatives that bring together the best different developmental resources. These initiatives are not standalone programmes; they are part of a deliberate, connected effort to empower our leaders and teams. By focusing on individual and collective strengths, and grounded in core coaching principles, we are shaping a workplace where continuous learning, empathy, and performance go hand in hand. This culture fosters not only personal growth but also drives team resilience, engagement, and business impact.
Rather than just talking about the theory, we want you to hear directly from our leaders. They will share how adopting a coaching mindset has transformed their leadership and the tangible difference it has made for their teams and the organisation as a whole.
Show More
Anna Kończak
EU QPPV
CASE STUDY
Leading Pharmacovigilance Through Inspection (Audit): QPPV Leadership Lessons from Remote Teams
This presentation explores the leadership dimension of preparing for and undergoing audits and inspections in remote pharmacovigilance teams, from the perspective of a QPPV. Beyond processes and documentation, inspections test leadership: decision‑making under pressure, prioritisation in resource‑constrained environments, and the ability to maintain team stability and trust during periods of heightened regulatory scrutiny.
The session reflects on how QPPVs can effectively lead distributed teams before and during inspections, balancing compliance requirements with operational reality. The presentation discusses how to build resilient operational streams, establish clear accountability, and organise work in a way that supports both inspection readiness and day‑to‑day pharmacovigilance activities. Particular attention is given to leadership challenges specific to remote models, including managing documentation across locations, addressing technical and IT security constraints, and navigating data protection considerations.
Drawing on real‑life inspection experience, the session highlights what inspectors focus on versus what organisations often over‑prepare, and how leadership behaviours directly influence inspection outcomes. The talk concludes with practical lessons learned for QPPVs and PV leaders
seeking to strengthen oversight, team engagement, and organisational confidence in remote pharmacovigilance settings.
Show More
This session explores how digital transformation can elevate back office operations beyond pure efficiency, transforming them into empathy‑driven systems that strengthen trust and customer relationships. Maurice will share global insights on integrating technology with human expertise to build resilient, customer‑centric banking models for the future.
- 01What defines a truly responsible supplier relationship in today’s volatile market?
- 02Why board-level procurement engagement is now a competitive differentiator
- 03How to build C-suite alignment for sustainability and ethics in procurement
- 04Future-forward procurement: Vision 2035 and beyond
Yuri van Geertruij
Executive Director, Sub-Regional Lead for Mid-Sized Markets
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
In this session, I’ll explore the critical role of being the bridge between product and technology, where true product development excellence happens. Drawing on my experience in transformation, including agile transformation and large-scale delivery, I’ll share how connecting vision with execution, and people with purpose leads to better collaboration, stronger outcomes, and more impactful products — the cornerstone of product and agile excellence.
Show More
Alex Bica
Global Head Early Development and Translational Safety
CASE STUDY
From Signals to Strategy: How AI-Enabled Translational Safety Is Redefining Risk Management and Regulatory Confidence
As pharmacovigilance evolves from reactive signal management to proactive risk intelligence, the boundary between early development, translational safety, and regulatory risk management is rapidly disappearing. Yet many organisations still rely on fragmented safety inputs, late-stage mitigation, and narrative-driven justifications that struggle to scale with data complexity and emerging therapeutic modalities. This presentation explores how AI-enabled translational safety can
strengthen risk management across the product lifecycle and materially improve regulatory confidence. By integrating preclinical insights, early clinical signals, and real-world context into unified analytical frameworks,
AI methods can support risk prioritisation, uncertainty quantification, and predictive safety assessment far earlier than traditional pharmacovigilance approaches.
The session will illustrate how properly executed translational safety— augmented by machine learning, pattern recognition, and probabilistic modelling—can:
Show More
- 01Anticipate clinically relevant risks before they emerge as post-marketing signals
- 02Inform risk management plans with evidence-based, forward-looking rationale
- 03Improve consistency, transparency, and credibility in regulatory interactions
- 04Enable regulators and sponsors to focus on what truly matters for patient safety
Three years ago, we set out to rebuild our organisation around the customer journey, rather than brands and channels. We introduced agile, cross-functional teams and created new roles, which are accountable for optimising key touchpoints across personas and channels. Through regular huddles with the Field Force, Medical, and Content Strategy teams, we turned insights from the field into rapid experiments and visible improvements. In this session, I will share how we designed these roles, how the huddles work in practice, and what we learned, both culturally and structurally, along the way.
Friederike Hoffgen
Area Safety Head Germany & CE
CASE STUDY
Trust in Action: Building Integrity and Openness in Modern Pharmacovigilance
The critical roles of ethics, transparency, and accountability in ensuring drug safety and fostering public trust will be explored, with a particular focus on overcoming challenges in the field. By examining key obstacles and highlighting innovative practices, the presentation aims to inspire stakeholders to prioritise integrity and collaboration in their pharmacovigilance efforts.
- 01Relevance of ethics, transparency, and accountability in the field;
- 02Importance of ethical considerations in drug safety monitoring
- 03Definition and significance of transparency in pharmacovigilance;
- 04Mechanisms to improve transparency (e.g., open data initiatives, public reporting);
- 05Identification of common challenges in implementing ethical practices
- 06Transparency, and accountability;
- 07Future direction- innovation in technology, role of collaboration between stakeholders, importance of ongoing education and training
In an evolving landscape where customer expectations continually rise, understanding and proactively addressing customer needs is no longer optional—it’s essential. This session explores how empathy-driven customer experience (CX), combined with strategic automation and cutting-edge AI, can radically enhance efficiency, agent performance, and customer loyalty. Leveraging real-world insights and innovative frameworks, discover practical ways to future-proof your contact centre operations.
Show More
Ghazi El Masri
Quality Auditor, Senior Manager
CASE STUDY
Managing the Increased Pharmacovigilance Audit Burden After the 2025 Regulation Update: Strategic Approaches to Streamline PV Operations
Examine the effects of the updated Regulation (EC) No 726/2004 –2025/1466 on pharmacovigilance workload and audit frequency; present GSKs cluster Third-Party audit strategy and practical measures to optimise audit processes, improve operational efficiency, and maintain regulatory compliance.
- 01Introduce the updated Regulation (EC) No 726/2004 – 2025/1466 on PV Audit
- 02Present GSK’s cluster Third-Party audit strategy
- 03Practical measures to optimise audit processes, improve operational efficiency, and maintain regulatory compliance
At Accor, our journey in embedding Strength-Based Leadership and building an ecosystem of coaches is a strategic priority and a cornerstone of our people development philosophy.
In our pursuit of a coaching culture, we’ve implemented a range of initiatives that bring together the best different developmental resources. These initiatives are not standalone programmes; they are part of a deliberate, connected effort to empower our leaders and teams. By focusing on individual and collective strengths, and grounded in core coaching principles, we are shaping a workplace where continuous learning, empathy, and performance go hand in hand. This culture fosters not only personal growth but also drives team resilience, engagement, and business impact.
Rather than just talking about the theory, we want you to hear directly from our leaders. They will share how adopting a coaching mindset has transformed their leadership and the tangible difference it has made for their teams and the organisation as a whole.
Show More
Anna Kończak
EU QPPV
CASE STUDY
Leading Pharmacovigilance Through Inspection (Audit): QPPV Leadership Lessons from Remote Teams
This presentation explores the leadership dimension of preparing for and undergoing audits and inspections in remote pharmacovigilance teams, from the perspective of a QPPV. Beyond processes and documentation, inspections test leadership: decision‑making under pressure, prioritisation in resource‑constrained environments, and the ability to maintain team stability and trust during periods of heightened regulatory scrutiny.
The session reflects on how QPPVs can effectively lead distributed teams before and during inspections, balancing compliance requirements with operational reality. The presentation discusses how to build resilient operational streams, establish clear accountability, and organise work in a way that supports both inspection readiness and day‑to‑day pharmacovigilance activities. Particular attention is given to leadership challenges specific to remote models, including managing documentation across locations, addressing technical and IT security constraints, and navigating data protection considerations.
Drawing on real‑life inspection experience, the session highlights what inspectors focus on versus what organisations often over‑prepare, and how leadership behaviours directly influence inspection outcomes. The talk concludes with practical lessons learned for QPPVs and PV leaders
seeking to strengthen oversight, team engagement, and organisational confidence in remote pharmacovigilance settings.
Show More
This session explores how digital transformation can elevate back office operations beyond pure efficiency, transforming them into empathy‑driven systems that strengthen trust and customer relationships. Maurice will share global insights on integrating technology with human expertise to build resilient, customer‑centric banking models for the future.
- 01What defines a truly responsible supplier relationship in today’s volatile market?
- 02Why board-level procurement engagement is now a competitive differentiator
- 03How to build C-suite alignment for sustainability and ethics in procurement
- 04Future-forward procurement: Vision 2035 and beyond
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
- 01Inspection trends in 2026: What regulators now focus on first
- 02From document to living framework: Operationalising RMPs
- 03New expectations for signal detection timelines and documentation
- 04Metrics that matter: Beyond ICSR submission timelines
- 05Data integrity findings in PV: Lessons learned the hard way
- 06Cross-functional ownership: Who controls RWE in PV?
- 07Transparency in safety decision-making
- 08From operational execution to strategic safety leadership
Testimonials
What our users say about our conferences
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Very well organised summit packed with resourceful presentations. It was a fantastic conference!Union National Bank Chief Human Resources Officer
Great event, very good topics and discussions with diverse participantsLandmark Group Head – Rewards & Organisational Effectiveness,
Good overall, I gain a lot of useful information. Lots of insights to learn from and a great speaker line-up.Abu Dhabi Airports Total Rewards Head, Senior Manager Organisation Development
Great conference. I really liked meeting the other participants and the opportunity to openly share insights.AdidasDirector Compensation Programmes
Very relevant topics from everyday practicalities to more visionary. Experienced & knowledgeable speakers. I really liked the quality of topics and their usefulness.PfizerSenior Director Safety Risk Lead
Very good conference with a friendly atmosphere and a panel of very good experts. Discussions were very lively and open.SanofiHead of QPPV Office
Good event where pharma companies can exchange experience. I got a very good overview about the hot topics in PV and current needs and developments.Vifor PharmaHead Clinical Drug Safety
The right number of participants allowing for good interaction between peers. Interesting topics with studies.TakedaAssociate Director, PV Compliance
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