SPEAKERS

SAMPLE OF KEYNOTE SPEAKERS AND THEIR CASE STUDIES

Katerina SAKKOULA

Head of Affiliate Global Interface (AGI)

CASE STUDY / DAY 1

Let's Transform Safety with End-to-End PV Solutions

A journey of our transformation as an organization to imagine the future of Affiliate Patient Safety around the world.

CASE STUDY / DAY 1

Advances in Structured Benefit-Risk Assessment

This presentation aims to display the recent advances in Benefit-Risk field from new regulatory guidance, changes in BR methods to illustration of growing role of patient experience data into BR evaluation.

  • Recent changes in Benefit-Risk regulatory landscape
  • Improved use of Patient Experience Data for Benefit-Risk evaluation
  • Trends and perspectives for the future in Benefit-Risk methods

Stephanie TCHERNY

Global Head of Benefit-Risk Evaluation

SUMMIT WILL HOST SPEAKERS FROM THE WORLD’S LEADING COMPANIES

Katerina SAKKOULA

Head of Affiliate Global Interface (AGI)

CASE STUDY DAY 1

Let's Transform Safety with End-to-End PV Solutions

A journey of our transformation as an organization to imagine the future of Affiliate Patient Safety around the world.

Giovanni FURLAN

Safety Risk Lead, Director

CASE STUDY DAY 2

The Role of Pharmacogenomics in Drug Safety

Patients vary in their response to a drug and genetic factors are estimated to account for 15% -20% of these differences, but for some drugs they can account for up to 95% of inter-individual variability. Frequently, multiple genes contribute to a trait and one gene can have multiple alternative forms with the relevant protein having an activity that can range from high to low. The presentation will provide examples on how both genetic and non-genetic factors influence drug dosing and therefore need to be considered in order reduce the risk of experiencing adverse reactions.

• Pharmacogenomics is the study of the genes, their polymorphism, structure, function, transcription and translation, how they interact with each other and with the environment
• It has been suggested that one third of serious adverse reactions have a genetic variant as a contributory factor
• The metabolic pathways of a drug and its pharmacodynamics are the basis for understanding why some genetic variants require to adapt the drug dose so to minimize the risk of experiencing adverse reactions

Stephanie TCHERNY

Global Head of Benefit-Risk Evaluation

CASE STUDY DAY 2

Advances in Structured Benefit-Risk Assessment

This presentation aims to display the recent advances in Benefit-Risk field from new regulatory guidance, changes in BR methods to illustration of growing role of patient experience data into BR evaluation.

• Recent changes in Benefit-Risk regulatory landscape
• Improved use of Patient Experience Data for Benefit-Risk evaluation
• Trends and perspectives for the future in Benefit-Risk methods

Yvonne NANCIU

Country Head Pharmacovigilance

CASE STUDY DAY 1

The Importance of Embarking the Patients on the Pharmacovigilance Ship

Pharmaceutical companies have been partnering with patients and patient organisations for quite a few years now, especially in engaging them regarding various aspects of clinical trials. Some topics that needs further discussions / development are for example direct safety patient reporting (tools, capacities, education) and involvement of patients in the creation of materials dedicated to them, outside clinical trials.

• Current status patient involvement clinical trials
• Direct safety reporting – status, utilisation, benefits, comparison HCP reporting, future use
• Engaging patients in creating user-friendly, innovative patient-derected-materials
• Future considerations

Michael VON FORSTNER

Head of Pharmacovigilance, Biosimilars

CASE STUDY DAY 1

Predictive Pharmacovigilance

Pharmacovigilance has moved from reactively reporting safety information to planning risk management activities prior to their occurrence. The logical next step would be to use relevant information beyond the safety data to combine various types of real-world evidence in order to predict risks for individual patients or patient groups. In this presentation we will discuss attempts to reach this goal.

• Machine Learning/Artificial Intelligence for bias-free identification of risk factors for ADRs
• Types of data available for predictive approaches
• Learning from other medical and non-medical approaches
• Trends

Yvonne NANCIU

Country Head Pharmacovigilance

CASE STUDY / DAY 2

The Importance of Embarking the Patients on the Pharmacovigilance Ship

Pharmaceutical companies have been partnering with patients and patient organisations for quite a few years now, especially in engaging them regarding various aspects of clinical trials. Some topics that needs further discussions / development are for example direct safety patient reporting (tools, capacities, education) and involvement of patients in the creation of materials dedicated to them, outside clinical trials.

  • Current status patient involvement clinical trials
  • Direct safety reporting – status, utilisation, benefits, comparison HCP reporting, future use
  • Engaging patients in creating user-friendly, innovative patient-derected-materials
  • Future considerations
CASE STUDY / DAY 2

Predictive Pharmacovigilance

Pharmacovigilance has moved from reactively reporting safety information to planning risk management activities prior to their occurrence. The logical next step would be to use relevant information beyond the safety data to combine various types of real-world evidence in order to predict risks for individual patients or patient groups. In this presentation we will discuss attempts to reach this goal.

  • Machine Learning/Artificial Intelligence for bias-free identification of risk factors for ADRs
  • Types of data available for predictive approaches
  • Learning from other medical and non-medical approaches
  • Trends

Michael VON FORSTNER

Head of Pharmacovigilance, Biosimilars

Giovanni FURLAN

Safety Risk Lead, Director

CASE STUDY / DAY 2

The Role of Pharmacogenomics in Drug Safety

Patients vary in their response to a drug and genetic factors are estimated to account for 15% -20% of these differences, but for some drugs they can account for up to 95% of inter-individual variability. Frequently, multiple genes contribute to a trait and one gene can have multiple alternative forms with the relevant protein having an activity that can range from high to low.  The presentation will provide examples on how both genetic and non-genetic factors influence drug dosing and therefore need to be considered in order reduce the risk of experiencing adverse reactions.

  • Pharmacogenomics is the study of the genes, their polymorphism, structure, function, transcription and translation, how they interact with each other and with the environment
  • It has been suggested that one third of serious adverse reactions have a genetic variant as a contributory factor
  • The metabolic pathways of a drug and its pharmacodynamics are the basis for understanding why some genetic variants require to adapt the drug dose so to minimize the risk of experiencing adverse reactions

I really enjoyed learning from highly relevant presentations and lively discussions, and I will be definitely very happy to join the summit next year.

– Associate Director Global Regulatory Affairs, Translational Medicine & Devices, Merck

Event programme

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