In our 1-hour webinar on the 12 of July 2017 (4:30pm CET, 3:30pm BST, 10:30am EST) we will have a presentation by Conny Berlin who is the industry project leader of the public-private IMI PREFER project and Rachael DiSantostefano, a task co-leader on the IMI PREFER project.
Abstract
The main objective of the IMI PREFER project is to strengthen patient-centric decision making throughout the life cycle of medicinal products by developing evidence-based recommendations to guide industry, Regulatory Authorities, HTA bodies, reimbursement agencies, academia, and health care professionals on how and when patient-preference studies should be performed and the results used to support and inform decision making.
While over the last years all stakeholders gained experience individually how to engage patients for decision making this project aims to bring all stakeholders together taking a structured approach to determine their needs, expectations, and concerns regarding the use of patient-preference information and methodologies for patient-preference elicitation.
Methodologies for patient value elicitation are available and have been used frequently in market research, in health economics and outcomes research to substantiate real-life evidence. Further structured research has been done in projects like IMI PROTECT but there is no systematic use of these methodologies in the regulatory licensing processes yet.
The presentation will address
Objective of PREFER
Changing environment
Patient preference study example
PREFER participants
PREFER project approach & status
About the Presenters
Conny Berlin, Global Head Quantitative Safety & Epidemiology,
Novartis International AG
Conny Berlin leads the Quantitative Safety & Epidemiology group at Novartis International AG. She holds a degree in mathematics from the University of Rostock, Germany and has more than 25 years of experience within the pharmaceutical industry.
Conny Berlin has a profound knowledge of quantitative methodology as applied to clinical and observational data and to spontaneous reports to respond to safety and benefit-risk questions during drug development and post-approval.
Conny Berlin is a member of the company’s internal Medical Safety Review Board and of the Real World Evidence Leadership Team.
She is well experienced in managing projects, leading and coordinating interdisciplinary teams. Conny Berlin is the industry project leader of the public-private IMI PREFER project.
Relevant references
Esther W. de Bekker-Grob, Conny Berlin et al. Giving Patients’ Preferences a Voice in Medical Treatment Life Cycle: The PREFER Public–Private Project. Patient: Editorial
Participant of the CIOMS working group X on "Evidence Synthesis and Meta-Analysis for Drug Safety"; report published in 2016
Berlin C, Blanch C et al. Are all quantitative postmarketing signal detection methods equal? Performance characteristics of logistic regression and Multi-item Gamma Poisson Shrinker. Pharmacoepidemiology and Drug Safety. 2011: 622-630
Rachael DiSantostefano, PhD, MS is a Director, Benefit-Risk in Epidemiology at Janssen R&D
Rachael L. DiSantostefano has nearly 25 years of pharmaceutical research experience across the quantitative disciplines of epidemiology, biostatistics, and health outcomes. She is currently responsible for guiding clinical teams in structured benefit-risk assessment, including the use of both qualitative and quantitative methods. She received her PhD in Health Policy and her Master’s degree in Biostatistics at the University of North Carolina Gillings School of Global Public Health. Prior to joining Janssen in 2015, she was an epidemiologist at another pharmaceutical company for 10 years, where she evaluated medication safety and contributed to benefit-risk assessment in regulatory submissions and at FDA Advisory Committee meetings. She is currently active as a task co-leader on the IMI PREFER project and an active member of the Benefit-Risk Assessment Communication and Evaluation Special Interest Group (BRACE-SIG) within the International Society for Pharmacoepidemiology.
In our 1-hour webinar on the 12 of July 2017 (4:30pm CET, 3:30pm BST, 10:30am EST) we will have a presentation by Conny Berlin who is the industry project leader of the public-private IMI PREFER project and Rachael DiSantostefano, a task co-leader on the IMI PREFER project.
Abstract
The main objective of the IMI PREFER project is to strengthen patient-centric decision making throughout the life cycle of medicinal products by developing evidence-based recommendations to guide industry, Regulatory Authorities, HTA bodies, reimbursement agencies, academia, and health care professionals on how and when patient-preference studies should be performed and the results used to support and inform decision making.
While over the last years all stakeholders gained experience individually how to engage patients for decision making this project aims to bring all stakeholders together taking a structured approach to determine their needs, expectations, and concerns regarding the use of patient-preference information and methodologies for patient-preference elicitation.
Methodologies for patient value elicitation are available and have been used frequently in market research, in health economics and outcomes research to substantiate real-life evidence. Further structured research has been done in projects like IMI PROTECT but there is no systematic use of these methodologies in the regulatory licensing processes yet.
The presentation will address
Objective of PREFER
Changing environment
Patient preference study example
PREFER participants
PREFER project approach & status
About the Presenters
Conny Berlin, Global Head Quantitative Safety & Epidemiology,
Novartis International AG
Conny Berlin leads the Quantitative Safety & Epidemiology group at Novartis International AG. She holds a degree in mathematics from the University of Rostock, Germany and has more than 25 years of experience within the pharmaceutical industry.
Conny Berlin has a profound knowledge of quantitative methodology as applied to clinical and observational data and to spontaneous reports to respond to safety and benefit-risk questions during drug development and post-approval.
Conny Berlin is a member of the company’s internal Medical Safety Review Board and of the Real World Evidence Leadership Team.
She is well experienced in managing projects, leading and coordinating interdisciplinary teams. Conny Berlin is the industry project leader of the public-private IMI PREFER project.
Relevant references
Esther W. de Bekker-Grob, Conny Berlin et al. Giving Patients’ Preferences a Voice in Medical Treatment Life Cycle: The PREFER Public–Private Project. Patient: Editorial
Participant of the CIOMS working group X on "Evidence Synthesis and Meta-Analysis for Drug Safety"; report published in 2016
Berlin C, Blanch C et al. Are all quantitative postmarketing signal detection methods equal? Performance characteristics of logistic regression and Multi-item Gamma Poisson Shrinker. Pharmacoepidemiology and Drug Safety. 2011: 622-630
Rachael DiSantostefano, PhD, MS is a Director, Benefit-Risk in Epidemiology at Janssen R&D
Rachael L. DiSantostefano has nearly 25 years of pharmaceutical research experience across the quantitative disciplines of epidemiology, biostatistics, and health outcomes. She is currently responsible for guiding clinical teams in structured benefit-risk assessment, including the use of both qualitative and quantitative methods. She received her PhD in Health Policy and her Master’s degree in Biostatistics at the University of North Carolina Gillings School of Global Public Health. Prior to joining Janssen in 2015, she was an epidemiologist at another pharmaceutical company for 10 years, where she evaluated medication safety and contributed to benefit-risk assessment in regulatory submissions and at FDA Advisory Committee meetings. She is currently active as a task co-leader on the IMI PREFER project and an active member of the Benefit-Risk Assessment Communication and Evaluation Special Interest Group (BRACE-SIG) within the International Society for Pharmacoepidemiology.
In our 1-hour webinar on the 12 of July 2017 (4:30pm CET, 3:30pm BST, 10:30am EST) we will have a presentation by Conny Berlin who is the industry project leader of the public-private IMI PREFER project and Rachael DiSantostefano, a task co-leader on the IMI PREFER project.
Abstract
The main objective of the IMI PREFER project is to strengthen patient-centric decision making throughout the life cycle of medicinal products by developing evidence-based recommendations to guide industry, Regulatory Authorities, HTA bodies, reimbursement agencies, academia, and health care professionals on how and when patient-preference studies should be performed and the results used to support and inform decision making.
While over the last years all stakeholders gained experience individually how to engage patients for decision making this project aims to bring all stakeholders together taking a structured approach to determine their needs, expectations, and concerns regarding the use of patient-preference information and methodologies for patient-preference elicitation.
Methodologies for patient value elicitation are available and have been used frequently in market research, in health economics and outcomes research to substantiate real-life evidence. Further structured research has been done in projects like IMI PROTECT but there is no systematic use of these methodologies in the regulatory licensing processes yet.
The presentation will address
Objective of PREFER
Changing environment
Patient preference study example
PREFER participants
PREFER project approach & status
About the Presenters
Conny Berlin, Global Head Quantitative Safety & Epidemiology,
Novartis International AG
Conny Berlin leads the Quantitative Safety & Epidemiology group at Novartis International AG. She holds a degree in mathematics from the University of Rostock, Germany and has more than 25 years of experience within the pharmaceutical industry.
Conny Berlin has a profound knowledge of quantitative methodology as applied to clinical and observational data and to spontaneous reports to respond to safety and benefit-risk questions during drug development and post-approval.
Conny Berlin is a member of the company’s internal Medical Safety Review Board and of the Real World Evidence Leadership Team.
She is well experienced in managing projects, leading and coordinating interdisciplinary teams. Conny Berlin is the industry project leader of the public-private IMI PREFER project.
Relevant references
Esther W. de Bekker-Grob, Conny Berlin et al. Giving Patients’ Preferences a Voice in Medical Treatment Life Cycle: The PREFER Public–Private Project. Patient: Editorial
Participant of the CIOMS working group X on "Evidence Synthesis and Meta-Analysis for Drug Safety"; report published in 2016
Berlin C, Blanch C et al. Are all quantitative postmarketing signal detection methods equal? Performance characteristics of logistic regression and Multi-item Gamma Poisson Shrinker. Pharmacoepidemiology and Drug Safety. 2011: 622-630
Rachael DiSantostefano, PhD, MS is a Director, Benefit-Risk in Epidemiology at Janssen R&D
Rachael L. DiSantostefano has nearly 25 years of pharmaceutical research experience across the quantitative disciplines of epidemiology, biostatistics, and health outcomes. She is currently responsible for guiding clinical teams in structured benefit-risk assessment, including the use of both qualitative and quantitative methods. She received her PhD in Health Policy and her Master’s degree in Biostatistics at the University of North Carolina Gillings School of Global Public Health. Prior to joining Janssen in 2015, she was an epidemiologist at another pharmaceutical company for 10 years, where she evaluated medication safety and contributed to benefit-risk assessment in regulatory submissions and at FDA Advisory Committee meetings. She is currently active as a task co-leader on the IMI PREFER project and an active member of the Benefit-Risk Assessment Communication and Evaluation Special Interest Group (BRACE-SIG) within the International Society for Pharmacoepidemiology.
In our 1-hour webinar on the 12 of July 2017 (4:30pm CET, 3:30pm BST, 10:30am EST) we will have a presentation by Conny Berlin who is the industry project leader of the public-private IMI PREFER project and Rachael DiSantostefano, a task co-leader on the IMI PREFER project.
Abstract
The main objective of the IMI PREFER project is to strengthen patient-centric decision making throughout the life cycle of medicinal products by developing evidence-based recommendations to guide industry, Regulatory Authorities, HTA bodies, reimbursement agencies, academia, and health care professionals on how and when patient-preference studies should be performed and the results used to support and inform decision making.
While over the last years all stakeholders gained experience individually how to engage patients for decision making this project aims to bring all stakeholders together taking a structured approach to determine their needs, expectations, and concerns regarding the use of patient-preference information and methodologies for patient-preference elicitation.
Methodologies for patient value elicitation are available and have been used frequently in market research, in health economics and outcomes research to substantiate real-life evidence. Further structured research has been done in projects like IMI PROTECT but there is no systematic use of these methodologies in the regulatory licensing processes yet.
The presentation will address
Objective of PREFER
Changing environment
Patient preference study example
PREFER participants
PREFER project approach & status
About the Presenters
Conny Berlin, Global Head Quantitative Safety & Epidemiology,
Novartis International AG
Conny Berlin leads the Quantitative Safety & Epidemiology group at Novartis International AG. She holds a degree in mathematics from the University of Rostock, Germany and has more than 25 years of experience within the pharmaceutical industry.
Conny Berlin has a profound knowledge of quantitative methodology as applied to clinical and observational data and to spontaneous reports to respond to safety and benefit-risk questions during drug development and post-approval.
Conny Berlin is a member of the company’s internal Medical Safety Review Board and of the Real World Evidence Leadership Team.
She is well experienced in managing projects, leading and coordinating interdisciplinary teams. Conny Berlin is the industry project leader of the public-private IMI PREFER project.
Relevant references
Esther W. de Bekker-Grob, Conny Berlin et al. Giving Patients’ Preferences a Voice in Medical Treatment Life Cycle: The PREFER Public–Private Project. Patient: Editorial
Participant of the CIOMS working group X on "Evidence Synthesis and Meta-Analysis for Drug Safety"; report published in 2016
Berlin C, Blanch C et al. Are all quantitative postmarketing signal detection methods equal? Performance characteristics of logistic regression and Multi-item Gamma Poisson Shrinker. Pharmacoepidemiology and Drug Safety. 2011: 622-630
Rachael DiSantostefano, PhD, MS is a Director, Benefit-Risk in Epidemiology at Janssen R&D
Rachael L. DiSantostefano has nearly 25 years of pharmaceutical research experience across the quantitative disciplines of epidemiology, biostatistics, and health outcomes. She is currently responsible for guiding clinical teams in structured benefit-risk assessment, including the use of both qualitative and quantitative methods. She received her PhD in Health Policy and her Master’s degree in Biostatistics at the University of North Carolina Gillings School of Global Public Health. Prior to joining Janssen in 2015, she was an epidemiologist at another pharmaceutical company for 10 years, where she evaluated medication safety and contributed to benefit-risk assessment in regulatory submissions and at FDA Advisory Committee meetings. She is currently active as a task co-leader on the IMI PREFER project and an active member of the Benefit-Risk Assessment Communication and Evaluation Special Interest Group (BRACE-SIG) within the International Society for Pharmacoepidemiology.
In our 1-hour webinar on the 12 of July 2017 (4:30pm CET, 3:30pm BST, 10:30am EST) we will have a presentation by Conny Berlin who is the industry project leader of the public-private IMI PREFER project and Rachael DiSantostefano, a task co-leader on the IMI PREFER project.
Abstract
The main objective of the IMI PREFER project is to strengthen patient-centric decision making throughout the life cycle of medicinal products by developing evidence-based recommendations to guide industry, Regulatory Authorities, HTA bodies, reimbursement agencies, academia, and health care professionals on how and when patient-preference studies should be performed and the results used to support and inform decision making.
While over the last years all stakeholders gained experience individually how to engage patients for decision making this project aims to bring all stakeholders together taking a structured approach to determine their needs, expectations, and concerns regarding the use of patient-preference information and methodologies for patient-preference elicitation.
Methodologies for patient value elicitation are available and have been used frequently in market research, in health economics and outcomes research to substantiate real-life evidence. Further structured research has been done in projects like IMI PROTECT but there is no systematic use of these methodologies in the regulatory licensing processes yet.
The presentation will address
Objective of PREFER
Changing environment
Patient preference study example
PREFER participants
PREFER project approach & status
About the Presenters
Conny Berlin, Global Head Quantitative Safety & Epidemiology,
Novartis International AG
Conny Berlin leads the Quantitative Safety & Epidemiology group at Novartis International AG. She holds a degree in mathematics from the University of Rostock, Germany and has more than 25 years of experience within the pharmaceutical industry.
Conny Berlin has a profound knowledge of quantitative methodology as applied to clinical and observational data and to spontaneous reports to respond to safety and benefit-risk questions during drug development and post-approval.
Conny Berlin is a member of the company’s internal Medical Safety Review Board and of the Real World Evidence Leadership Team.
She is well experienced in managing projects, leading and coordinating interdisciplinary teams. Conny Berlin is the industry project leader of the public-private IMI PREFER project.
Relevant references
Esther W. de Bekker-Grob, Conny Berlin et al. Giving Patients’ Preferences a Voice in Medical Treatment Life Cycle: The PREFER Public–Private Project. Patient: Editorial
Participant of the CIOMS working group X on "Evidence Synthesis and Meta-Analysis for Drug Safety"; report published in 2016
Berlin C, Blanch C et al. Are all quantitative postmarketing signal detection methods equal? Performance characteristics of logistic regression and Multi-item Gamma Poisson Shrinker. Pharmacoepidemiology and Drug Safety. 2011: 622-630
Rachael DiSantostefano, PhD, MS is a Director, Benefit-Risk in Epidemiology at Janssen R&D
Rachael L. DiSantostefano has nearly 25 years of pharmaceutical research experience across the quantitative disciplines of epidemiology, biostatistics, and health outcomes. She is currently responsible for guiding clinical teams in structured benefit-risk assessment, including the use of both qualitative and quantitative methods. She received her PhD in Health Policy and her Master’s degree in Biostatistics at the University of North Carolina Gillings School of Global Public Health. Prior to joining Janssen in 2015, she was an epidemiologist at another pharmaceutical company for 10 years, where she evaluated medication safety and contributed to benefit-risk assessment in regulatory submissions and at FDA Advisory Committee meetings. She is currently active as a task co-leader on the IMI PREFER project and an active member of the Benefit-Risk Assessment Communication and Evaluation Special Interest Group (BRACE-SIG) within the International Society for Pharmacoepidemiology.
In our 1-hour webinar on the 12 of July 2017 (4:30pm CET, 3:30pm BST, 10:30am EST) we will have a presentation by Conny Berlin who is the industry project leader of the public-private IMI PREFER project and Rachael DiSantostefano, a task co-leader on the IMI PREFER project.
Abstract
The main objective of the IMI PREFER project is to strengthen patient-centric decision making throughout the life cycle of medicinal products by developing evidence-based recommendations to guide industry, Regulatory Authorities, HTA bodies, reimbursement agencies, academia, and health care professionals on how and when patient-preference studies should be performed and the results used to support and inform decision making.
While over the last years all stakeholders gained experience individually how to engage patients for decision making this project aims to bring all stakeholders together taking a structured approach to determine their needs, expectations, and concerns regarding the use of patient-preference information and methodologies for patient-preference elicitation.
Methodologies for patient value elicitation are available and have been used frequently in market research, in health economics and outcomes research to substantiate real-life evidence. Further structured research has been done in projects like IMI PROTECT but there is no systematic use of these methodologies in the regulatory licensing processes yet.
The presentation will address
Objective of PREFER
Changing environment
Patient preference study example
PREFER participants
PREFER project approach & status
About the Presenters
Conny Berlin, Global Head Quantitative Safety & Epidemiology,
Novartis International AG
Conny Berlin leads the Quantitative Safety & Epidemiology group at Novartis International AG. She holds a degree in mathematics from the University of Rostock, Germany and has more than 25 years of experience within the pharmaceutical industry.
Conny Berlin has a profound knowledge of quantitative methodology as applied to clinical and observational data and to spontaneous reports to respond to safety and benefit-risk questions during drug development and post-approval.
Conny Berlin is a member of the company’s internal Medical Safety Review Board and of the Real World Evidence Leadership Team.
She is well experienced in managing projects, leading and coordinating interdisciplinary teams. Conny Berlin is the industry project leader of the public-private IMI PREFER project.
Relevant references
Esther W. de Bekker-Grob, Conny Berlin et al. Giving Patients’ Preferences a Voice in Medical Treatment Life Cycle: The PREFER Public–Private Project. Patient: Editorial
Participant of the CIOMS working group X on "Evidence Synthesis and Meta-Analysis for Drug Safety"; report published in 2016
Berlin C, Blanch C et al. Are all quantitative postmarketing signal detection methods equal? Performance characteristics of logistic regression and Multi-item Gamma Poisson Shrinker. Pharmacoepidemiology and Drug Safety. 2011: 622-630
Rachael DiSantostefano, PhD, MS is a Director, Benefit-Risk in Epidemiology at Janssen R&D
Rachael L. DiSantostefano has nearly 25 years of pharmaceutical research experience across the quantitative disciplines of epidemiology, biostatistics, and health outcomes. She is currently responsible for guiding clinical teams in structured benefit-risk assessment, including the use of both qualitative and quantitative methods. She received her PhD in Health Policy and her Master’s degree in Biostatistics at the University of North Carolina Gillings School of Global Public Health. Prior to joining Janssen in 2015, she was an epidemiologist at another pharmaceutical company for 10 years, where she evaluated medication safety and contributed to benefit-risk assessment in regulatory submissions and at FDA Advisory Committee meetings. She is currently active as a task co-leader on the IMI PREFER project and an active member of the Benefit-Risk Assessment Communication and Evaluation Special Interest Group (BRACE-SIG) within the International Society for Pharmacoepidemiology.
PSI Training Course: Effective Leadership – the keys to growing your leadership capabilities
This course will consist of three online half-day workshops. The first will be aimed at building trust, the backbone of leadership and a key to becoming effective. This is key to building a solid foundation.
The second will be on improving communication as a technical leader. This workshop will focus on communication strategies for different stakeholders and will involve tips on effective communication and how to develop the skills of active listening, coaching and what improv can teach us about good communication.
The final workshop will bring these two components together to help leaders become more influential. This will also focus on how to use Steven Covey’s 7-Habits, in particular Habits 4, 5 and 6, which are called the habits of communication.
The workshops will be interactive, allowing you to practice the concepts discussed. There will be plenty of time for questions and discussion. There will also be reflective time where you can think about what you are learning and how you might experiment with it.
PSI Introduction to Industry Training (ITIT) Course - 2026/2027
An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
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Our monthly webinar series allows attendees to gain practical knowledge and skills in open-source coding and tools, with a focus on applications in the pharmaceutical industry. This month’s session, “Graphics Basics,” will introduce the fundamentals of producing graphics using the ggplot2 package.
Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars
Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.
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Statisticians in the Age of AI: On Route to Strategic Partnership
A 90-minute webinar featuring two case studies from Bayer and Roche demonstrating how statisticians successfully integrated into AI programs, followed by interactive discussion on strategies for elevating statistical expertise in the AI era.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
GSK - Statistics Director - Vaccines and Infectious Disease
We are seeking an experienced and visionary Statistics Director to join our Team and lead strategic statistical innovation across GSK’s Vaccines and Infectious Disease portfolio.
As a Senior Biostatistician I at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
As a Statistical Scientist at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
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: We have an exciting opportunity for an Associate Director (AD), Statistical Programming, to join a passionate team within Advanced Quantitative Sciences- Development.
Novartis - Senior Principal Statistical Programmer
We have an exciting opportunity for a Senior Principal Statistical Programmer, to join a passionate team within Advanced Quantitative Sciences – Development.
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We are seeking a highly skilled and proactive Clinical Development Safety Statistics Expert to join our Biometry Department and the Biometry Leadership Team based in Toulouse (31, Oncopole) or Boulogne (92).
Pierre Fabre - Lead Statistician – Real World Evidence -CDI- M/F
Pierre Fabre Laboratories are hiring a highly skilled and experienced Lead Statistician – Real World Evidence (RWE) to join the Biometry Department, part of the Data Science & Biometry Department, based in Toulouse (Oncopôle) or Boulogne.
Pierre Fabre - Lead Statistician- Clinical Trials M/F
We are seeking a highly skilled and experienced Lead Statistician in Clinical Trials to join our Biometry Department based in Toulouse (31, Oncopole) or Boulogne (92).
We are looking for Senior Statistical Programmers in the UK to join Veramed, where you'll deliver high-impact programming solutions in an FSP-style capacity, while advancing your career in a supportive, growth-driven environment.