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.
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
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
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.
To access the recording, please visit the Video-on-Demand Library.
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.
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
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
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.
To access the recording, please visit the Video-on-Demand Library.
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.
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
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
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.
To access the recording, please visit the Video-on-Demand Library.
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.
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
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
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.
To access the recording, please visit the Video-on-Demand Library.
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.
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
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
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.
To access the recording, please visit the Video-on-Demand Library.
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.
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
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
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.
To access the recording, please visit the Video-on-Demand Library.
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.
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.
The book club’s usual focus is to read and discuss professional development books. In this short format event you can more easily develop you career without the commitment of reading the whole book - simply listen to the 1-hour long podcast before joining the interactive session on 21 May.
This webinar is organised by the RWD SIG and the Historical Data SIG. We will review recent methods, applications, and tools of integrating subject-level-data from clinical trial with external data using Bayesian methods and/or causal inference methods.
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 will be a 45 minute webinar which will explain the topic presented in the published paper, ‘Applying the Estimand Framework to Clinical Pharmacology Trials with a Case Study in Bioequivalance’. There will be 15 minutes for a panel Q&A with some of the authors following the presentation.
This 1-hour webinar will be an opportunity to hear about the methodology and first results of the iRISE consortium. iRISE is working towards a better understanding of reproducibility and the interventions that work to improve it. At the end of the presentation there will also be the opportunity to ask questions.
This one-day event focuses on the comprehensive management of transitioning to R/Open-Source, addressing the challenges and providing actionable insights. Attendees will participate in sessions covering essential topics such as training best practices, creating strategic plans, making the case to senior management, and managing both statistical and programming aspects of the transition.
Develop your non-technical skills by reading The Art of Explanation by Ros Atkins and joining the Sept-Dec 2025 book club. You will be invited to join facilitated discussions of the concepts and ideas and apply skills from the book in-between sessions.
This course is aimed at biostatisticians with no or some pediatric drug development experience who are interested to further their understanding. We will give you an introduction to the pediatric drug development landscape. This will include identifying the key regulations and processes governing pediatric development, a discussion on the needs and challenges when conducting pediatric research and a focus on the ways to overcome these challenges from a statistical perspective.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
The program will feature insightful sessions led by distinguished invited speakers, alongside a poster session showcasing the latest advancements in the field. Further details will be provided.
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 is an exciting, new opportunity for an experienced Statistician looking to take the next step in their career. Offered as a remote or hybrid position aligned with our site in Harrogate, North Yorkshire.
About cookies on this site
We use cookies to collect and analyse information on site performance and usage, to provide social media features and to enhance and customise content and advertisements.
About cookies on this site
Cookies used on the site are categorized and below you can read about each category and allow or deny some or all of them. When categories than have been previously allowed are disabled, all cookies assigned to that category will be removed from your browser. Additionally you can see a list of cookies assigned to each category and detailed information in the cookie declaration.
Necessary cookies
Some cookies are required to provide core functionality. The website won't function properly without these cookies and they are enabled by default and cannot be disabled.
CookieHub is a Consent Management Platform (CMP) which allows users to control storage and processing of personal information.
Cloudflare is a global network designed to make everything you connect to the Internet secure, private, fast, and reliable.
Amazon Web Services offers a broad set of global cloud-based products including compute, storage, databases, analytics, networking, mobile, developer tools, management tools, IoT, security, and enterprise applications.
Microsoft Azure is a cloud computing platform offering a wide range of services, including virtual machines, databases, and AI tools.
Preferences
Preference cookies enables the web site to remember information to customize how the web site looks or behaves for each user. This may include storing selected currency, region, language or color theme.
Analytical cookies
Analytical cookies help us improve our website by collecting and reporting information on its usage.
Google Analytics is a web analytics service offered by Google that tracks and reports website traffic.
Vimeo, Inc. is an American video hosting, sharing, services provider, and broadcaster. Vimeo focuses on the delivery of high-definition video across a range of devices.
Cookies used on the site are categorized and below you can read about each category and allow or deny some or all of them. When categories than have been previously allowed are disabled, all cookies assigned to that category will be removed from your browser. Additionally you can see a list of cookies assigned to each category and detailed information in the cookie declaration.
Necessary cookies
Some cookies are required to provide core functionality. The website won't function properly without these cookies and they are enabled by default and cannot be disabled.
| Name | Hostname | Vendor | Expiry |
|---|---|---|---|
| ARRAffinity | .psiweb.org | Session | |
This cookie is set by websites run on the Windows Azure cloud platform. It is used for load balancing to make sure the visitor page requests are routed to the same server in any browsing session. | |||
| ARRAffinitySameSite | .psiweb.org | Session | |
Used to distribute traffic to the website on several servers in order to optimize response times. | |||
| __cf_bm | .vimeo.com | Cloudflare, Inc. | 1 hour |
The __cf_bm cookie supports Cloudflare Bot Management by managing incoming traffic that matches criteria associated with bots. The cookie does not collect any personal data, and any information collected is subject to one-way encryption. | |||
| _cfuvid | .vimeo.com | Session | |
Used by Cloudflare WAF to distinguish individual users who share the same IP address and apply rate limits | |||
| __cf_bm | .glueup.com | Cloudflare, Inc. | 1 hour |
The __cf_bm cookie supports Cloudflare Bot Management by managing incoming traffic that matches criteria associated with bots. The cookie does not collect any personal data, and any information collected is subject to one-way encryption. | |||
| AWSALBTGCORS | psi.glueup.com | 7 days | |
AWS Classic Load Balancer Cookie: Load Balancing Cookie: Used to map the session to the instance. Same value as AWSELB. | |||
| PHPSESSID | psi.glueup.com | Session | |
Cookie generated by applications based on the PHP language. This is a general purpose identifier used to maintain user session variables. It is normally a random generated number, how it is used can be specific to the site, but a good example is maintaining a logged-in status for a user between pages. | |||
| History.store | Session | ||
| cookiehub | .psiweb.org | CookieHub | 365 days |
Used by CookieHub to store information about whether visitors have given or declined the use of cookie categories used on the site. | |||
Preferences
Preference cookies enables the web site to remember information to customize how the web site looks or behaves for each user. This may include storing selected currency, region, language or color theme.
| Name | Hostname | Vendor | Expiry |
|---|---|---|---|
| vuid | .vimeo.com | 400 days | |
These cookies are used by the Vimeo video player on websites. | |||
| AWSALBCORS | psi.glueup.com | 7 days | |
Amazon Web Services cookie. This cookie enables us to allocate server traffic to make the user experience as smooth as possible. A so-called load balancer is used to determine which server currently has the best availability. The information generated cannot identify you as an individual. | |||
Analytical cookies
Analytical cookies help us improve our website by collecting and reporting information on its usage.
| Name | Hostname | Vendor | Expiry |
|---|---|---|---|
| _ga_ | .psiweb.org | 400 days | |
Contains a unique identifier used by Google Analytics 4 to determine that two distinct hits belong to the same user across browsing sessions. | |||
| _ga | .psiweb.org | 400 days | |
Contains a unique identifier used by Google Analytics to determine that two distinct hits belong to the same user across browsing sessions. | |||
