Date: Friday 24th November 2023 Time: 09:50-17:00 GMT (registration from 09:15) Location: Windsor Rooms, Johnson & Johnson, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG Speakers: Julia Saperia (MHRA), Kim Lee (Kings College London), Tobias Mielke (Janssen), David Robertson (MRC Biostatistics Unit), Luke Ouma (Newcastle Universit), Elias Meyer (Berry Consultants), Adrian Mander (GSK), Vincent Haddad (AstraZeneca), Cindy Billingham (Birmingham University), and Willem Talloen (Janssen).
Who is this event intended for? All parties interested in the use of master protocols in clinical research, in particular but not only statisticians. What is the benefit of attending? This one-day event will establish a forum to engage with colleagues from a diverse range of backgrounds who are actively working on effective master protocol design, analysis, and execution. It will provide the opportunity to learn much about the current landscape of master protocol use.
Overview
This meeting will bring together cross-sector researchers to provide talks on innovative methodology for the design and analysis of basket, umbrella, and platform trials. Additional presentations will address learnings from practical examples of master protocols and regulatory opinions on their implementation.
Speaker details
Our Speaker line-up is featured below, but you can also download a full overview of the event Agenda, Speaker Biographies, Speaker Abstracts and travel details which have been compiled into a single PDF for ease. Please click below to view or download a copy for more information. Event PDF: Master Protocols - Overview
Date: Friday 24th November 2023 Time: 09:50-17:00 GMT (registration from 09:15) Location: Windsor Rooms, Johnson & Johnson, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG Speakers: Julia Saperia (MHRA), Kim Lee (Kings College London), Tobias Mielke (Janssen), David Robertson (MRC Biostatistics Unit), Luke Ouma (Newcastle Universit), Elias Meyer (Berry Consultants), Adrian Mander (GSK), Vincent Haddad (AstraZeneca), Cindy Billingham (Birmingham University), and Willem Talloen (Janssen).
Who is this event intended for? All parties interested in the use of master protocols in clinical research, in particular but not only statisticians. What is the benefit of attending? This one-day event will establish a forum to engage with colleagues from a diverse range of backgrounds who are actively working on effective master protocol design, analysis, and execution. It will provide the opportunity to learn much about the current landscape of master protocol use.
Overview
This meeting will bring together cross-sector researchers to provide talks on innovative methodology for the design and analysis of basket, umbrella, and platform trials. Additional presentations will address learnings from practical examples of master protocols and regulatory opinions on their implementation.
Speaker details
Our Speaker line-up is featured below, but you can also download a full overview of the event Agenda, Speaker Biographies, Speaker Abstracts and travel details which have been compiled into a single PDF for ease. Please click below to view or download a copy for more information. Event PDF: Master Protocols - Overview
Date: Friday 24th November 2023 Time: 09:50-17:00 GMT (registration from 09:15) Location: Windsor Rooms, Johnson & Johnson, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG Speakers: Julia Saperia (MHRA), Kim Lee (Kings College London), Tobias Mielke (Janssen), David Robertson (MRC Biostatistics Unit), Luke Ouma (Newcastle Universit), Elias Meyer (Berry Consultants), Adrian Mander (GSK), Vincent Haddad (AstraZeneca), Cindy Billingham (Birmingham University), and Willem Talloen (Janssen).
Who is this event intended for? All parties interested in the use of master protocols in clinical research, in particular but not only statisticians. What is the benefit of attending? This one-day event will establish a forum to engage with colleagues from a diverse range of backgrounds who are actively working on effective master protocol design, analysis, and execution. It will provide the opportunity to learn much about the current landscape of master protocol use.
Overview
This meeting will bring together cross-sector researchers to provide talks on innovative methodology for the design and analysis of basket, umbrella, and platform trials. Additional presentations will address learnings from practical examples of master protocols and regulatory opinions on their implementation.
Speaker details
Our Speaker line-up is featured below, but you can also download a full overview of the event Agenda, Speaker Biographies, Speaker Abstracts and travel details which have been compiled into a single PDF for ease. Please click below to view or download a copy for more information. Event PDF: Master Protocols - Overview
Date: Friday 24th November 2023 Time: 09:50-17:00 GMT (registration from 09:15) Location: Windsor Rooms, Johnson & Johnson, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG Speakers: Julia Saperia (MHRA), Kim Lee (Kings College London), Tobias Mielke (Janssen), David Robertson (MRC Biostatistics Unit), Luke Ouma (Newcastle Universit), Elias Meyer (Berry Consultants), Adrian Mander (GSK), Vincent Haddad (AstraZeneca), Cindy Billingham (Birmingham University), and Willem Talloen (Janssen).
Who is this event intended for? All parties interested in the use of master protocols in clinical research, in particular but not only statisticians. What is the benefit of attending? This one-day event will establish a forum to engage with colleagues from a diverse range of backgrounds who are actively working on effective master protocol design, analysis, and execution. It will provide the opportunity to learn much about the current landscape of master protocol use.
Overview
This meeting will bring together cross-sector researchers to provide talks on innovative methodology for the design and analysis of basket, umbrella, and platform trials. Additional presentations will address learnings from practical examples of master protocols and regulatory opinions on their implementation.
Speaker details
Our Speaker line-up is featured below, but you can also download a full overview of the event Agenda, Speaker Biographies, Speaker Abstracts and travel details which have been compiled into a single PDF for ease. Please click below to view or download a copy for more information. Event PDF: Master Protocols - Overview
Date: Friday 24th November 2023 Time: 09:50-17:00 GMT (registration from 09:15) Location: Windsor Rooms, Johnson & Johnson, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG Speakers: Julia Saperia (MHRA), Kim Lee (Kings College London), Tobias Mielke (Janssen), David Robertson (MRC Biostatistics Unit), Luke Ouma (Newcastle Universit), Elias Meyer (Berry Consultants), Adrian Mander (GSK), Vincent Haddad (AstraZeneca), Cindy Billingham (Birmingham University), and Willem Talloen (Janssen).
Who is this event intended for? All parties interested in the use of master protocols in clinical research, in particular but not only statisticians. What is the benefit of attending? This one-day event will establish a forum to engage with colleagues from a diverse range of backgrounds who are actively working on effective master protocol design, analysis, and execution. It will provide the opportunity to learn much about the current landscape of master protocol use.
Overview
This meeting will bring together cross-sector researchers to provide talks on innovative methodology for the design and analysis of basket, umbrella, and platform trials. Additional presentations will address learnings from practical examples of master protocols and regulatory opinions on their implementation.
Speaker details
Our Speaker line-up is featured below, but you can also download a full overview of the event Agenda, Speaker Biographies, Speaker Abstracts and travel details which have been compiled into a single PDF for ease. Please click below to view or download a copy for more information. Event PDF: Master Protocols - Overview
Date: Friday 24th November 2023 Time: 09:50-17:00 GMT (registration from 09:15) Location: Windsor Rooms, Johnson & Johnson, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG Speakers: Julia Saperia (MHRA), Kim Lee (Kings College London), Tobias Mielke (Janssen), David Robertson (MRC Biostatistics Unit), Luke Ouma (Newcastle Universit), Elias Meyer (Berry Consultants), Adrian Mander (GSK), Vincent Haddad (AstraZeneca), Cindy Billingham (Birmingham University), and Willem Talloen (Janssen).
Who is this event intended for? All parties interested in the use of master protocols in clinical research, in particular but not only statisticians. What is the benefit of attending? This one-day event will establish a forum to engage with colleagues from a diverse range of backgrounds who are actively working on effective master protocol design, analysis, and execution. It will provide the opportunity to learn much about the current landscape of master protocol use.
Overview
This meeting will bring together cross-sector researchers to provide talks on innovative methodology for the design and analysis of basket, umbrella, and platform trials. Additional presentations will address learnings from practical examples of master protocols and regulatory opinions on their implementation.
Speaker details
Our Speaker line-up is featured below, but you can also download a full overview of the event Agenda, Speaker Biographies, Speaker Abstracts and travel details which have been compiled into a single PDF for ease. Please click below to view or download a copy for more information. Event PDF: Master Protocols - Overview
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.
PSI Webinar: Development of Gene Therapies: Strategic, Scientific, Regulatory and Access Considerations
This webinar will cover the history of cell/gene therapy, major regulatory advances, the role of quantitative scientists in drug development of these novel therapeutics, and discuss opportunities for innovation and product advancement.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
PSI Introduction to Industry Training (ITIT) Course - 2024/2025
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.
PSI Training Course: Regulatory Guidelines for Statisticians
This 2-day course is designed to provide a comprehensive understanding of the regulatory guidelines affecting statisticians in the pharmaceutical industry, including the latest updates in the field. The course will cover key International Council for Harmonisation (ICH) guidelines and other key regional regulatory agency documents.
Joint PSI/EFSPI Pre-Clinical SIG Webinar: Virtual Control Groups in Toxicity Studies
Lea Vaas will present how replacement of concurrent control animals by Virtual Control Groups (VCGs) in systemic toxicity studies may help in contributing to the 3R's principle of animal experimentation: Reduce, Refine, Replace.
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 apprenticeship role offers a unique opportunity to learn and work in a global healthcare consultancy company alongside a team of statisticians, psychometricians and programmers.
Statisticians in the Pharmaceutical Industry Executive Office: c/o MCI UK Ltd | Unit 24/22 South | Building 4000 | Langstone Park| Langstone Road | Havant | PO9 1SA | UK