Date: Wednesday 2nd & Thursday 3rd October 2024
Time: Day 1: 09:00-17:00 | Day 2: 09:00-16:00 BST
Location: This Course will be taught in-person, at Crowne Plaza London Heathrow T4 (Terminal 4, Swindon Road, Hounslow, TW6 3FJ, United Kingdom)
Speakers: Dan Evans (DMK2 Consulting Limited), Ines Antunes dos Reis (MHRA), Yolanda Barbachano (BioNTech) and Kerry Gordon (Phastar).
Who is this event intended for? Statisticians who would like to enhance their knowledge of the latest ICH and other global and regional regulatory guidelines.
What is the benefit of attending? Participants will either gain or expand upon their knowledge and awareness of the regulatory environment and associated guidelines.
Early Bird PSI Members = £370+VAT
PSI Members = £410+VAT
Early Bird Non-Members = £480+VAT
Non-Members = £520+VAT
*Please note: Non-Member rates include PSI membership until 31 Dec. 2025.
To book your place, please click here.
Please note:
- There are a limited number of places for this in-person event. Due to its popularity, we do kindly ask you to consider both the timings and location before committing to attend.
- Registration does not include hotel accommodation. If a hotel is required (as this Course runs over two consecutive days), delegates will need to book their own accommodation separately. As the Course is being held at the Crowne Plaza London Heathrow T4, we recommend booking your accommodation here. Additionally, there is a daily charge for parking, which can also be booked with the Reservations team. To make your booking, please contact the Crowne Plaza reservations team via the following:
Email: Reservations5@cpheathrowt4.com
Telephone: 0203 971 4182 or 0203 971 4181
The course will describe key ICH guidelines of main interest to statisticians, as well as guidance documents from regulatory bodies such as EMA, FDA, PMDA, MHRA and CDE. The focus of the course will be on the content of ICH E9 (Statistical Principles for Clinical Trials), ICH E9(R1) (Estimands and Sensitivity Analysis in Clinical Trials), ICH E10 (Choice of Control Group in Clinical Trials), ICH E6 (Good Clinical Practice), ICH E17 (Multi-Regional Clinical Trials), and ICH E20 (Adaptive Clinical Trials), but other key regulatory guidance documents will also be highlighted. The course will also include workshops, a Q&A session and guidance on how to seek advice from regulators.
|
Speaker |
Biography |
 Dan Evans |
Dan Evans has worked for Pfizer for over 30 years in a variety of statistical and team leadership roles leading the global development of medicines across many therapeutic areas. He has a particular focus on statistical regulatory topics and has been an active member of the PSI/EFSPI Regulatory Special Interest Group for over 15 years, participating in the co-ordination of reviews of new regulatory guidelines and policies and engagement on statistical topics with regulatory statisticians. He’s currently working as an independent statistical consultant. |
|
|
Inês has been a statistical assessor at the Medicines and Healthcare products Regulatory Agency (MHRA) since 2018. Her work focuses on assessment of marketing authorisation applications, providing scientific advice to companies, assessment of clinical investigation applications, and participating in the development of regulatory guidelines. She has over 7 years of experience in the regulatory system, having previously worked for the European Medicines Agency (EMA). She supported the ICH E9(R1) expert working group on Estimands and Sensitivity Analysis in Clinical Trials and contributed to the E9(R1) training materials published in the ICH website. |
|
|
Yolanda has worked as a statistician for nearly two decades, her experience spans from academia to regulatory bodies and now industry. Her interest in regulatory guidance developed whilst working over 10 years as a statistical assessor at the MHRA, and as part of the EMA system. Yolanda now works at BioNTech where she has to consider regulatory requirements for other regions. She has a PhD in statistics and a BSc in mathematics, both from the University of Sussex. |
|
|
Kerry Gordon has been in the health sector for over 40 years, mostly in the world of statistics and programming. As a past Chair of PSI, Kerry has sat on the PSI Board of Directors and has also served on the PSI Scientific, Website, Regulatory and Training subcommittees. After starting out with the NHS, he moved into the industry at (what is now) Novartis. Then, after a spell at the University of Kent, he worked for Quintiles (latterly IQVIA) for over 20 years and at Parexel for a few years. Kerry joined PHASTAR, a niche Biometrics CRO, in July last year as an Engagement Head, looking after specific customer accounts. |
Date: Wednesday 2nd & Thursday 3rd October 2024
Time: Day 1: 09:00-17:00 | Day 2: 09:00-16:00 BST
Location: This Course will be taught in-person, at Crowne Plaza London Heathrow T4 (Terminal 4, Swindon Road, Hounslow, TW6 3FJ, United Kingdom)
Speakers: Dan Evans (DMK2 Consulting Limited), Ines Antunes dos Reis (MHRA), Yolanda Barbachano (BioNTech) and Kerry Gordon (Phastar).
Who is this event intended for? Statisticians who would like to enhance their knowledge of the latest ICH and other global and regional regulatory guidelines.
What is the benefit of attending? Participants will either gain or expand upon their knowledge and awareness of the regulatory environment and associated guidelines.
Early Bird PSI Members = £370+VAT
PSI Members = £410+VAT
Early Bird Non-Members = £480+VAT
Non-Members = £520+VAT
*Please note: Non-Member rates include PSI membership until 31 Dec. 2025.
To book your place, please click here.
Please note:
- There are a limited number of places for this in-person event. Due to its popularity, we do kindly ask you to consider both the timings and location before committing to attend.
- Registration does not include hotel accommodation. If a hotel is required (as this Course runs over two consecutive days), delegates will need to book their own accommodation separately. As the Course is being held at the Crowne Plaza London Heathrow T4, we recommend booking your accommodation here. Additionally, there is a daily charge for parking, which can also be booked with the Reservations team. To make your booking, please contact the Crowne Plaza reservations team via the following:
Email: Reservations5@cpheathrowt4.com
Telephone: 0203 971 4182 or 0203 971 4181
The course will describe key ICH guidelines of main interest to statisticians, as well as guidance documents from regulatory bodies such as EMA, FDA, PMDA, MHRA and CDE. The focus of the course will be on the content of ICH E9 (Statistical Principles for Clinical Trials), ICH E9(R1) (Estimands and Sensitivity Analysis in Clinical Trials), ICH E10 (Choice of Control Group in Clinical Trials), ICH E6 (Good Clinical Practice), ICH E17 (Multi-Regional Clinical Trials), and ICH E20 (Adaptive Clinical Trials), but other key regulatory guidance documents will also be highlighted. The course will also include workshops, a Q&A session and guidance on how to seek advice from regulators.
|
Speaker |
Biography |
Dan Evans |
Dan Evans has worked for Pfizer for over 30 years in a variety of statistical and team leadership roles leading the global development of medicines across many therapeutic areas. He has a particular focus on statistical regulatory topics and has been an active member of the PSI/EFSPI Regulatory Special Interest Group for over 15 years, participating in the co-ordination of reviews of new regulatory guidelines and policies and engagement on statistical topics with regulatory statisticians. He’s currently working as an independent statistical consultant. |
|
|
Inês has been a statistical assessor at the Medicines and Healthcare products Regulatory Agency (MHRA) since 2018. Her work focuses on assessment of marketing authorisation applications, providing scientific advice to companies, assessment of clinical investigation applications, and participating in the development of regulatory guidelines. She has over 7 years of experience in the regulatory system, having previously worked for the European Medicines Agency (EMA). She supported the ICH E9(R1) expert working group on Estimands and Sensitivity Analysis in Clinical Trials and contributed to the E9(R1) training materials published in the ICH website. |
|
|
Yolanda has worked as a statistician for nearly two decades, her experience spans from academia to regulatory bodies and now industry. Her interest in regulatory guidance developed whilst working over 10 years as a statistical assessor at the MHRA, and as part of the EMA system. Yolanda now works at BioNTech where she has to consider regulatory requirements for other regions. She has a PhD in statistics and a BSc in mathematics, both from the University of Sussex. |
|
|
Kerry Gordon has been in the health sector for over 40 years, mostly in the world of statistics and programming. As a past Chair of PSI, Kerry has sat on the PSI Board of Directors and has also served on the PSI Scientific, Website, Regulatory and Training subcommittees. After starting out with the NHS, he moved into the industry at (what is now) Novartis. Then, after a spell at the University of Kent, he worked for Quintiles (latterly IQVIA) for over 20 years and at Parexel for a few years. Kerry joined PHASTAR, a niche Biometrics CRO, in July last year as an Engagement Head, looking after specific customer accounts. |
Date: Wednesday 2nd & Thursday 3rd October 2024
Time: Day 1: 09:00-17:00 | Day 2: 09:00-16:00 BST
Location: This Course will be taught in-person, at Crowne Plaza London Heathrow T4 (Terminal 4, Swindon Road, Hounslow, TW6 3FJ, United Kingdom)
Speakers: Dan Evans (DMK2 Consulting Limited), Ines Antunes dos Reis (MHRA), Yolanda Barbachano (BioNTech) and Kerry Gordon (Phastar).
Who is this event intended for? Statisticians who would like to enhance their knowledge of the latest ICH and other global and regional regulatory guidelines.
What is the benefit of attending? Participants will either gain or expand upon their knowledge and awareness of the regulatory environment and associated guidelines.
Early Bird PSI Members = £370+VAT
PSI Members = £410+VAT
Early Bird Non-Members = £480+VAT
Non-Members = £520+VAT
*Please note: Non-Member rates include PSI membership until 31 Dec. 2025.
To book your place, please click here.
Please note:
- There are a limited number of places for this in-person event. Due to its popularity, we do kindly ask you to consider both the timings and location before committing to attend.
- Registration does not include hotel accommodation. If a hotel is required (as this Course runs over two consecutive days), delegates will need to book their own accommodation separately. As the Course is being held at the Crowne Plaza London Heathrow T4, we recommend booking your accommodation here. Additionally, there is a daily charge for parking, which can also be booked with the Reservations team. To make your booking, please contact the Crowne Plaza reservations team via the following:
Email: Reservations5@cpheathrowt4.com
Telephone: 0203 971 4182 or 0203 971 4181
The course will describe key ICH guidelines of main interest to statisticians, as well as guidance documents from regulatory bodies such as EMA, FDA, PMDA, MHRA and CDE. The focus of the course will be on the content of ICH E9 (Statistical Principles for Clinical Trials), ICH E9(R1) (Estimands and Sensitivity Analysis in Clinical Trials), ICH E10 (Choice of Control Group in Clinical Trials), ICH E6 (Good Clinical Practice), ICH E17 (Multi-Regional Clinical Trials), and ICH E20 (Adaptive Clinical Trials), but other key regulatory guidance documents will also be highlighted. The course will also include workshops, a Q&A session and guidance on how to seek advice from regulators.
|
Speaker |
Biography |
Dan Evans |
Dan Evans has worked for Pfizer for over 30 years in a variety of statistical and team leadership roles leading the global development of medicines across many therapeutic areas. He has a particular focus on statistical regulatory topics and has been an active member of the PSI/EFSPI Regulatory Special Interest Group for over 15 years, participating in the co-ordination of reviews of new regulatory guidelines and policies and engagement on statistical topics with regulatory statisticians. He’s currently working as an independent statistical consultant. |
|
|
Inês has been a statistical assessor at the Medicines and Healthcare products Regulatory Agency (MHRA) since 2018. Her work focuses on assessment of marketing authorisation applications, providing scientific advice to companies, assessment of clinical investigation applications, and participating in the development of regulatory guidelines. She has over 7 years of experience in the regulatory system, having previously worked for the European Medicines Agency (EMA). She supported the ICH E9(R1) expert working group on Estimands and Sensitivity Analysis in Clinical Trials and contributed to the E9(R1) training materials published in the ICH website. |
|
|
Yolanda has worked as a statistician for nearly two decades, her experience spans from academia to regulatory bodies and now industry. Her interest in regulatory guidance developed whilst working over 10 years as a statistical assessor at the MHRA, and as part of the EMA system. Yolanda now works at BioNTech where she has to consider regulatory requirements for other regions. She has a PhD in statistics and a BSc in mathematics, both from the University of Sussex. |
|
|
Kerry Gordon has been in the health sector for over 40 years, mostly in the world of statistics and programming. As a past Chair of PSI, Kerry has sat on the PSI Board of Directors and has also served on the PSI Scientific, Website, Regulatory and Training subcommittees. After starting out with the NHS, he moved into the industry at (what is now) Novartis. Then, after a spell at the University of Kent, he worked for Quintiles (latterly IQVIA) for over 20 years and at Parexel for a few years. Kerry joined PHASTAR, a niche Biometrics CRO, in July last year as an Engagement Head, looking after specific customer accounts. |
Date: Wednesday 2nd & Thursday 3rd October 2024
Time: Day 1: 09:00-17:00 | Day 2: 09:00-16:00 BST
Location: This Course will be taught in-person, at Crowne Plaza London Heathrow T4 (Terminal 4, Swindon Road, Hounslow, TW6 3FJ, United Kingdom)
Speakers: Dan Evans (DMK2 Consulting Limited), Ines Antunes dos Reis (MHRA), Yolanda Barbachano (BioNTech) and Kerry Gordon (Phastar).
Who is this event intended for? Statisticians who would like to enhance their knowledge of the latest ICH and other global and regional regulatory guidelines.
What is the benefit of attending? Participants will either gain or expand upon their knowledge and awareness of the regulatory environment and associated guidelines.
Early Bird PSI Members = £370+VAT
PSI Members = £410+VAT
Early Bird Non-Members = £480+VAT
Non-Members = £520+VAT
*Please note: Non-Member rates include PSI membership until 31 Dec. 2025.
To book your place, please click here.
Please note:
- There are a limited number of places for this in-person event. Due to its popularity, we do kindly ask you to consider both the timings and location before committing to attend.
- Registration does not include hotel accommodation. If a hotel is required (as this Course runs over two consecutive days), delegates will need to book their own accommodation separately. As the Course is being held at the Crowne Plaza London Heathrow T4, we recommend booking your accommodation here. Additionally, there is a daily charge for parking, which can also be booked with the Reservations team. To make your booking, please contact the Crowne Plaza reservations team via the following:
Email: Reservations5@cpheathrowt4.com
Telephone: 0203 971 4182 or 0203 971 4181
The course will describe key ICH guidelines of main interest to statisticians, as well as guidance documents from regulatory bodies such as EMA, FDA, PMDA, MHRA and CDE. The focus of the course will be on the content of ICH E9 (Statistical Principles for Clinical Trials), ICH E9(R1) (Estimands and Sensitivity Analysis in Clinical Trials), ICH E10 (Choice of Control Group in Clinical Trials), ICH E6 (Good Clinical Practice), ICH E17 (Multi-Regional Clinical Trials), and ICH E20 (Adaptive Clinical Trials), but other key regulatory guidance documents will also be highlighted. The course will also include workshops, a Q&A session and guidance on how to seek advice from regulators.
|
Speaker |
Biography |
Dan Evans |
Dan Evans has worked for Pfizer for over 30 years in a variety of statistical and team leadership roles leading the global development of medicines across many therapeutic areas. He has a particular focus on statistical regulatory topics and has been an active member of the PSI/EFSPI Regulatory Special Interest Group for over 15 years, participating in the co-ordination of reviews of new regulatory guidelines and policies and engagement on statistical topics with regulatory statisticians. He’s currently working as an independent statistical consultant. |
|
|
Inês has been a statistical assessor at the Medicines and Healthcare products Regulatory Agency (MHRA) since 2018. Her work focuses on assessment of marketing authorisation applications, providing scientific advice to companies, assessment of clinical investigation applications, and participating in the development of regulatory guidelines. She has over 7 years of experience in the regulatory system, having previously worked for the European Medicines Agency (EMA). She supported the ICH E9(R1) expert working group on Estimands and Sensitivity Analysis in Clinical Trials and contributed to the E9(R1) training materials published in the ICH website. |
|
|
Yolanda has worked as a statistician for nearly two decades, her experience spans from academia to regulatory bodies and now industry. Her interest in regulatory guidance developed whilst working over 10 years as a statistical assessor at the MHRA, and as part of the EMA system. Yolanda now works at BioNTech where she has to consider regulatory requirements for other regions. She has a PhD in statistics and a BSc in mathematics, both from the University of Sussex. |
|
|
Kerry Gordon has been in the health sector for over 40 years, mostly in the world of statistics and programming. As a past Chair of PSI, Kerry has sat on the PSI Board of Directors and has also served on the PSI Scientific, Website, Regulatory and Training subcommittees. After starting out with the NHS, he moved into the industry at (what is now) Novartis. Then, after a spell at the University of Kent, he worked for Quintiles (latterly IQVIA) for over 20 years and at Parexel for a few years. Kerry joined PHASTAR, a niche Biometrics CRO, in July last year as an Engagement Head, looking after specific customer accounts. |
Date: Wednesday 2nd & Thursday 3rd October 2024
Time: Day 1: 09:00-17:00 | Day 2: 09:00-16:00 BST
Location: This Course will be taught in-person, at Crowne Plaza London Heathrow T4 (Terminal 4, Swindon Road, Hounslow, TW6 3FJ, United Kingdom)
Speakers: Dan Evans (DMK2 Consulting Limited), Ines Antunes dos Reis (MHRA), Yolanda Barbachano (BioNTech) and Kerry Gordon (Phastar).
Who is this event intended for? Statisticians who would like to enhance their knowledge of the latest ICH and other global and regional regulatory guidelines.
What is the benefit of attending? Participants will either gain or expand upon their knowledge and awareness of the regulatory environment and associated guidelines.
Early Bird PSI Members = £370+VAT
PSI Members = £410+VAT
Early Bird Non-Members = £480+VAT
Non-Members = £520+VAT
*Please note: Non-Member rates include PSI membership until 31 Dec. 2025.
To book your place, please click here.
Please note:
- There are a limited number of places for this in-person event. Due to its popularity, we do kindly ask you to consider both the timings and location before committing to attend.
- Registration does not include hotel accommodation. If a hotel is required (as this Course runs over two consecutive days), delegates will need to book their own accommodation separately. As the Course is being held at the Crowne Plaza London Heathrow T4, we recommend booking your accommodation here. Additionally, there is a daily charge for parking, which can also be booked with the Reservations team. To make your booking, please contact the Crowne Plaza reservations team via the following:
Email: Reservations5@cpheathrowt4.com
Telephone: 0203 971 4182 or 0203 971 4181
The course will describe key ICH guidelines of main interest to statisticians, as well as guidance documents from regulatory bodies such as EMA, FDA, PMDA, MHRA and CDE. The focus of the course will be on the content of ICH E9 (Statistical Principles for Clinical Trials), ICH E9(R1) (Estimands and Sensitivity Analysis in Clinical Trials), ICH E10 (Choice of Control Group in Clinical Trials), ICH E6 (Good Clinical Practice), ICH E17 (Multi-Regional Clinical Trials), and ICH E20 (Adaptive Clinical Trials), but other key regulatory guidance documents will also be highlighted. The course will also include workshops, a Q&A session and guidance on how to seek advice from regulators.
|
Speaker |
Biography |
Dan Evans |
Dan Evans has worked for Pfizer for over 30 years in a variety of statistical and team leadership roles leading the global development of medicines across many therapeutic areas. He has a particular focus on statistical regulatory topics and has been an active member of the PSI/EFSPI Regulatory Special Interest Group for over 15 years, participating in the co-ordination of reviews of new regulatory guidelines and policies and engagement on statistical topics with regulatory statisticians. He’s currently working as an independent statistical consultant. |
|
|
Inês has been a statistical assessor at the Medicines and Healthcare products Regulatory Agency (MHRA) since 2018. Her work focuses on assessment of marketing authorisation applications, providing scientific advice to companies, assessment of clinical investigation applications, and participating in the development of regulatory guidelines. She has over 7 years of experience in the regulatory system, having previously worked for the European Medicines Agency (EMA). She supported the ICH E9(R1) expert working group on Estimands and Sensitivity Analysis in Clinical Trials and contributed to the E9(R1) training materials published in the ICH website. |
|
|
Yolanda has worked as a statistician for nearly two decades, her experience spans from academia to regulatory bodies and now industry. Her interest in regulatory guidance developed whilst working over 10 years as a statistical assessor at the MHRA, and as part of the EMA system. Yolanda now works at BioNTech where she has to consider regulatory requirements for other regions. She has a PhD in statistics and a BSc in mathematics, both from the University of Sussex. |
|
|
Kerry Gordon has been in the health sector for over 40 years, mostly in the world of statistics and programming. As a past Chair of PSI, Kerry has sat on the PSI Board of Directors and has also served on the PSI Scientific, Website, Regulatory and Training subcommittees. After starting out with the NHS, he moved into the industry at (what is now) Novartis. Then, after a spell at the University of Kent, he worked for Quintiles (latterly IQVIA) for over 20 years and at Parexel for a few years. Kerry joined PHASTAR, a niche Biometrics CRO, in July last year as an Engagement Head, looking after specific customer accounts. |
Date: Wednesday 2nd & Thursday 3rd October 2024
Time: Day 1: 09:00-17:00 | Day 2: 09:00-16:00 BST
Location: This Course will be taught in-person, at Crowne Plaza London Heathrow T4 (Terminal 4, Swindon Road, Hounslow, TW6 3FJ, United Kingdom)
Speakers: Dan Evans (DMK2 Consulting Limited), Ines Antunes dos Reis (MHRA), Yolanda Barbachano (BioNTech) and Kerry Gordon (Phastar).
Who is this event intended for? Statisticians who would like to enhance their knowledge of the latest ICH and other global and regional regulatory guidelines.
What is the benefit of attending? Participants will either gain or expand upon their knowledge and awareness of the regulatory environment and associated guidelines.
Early Bird PSI Members = £370+VAT
PSI Members = £410+VAT
Early Bird Non-Members = £480+VAT
Non-Members = £520+VAT
*Please note: Non-Member rates include PSI membership until 31 Dec. 2025.
To book your place, please click here.
Please note:
- There are a limited number of places for this in-person event. Due to its popularity, we do kindly ask you to consider both the timings and location before committing to attend.
- Registration does not include hotel accommodation. If a hotel is required (as this Course runs over two consecutive days), delegates will need to book their own accommodation separately. As the Course is being held at the Crowne Plaza London Heathrow T4, we recommend booking your accommodation here. Additionally, there is a daily charge for parking, which can also be booked with the Reservations team. To make your booking, please contact the Crowne Plaza reservations team via the following:
Email: Reservations5@cpheathrowt4.com
Telephone: 0203 971 4182 or 0203 971 4181
The course will describe key ICH guidelines of main interest to statisticians, as well as guidance documents from regulatory bodies such as EMA, FDA, PMDA, MHRA and CDE. The focus of the course will be on the content of ICH E9 (Statistical Principles for Clinical Trials), ICH E9(R1) (Estimands and Sensitivity Analysis in Clinical Trials), ICH E10 (Choice of Control Group in Clinical Trials), ICH E6 (Good Clinical Practice), ICH E17 (Multi-Regional Clinical Trials), and ICH E20 (Adaptive Clinical Trials), but other key regulatory guidance documents will also be highlighted. The course will also include workshops, a Q&A session and guidance on how to seek advice from regulators.
|
Speaker |
Biography |
Dan Evans |
Dan Evans has worked for Pfizer for over 30 years in a variety of statistical and team leadership roles leading the global development of medicines across many therapeutic areas. He has a particular focus on statistical regulatory topics and has been an active member of the PSI/EFSPI Regulatory Special Interest Group for over 15 years, participating in the co-ordination of reviews of new regulatory guidelines and policies and engagement on statistical topics with regulatory statisticians. He’s currently working as an independent statistical consultant. |
|
|
Inês has been a statistical assessor at the Medicines and Healthcare products Regulatory Agency (MHRA) since 2018. Her work focuses on assessment of marketing authorisation applications, providing scientific advice to companies, assessment of clinical investigation applications, and participating in the development of regulatory guidelines. She has over 7 years of experience in the regulatory system, having previously worked for the European Medicines Agency (EMA). She supported the ICH E9(R1) expert working group on Estimands and Sensitivity Analysis in Clinical Trials and contributed to the E9(R1) training materials published in the ICH website. |
|
|
Yolanda has worked as a statistician for nearly two decades, her experience spans from academia to regulatory bodies and now industry. Her interest in regulatory guidance developed whilst working over 10 years as a statistical assessor at the MHRA, and as part of the EMA system. Yolanda now works at BioNTech where she has to consider regulatory requirements for other regions. She has a PhD in statistics and a BSc in mathematics, both from the University of Sussex. |
|
|
Kerry Gordon has been in the health sector for over 40 years, mostly in the world of statistics and programming. As a past Chair of PSI, Kerry has sat on the PSI Board of Directors and has also served on the PSI Scientific, Website, Regulatory and Training subcommittees. After starting out with the NHS, he moved into the industry at (what is now) Novartis. Then, after a spell at the University of Kent, he worked for Quintiles (latterly IQVIA) for over 20 years and at Parexel for a few years. Kerry joined PHASTAR, a niche Biometrics CRO, in July last year as an Engagement Head, looking after specific customer accounts. |
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.
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.
The Institute of Cancer Research are seeking to appoint a Research Group Leader to join The CRUK Clinical Trials and Statistics Unit at the ICR.
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.
The BioMarin internship programme will enable students to gain valuable experience and knowledge of the processes and systems within BioMarin, whilst gaining an insight into the pharmaceutical/biotech industry.
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. | |||
