The course objective is to inform statisticians about the likely interactions they might have with regulatory agencies, both during a submission and at other times during drug development, and give advice on how to make these interactions most effective. The course will focus on clinical development.
The course is primarily targeted at project statisticians who interact with regulators, but would also be suitable for those who may move into this role in the near future.
The course will be presented by experienced statisticians from the MHRA, FDA and those with expansive pharmaceutical company employment and representatives from a company regulatory affairs department. The course will consist of lectures, practical examples and discussions. There will not be any computer exercises.
Course runs from:
Day 1: 10:00 – 17:00 (registration from 9:30)
Day 2: 09:00 – 16:00
Key Topics:
• Introduction to the regulatory agencies
• Interactions between EU and US regulators and statisticians at each stage of development
• Overview of regulatory practices in other regions
Registration:
Registration on or before 15th August:
PSI Member
£595 + VAT
Non-Member
£690 + VAT
Registration after 15th August:
PSI Member
£695 + VAT
Non-Member
£790 + VAT
Registration has now closed.
Registration costs include lunch and refreshments. PSI are holding a limited number of hotel rooms on 25th and 26th September which will be allocated on a first come first served basis. Please contact psi@mci-group.com to reserve a room.
The course objective is to inform statisticians about the likely interactions they might have with regulatory agencies, both during a submission and at other times during drug development, and give advice on how to make these interactions most effective. The course will focus on clinical development.
The course is primarily targeted at project statisticians who interact with regulators, but would also be suitable for those who may move into this role in the near future.
The course will be presented by experienced statisticians from the MHRA, FDA and those with expansive pharmaceutical company employment and representatives from a company regulatory affairs department. The course will consist of lectures, practical examples and discussions. There will not be any computer exercises.
Course runs from:
Day 1: 10:00 – 17:00 (registration from 9:30)
Day 2: 09:00 – 16:00
Key Topics:
• Introduction to the regulatory agencies
• Interactions between EU and US regulators and statisticians at each stage of development
• Overview of regulatory practices in other regions
Registration:
Registration on or before 15th August:
PSI Member
£595 + VAT
Non-Member
£690 + VAT
Registration after 15th August:
PSI Member
£695 + VAT
Non-Member
£790 + VAT
Registration has now closed.
Registration costs include lunch and refreshments. PSI are holding a limited number of hotel rooms on 25th and 26th September which will be allocated on a first come first served basis. Please contact psi@mci-group.com to reserve a room.
The course objective is to inform statisticians about the likely interactions they might have with regulatory agencies, both during a submission and at other times during drug development, and give advice on how to make these interactions most effective. The course will focus on clinical development.
The course is primarily targeted at project statisticians who interact with regulators, but would also be suitable for those who may move into this role in the near future.
The course will be presented by experienced statisticians from the MHRA, FDA and those with expansive pharmaceutical company employment and representatives from a company regulatory affairs department. The course will consist of lectures, practical examples and discussions. There will not be any computer exercises.
Course runs from:
Day 1: 10:00 – 17:00 (registration from 9:30)
Day 2: 09:00 – 16:00
Key Topics:
• Introduction to the regulatory agencies
• Interactions between EU and US regulators and statisticians at each stage of development
• Overview of regulatory practices in other regions
Registration:
Registration on or before 15th August:
PSI Member
£595 + VAT
Non-Member
£690 + VAT
Registration after 15th August:
PSI Member
£695 + VAT
Non-Member
£790 + VAT
Registration has now closed.
Registration costs include lunch and refreshments. PSI are holding a limited number of hotel rooms on 25th and 26th September which will be allocated on a first come first served basis. Please contact psi@mci-group.com to reserve a room.
The course objective is to inform statisticians about the likely interactions they might have with regulatory agencies, both during a submission and at other times during drug development, and give advice on how to make these interactions most effective. The course will focus on clinical development.
The course is primarily targeted at project statisticians who interact with regulators, but would also be suitable for those who may move into this role in the near future.
The course will be presented by experienced statisticians from the MHRA, FDA and those with expansive pharmaceutical company employment and representatives from a company regulatory affairs department. The course will consist of lectures, practical examples and discussions. There will not be any computer exercises.
Course runs from:
Day 1: 10:00 – 17:00 (registration from 9:30)
Day 2: 09:00 – 16:00
Key Topics:
• Introduction to the regulatory agencies
• Interactions between EU and US regulators and statisticians at each stage of development
• Overview of regulatory practices in other regions
Registration:
Registration on or before 15th August:
PSI Member
£595 + VAT
Non-Member
£690 + VAT
Registration after 15th August:
PSI Member
£695 + VAT
Non-Member
£790 + VAT
Registration has now closed.
Registration costs include lunch and refreshments. PSI are holding a limited number of hotel rooms on 25th and 26th September which will be allocated on a first come first served basis. Please contact psi@mci-group.com to reserve a room.
The course objective is to inform statisticians about the likely interactions they might have with regulatory agencies, both during a submission and at other times during drug development, and give advice on how to make these interactions most effective. The course will focus on clinical development.
The course is primarily targeted at project statisticians who interact with regulators, but would also be suitable for those who may move into this role in the near future.
The course will be presented by experienced statisticians from the MHRA, FDA and those with expansive pharmaceutical company employment and representatives from a company regulatory affairs department. The course will consist of lectures, practical examples and discussions. There will not be any computer exercises.
Course runs from:
Day 1: 10:00 – 17:00 (registration from 9:30)
Day 2: 09:00 – 16:00
Key Topics:
• Introduction to the regulatory agencies
• Interactions between EU and US regulators and statisticians at each stage of development
• Overview of regulatory practices in other regions
Registration:
Registration on or before 15th August:
PSI Member
£595 + VAT
Non-Member
£690 + VAT
Registration after 15th August:
PSI Member
£695 + VAT
Non-Member
£790 + VAT
Registration has now closed.
Registration costs include lunch and refreshments. PSI are holding a limited number of hotel rooms on 25th and 26th September which will be allocated on a first come first served basis. Please contact psi@mci-group.com to reserve a room.
The course objective is to inform statisticians about the likely interactions they might have with regulatory agencies, both during a submission and at other times during drug development, and give advice on how to make these interactions most effective. The course will focus on clinical development.
The course is primarily targeted at project statisticians who interact with regulators, but would also be suitable for those who may move into this role in the near future.
The course will be presented by experienced statisticians from the MHRA, FDA and those with expansive pharmaceutical company employment and representatives from a company regulatory affairs department. The course will consist of lectures, practical examples and discussions. There will not be any computer exercises.
Course runs from:
Day 1: 10:00 – 17:00 (registration from 9:30)
Day 2: 09:00 – 16:00
Key Topics:
• Introduction to the regulatory agencies
• Interactions between EU and US regulators and statisticians at each stage of development
• Overview of regulatory practices in other regions
Registration:
Registration on or before 15th August:
PSI Member
£595 + VAT
Non-Member
£690 + VAT
Registration after 15th August:
PSI Member
£695 + VAT
Non-Member
£790 + VAT
Registration has now closed.
Registration costs include lunch and refreshments. PSI are holding a limited number of hotel rooms on 25th and 26th September which will be allocated on a first come first served basis. Please contact psi@mci-group.com to reserve a room.
Upcoming Events
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.
The event will open with an overview on drug development in women’s health from a clinician perspective. This talk is followed by talks about statistical challenges when planning IVF studies and analysing the menstrual cycles.
This webinar will provide an overview of surrogacy for licensing and reimbursement. In turn, the need of extensions of the SPIRIT and CONSORT statement will be defined and outlined, with case studies to support.
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.
Joint PSI/EFSPI Data Science SIG Webinar: Developing Digital Measures (Digital Biomarkers) in Drug Development – insights from Mobilise D consortium
We will share a brief overview of what Mobilise D is and why it is an important step stone in the development of digital biomarkers, and how Mobilise D outputs can be relevant for you.
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 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.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
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