The model-based approach to various aspects of drug development is rapidly being adopted by many of the leading pharmaceutical companies and has been identified by the FDA as a valuable tool to improve efficiency in drug development. These workshops focus on the optimal use of compound-specific in vitro and in vivo data, together with system-specific information, to simulate and understand drug behaviour in various target populations. This integrated approach informs decisions related to Investigational New Drug (IND) and New Drug Applications (NDA) and assists with the conduct and optimal design of clinical studies. The ultimate aim is to improve the quality of submissions for regulatory approval.
Our workshops are relevant to senior level managers as well as scientists working in the fields of drug metabolism, ADME, clinical pharmacology, pharmacokinetics, PBPK and PK/ PD, both in industry or in academia and research institutes. There is a focus on facilitating communication and interaction between pre-clinical in vitrogroups and those responsible for the conduct of early clinical studies. The courses provide a solid grounding in model-based approaches and are not aimed solely at individuals who have hands-on experience.
Participants will learn about the application of ‘prior knowledge’ to improve the selection and design of clinical studies. The workshops are designed to provide the necessary understanding and skills to simulate and predict the pharmacokinetics of drugs in any relevant populations and assess pharmacodynamic effects at an early stage.
The course is comprised of lectures – delivered by leading experts in each field of PK and PD – interspersed with interactive workshops and demos centred on practical examples of model-based approaches. Delegates work in small groups with an expert tutor. Non-Simcyp users are guided through the course whereas more experienced users benefit from exploring the science and specific algorithms in more depth through discussions with tutors and peers.
You do not need to be from an institute which is a member of the Simcyp Consortium to benefit from our workshops. Each event attracts a range of participants from industry, academia and the regulatory bodies who may or may not be associated with the Consortium.
Each year Consortium Members are allocated a number of free workshop places (based on the number and type of licenses held). If you are unsure of the membership status of your organisation, or you wish to check your entitlement to, or book, a free place (member organisations only), please contact us. Once your place has been allocated, please submit a registration form ensuring that you have filled in the name of organisation, site and department and ticked the relevant boxes for free places.
The course and associated workshops provide an in-depth evaluation of the scientific background to various aspects of model-based drug development allowing attendees to grasp the fundamental concepts and become familiar with real world applications of these techniques. This differs from ‘On-Site Education’ which focuses solely on the day-to-day practicalities of navigating and using the Simcyp platform without delving into the underlying science. The programmes can be complementary if attendees wish to become expert users of Simcyp platform but otherwise they are independent.
Online booking for Simcyp events is now handled through the Simcyp Members’ Area. Your saved profile is automatically captured on the booking form so there is no need to re-enter your contact details. Click here to link to the booking forms – you will be prompted for your Simcyp Members’ Area user name (email address) and password. If you have forgotten your log-in credentials please follow the instructions on-screen.
If you have not yet registered for the Members’ Area please sign up now.
For further information please contact us.
Please note: The Simcyp workshops are week-long events which are split into two parts. Part I typically starts at 8.30am on Monday and ends at lunchtime on Wednesday. Part II of the workshop runs from Wednesday afternoon until lunchtime on Friday. Although there are breaks, the programme is fairly intensive.
Laptops and course materials will be provided.