Event

GMP for IMP (Online short course)

Add to:

Date: Wednesday 3rd July 2024
Time: 10:00-15:00 BST
Location: Online

Overview

This training will provide participants with an understanding of the legislation and guidance covering manufacture and handling of investigational medicinal products in the EU.
The main document we focus on is Annexe 13 of Eudralex Volume 4 which covers requirements for manufacture of medicinal products specifically for use in a clinical trial setting. We also consider key GMP changes coming with the new EU Clinical Trials Regulation and associated guidelines.
We also cover the EU Guideline on IMPs and Non-IMPs – soon to be updated to Auxiliary Medicinal Products.
We also include an interactive workshop session looking at Site Management of IMP: Personnel, Premises and Processes.

Who is it suitable for?

This course is suitable for anyone involved in manufacture and/or management of Investigational Medicinal Products in clinical trials, for example: Clinical Project Managers, CRAs, CTAs, Clinical Trial Pharmacists, Contract Manufacturers.

Objectives:

To provide delegates with an understanding of:

  • Legislation and guidance covering manufacture and handling of investigational medicinal products in the EU/UK
  • Recent and forthcoming changes in regulatory requirements
  • Practical implications for clinical trials

How to register

For more information and to register, please visit: https://www.ucl.ac.uk/clinical-trials-and-methodology/study/short-courses/gmp-imp

Upcoming Events

PSI Webinar: Surrogacy

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.

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 Career Young Virtual Event (Q2 2024)

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 EIWG Webinar: Estimands framework in action, the Alzheimer's disease case

The webinar will show how the estimand framework was applied in a Phase 3 trial in Alzheimer's disease.

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.

PSI Career Young Virtual Event (Q3 2024)

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.

Joint PSI/EFSPI Causal Inference SIG Webinar: Opportunities in applying a causal inference framework during the analysis of an RCT

This webinar will discuss opportunities in applying causal inference methodology during the analysis of RCT data.

PSI Career Young Virtual Event (Q4 2024)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

Latest Jobs

Apprentice Statistician

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.

Statistician, Data Science

We have exciting new opportunities available for Study Statisticians, Support Statisticians and Exploratory Statisticians at various levels.