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The Investigational Medicinal Product Dossier: Gateway to Introducing New Drugs in the European Union

Level:
Advanced
Area:
Drug Development
Code:
DDA28
Duration:
03:30:00
Workshop profile:
The Investigational Medicinal Product Dossier (IMPD) is an important part of the clinical trial application (CTA) which is submitted to the EMA for approval of clinical trials of investigational medicinal products (IMPs) in the EU. Those who stand to benefit from this workshop are regulatory personnel and medical writers in the pharmaceutical industry, CROs, and medical writing agencies who are involved in preparing regulatory documentation – especially documents pertaining to the chemistry, manufacturing, and quality control (CMC) of IMPs. Participants of this workshop will be expected to have experience/knowledge of the drug development and approval process, especially in the US and the EU as well as familiarity with various components of the eCTD.
Objective:
Participants of this workshop will get an overview on the individual parts of the IMPD, as well as details of the relevant source documents and submission requirements and the medical writer’s role in the preparation of the dossier.
Content:
The IMPD includes summaries of information related to the quality, manufacture and control of the IMP, data from non-clinical studies and from its clinical use. An overall risk-benefit assessment, critical analyses of the non-clinical and clinical data in relation to the potential risks and benefits of the proposed study also have to be part of the IMPD. The main focus of the workshop will be to clarify the medical writer’s role in the selection, assembly, and summary of relevant source documents for drafting a full or simplified IMPD for medicinal drug products, with a strong emphasis on the chemistry, manufacturing, and quality control (CMC) components of these. The workshop is planned to be interactive and will include discussion of participants’ questions submitted in their pre-workshop assignments, where relevant. There will also be a handful of exercises carried out during the workshop to encourage overall participation.