Webinar: Effective IMPD Writing. The Quality Part
Effective IMPD writing, including the quality part is a vital document that contains information about an investigational medicinal product and it is an essential part of the Clinical Trial Application (CTA), which is required by competent authorities in EU.
The purpose of this webinar is to share the best practices in the preparation of IMPD in order to meet the expectations of competent authorities and to learn why effective CMC technical writing is crucial for the development of a high quality IMPD.
You will learn about:
1. Regulatory guidelines for the Investigational Medicinal Product Dossier
2. IMPD structure and content
3. Best practices for the preparation of IMPD
- Best practices in IMPD Quality writing;
- Writing style to produce accurate, concise, and clear technical text.
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Who should attend? Professionals from the following fields:
- Regulatory
- R&D
- QA/QC
- Compliance
- Product Development
- Manufacturing
Duration: 40 min.
Speakers:
- Head of the Central Functions for Regulatory Affairs, Ramunė Rūkienė;
- Medical Writer, Eglė Deimantavičiūtė.
Ramunė Rūkienė, MSc
Head of Regulatory Affairs Central Operations
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This time we will focus on technical writing and preparation for it. Also, I will provide some primary recommendations for CMC writers. The IND/IMPD being a regulatory document, has the same structure as CTD dossier. However, it includes remarkably less information on the developmental product, yet, the technical writers should understand that they will need to prepare the document in the way to reflect the actual production process and control further during the development in the later clinical phases.
