Effective IMPD Writing. The Quality Part

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.

 

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, MSc, and Medical Writer, Eglė Deimantavičiūtė, MSc, who will share their experience on preparing Quality (CMC) part of the Investigational Medicinal Product Dossier (IMPD) and their advice on effective CMC technical writing.

Ramunė Rūkienė, MSc

Ramunė Rūkienė, MSc

Head of Regulatory Affairs Central Operations

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