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.
Starting Clinical Trials?
Make use of our expertise to smoothly prepare for clinical studies. Explore your options in a chat with one of our experts.
Who should attend? Professionals from the following fields:
- Product Development
Duration: 40 min.
- Head of the Central Functions for Regulatory Affairs, Ramunė Rūkienė;
- Medical Writer, Eglė Deimantavičiūtė.
Ramunė Rūkienė, MSc
Head of Regulatory Affairs Central Operations
Other content that might interest you:
Recently, we had the chance to reflect on our last 10 years of operations and were astonished by the unprecedented growth facts: The Clinical Research department grew 8 times the size it was back in 2013. Regulatory Affairs services became available to 32 new...
The role of Contract Research Organizations (CROs) in supporting mergers and acquisitions (M&As) is not a new concept, as CROs have been providing services in this area for several years. However, the demand for these services may have increased in recent years...
Regulatory Intelligence is a reliable and invaluable tool when it comes to pharmacovigilance. It's so important because it allows companies to remain up-to-date with the most recent drug safety data and identify new information quickly. What Is Regulatory...