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:
- Product Development
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
Head of Regulatory Affairs Central Operations
Starting Clinical Trials for your product?
Make use of our expertise to smoothly prepare for clinical studies. Explore your options in an informal chat with one of our experts.
Other content that might interest you:
Practical tips on Affiliate Based Outsourcing including for Regulatory Affairsoptimization of local RA setup, management and relevant costs.
Company registration is part of the common regulatory requirements in several Middle Eastern and North African (MENA) countries. Nevertheless, it can be easily overlooked in preparation for drug filing and the overall regulatory picture. MENA countries are accepting...
Regulatory affairs for biosimilars in Middle East North Africa (MENA) region are evolving as existing guidelines and regulatory frameworks are being updated. Since European Medicines Agency (EMA) introduced a legal pathway for biosimilars approval in 2004, several...