The European Medicines Agency (EMA) Innovation Task Force (ITF) has been instrumental in guiding the development of innovative medicines and ensuring they meet regulatory standards. Over the years, this free-of-charge initiative has provided invaluable support for novel therapies and breakthrough solutions. Here’s a snapshot of what the ITF procedure entails:
Pre-Submission Consultation: Engage early with EMA experts to refine your innovative ideas.
Customized Advice: Get strategic guidance on development and regulatory pathways.
Feedback and Insights: Receive tailored feedback to navigate potential challenges in development and regulatory requirements.
For developers eager to apply, here are the key activities you should focus on:
Strategic Planning: Develop a clear strategy for your application and drug development plan, understanding the regulatory framework and preparing a robust case.
Documentation Preparation: Ensure all necessary documentation including the ITF application form and briefing document are prepared and submitted via the appropriate EMA gateways in compliance with regulatory requirements.
Briefing Document Development: Prepare detailed briefing documents with specific questions related to non-clinical, clinical, or CMC aspects, establishing your company position clearly.
Presentation Preparation: Create a comprehensive presentation for the ITF meeting to effectively communicate your innovation and receive valuable feedback from the experts of the EMA and national competent authorities.
Meeting Minutes Preparation: Document the meeting discussions accurately to ensure all feedback and action points are captured for follow-up.
Starodub is committed to supporting you in maximizing the benefits of the ITF initiative. If you are considering an ITF meeting for your product, we invite you to reach out to us. Let’s discuss how we can support your journey and turn your innovative ideas into medicines with our expert guidance every step of the way!