We are excited to announce that one of RareMoon’s leading experts in Paediatric Investigation Plans (PIPs), Mette Due Theilade Thomsen, will host a Paediatric Investigation Plans Training session with DIA Global this November along with Dr. Roberto de Lisa. Dr. de Lisa is a Clinical Pharmacologist and Scientific Officer at the European Medicines Agency (EMA), specifically working in the Paediatric Medicines Office.
Mette originally developed this training course in collaboration with the EMA and first delivered it in 2012. Since then, she has continued to lead the course annually. Developed in collaboration with the EMA, this course is continually updated to reflect the latest regulatory developments. For the first time this year, this course is offered virtually, allowing participants worldwide to join.
About the Course
This comprehensive training is designed to provide participants with the knowledge and skills to navigate the regulatory landscape of pediatric drug development in Europe.
The training will cover the practical aspects of preparing and submitting PIPs, with detailed discussions of the latest updates from the EMA’s regulatory requirements. This is an excellent opportunity for pharmaceutical professionals involved in regulatory affairs, clinical development, and pediatric research to gain practical insights into submitting and approving pediatric drug plans. Participants will also have the chance to engage in Q&A sessions, providing an interactive platform for learning and professional growth.
Key Takeaways
- Gain a thorough understanding of the PIP regulatory pathway.
- Learn how to design and implement pediatric studies in alignment with EMA requirements.
- Explore real-world case studies of successful PIP approvals.
- Network with industry professionals and regulatory experts.
For those looking to stay ahead in pediatric drug development, this training offers an invaluable opportunity to enhance your knowledge and skill set.
Event Highlights
Date: November 4-7, 2024 (in four half-day sessions)
Location: Virtual
Host: DIA Global
Trainers:
Dr. Mette Due Theilade Thomsen
RareMoon PIP Specialist
Dr. Roberto de Lisa
Senior Scientific Specialist
Paediatric Medicines Office at the EMA
Scientific Evidence Generation Department
Don’t miss out on this chance to learn from RareMoon’s top expert and further your expertise in pediatric drug development.
EVent AgendaREgisterAbout Mette Due Theilade Thomsen
Mette Due Theilade Thomsen, PhD, specializes in regulatory strategies for Paediatric Investigation Plans (PIPs) and Paediatric Study Plans (PSPs) and has been RareMoon’s exclusive PIP expert since 2018. With over two decades of experience, she has held roles at the Danish Medicines Agency and the European Medicines Agency (EMA), where she managed PIP procedures and collaborated with the Paediatric Committee (PDCO). Mette is a leading expert in pediatric drug development, offering guidance to pharmaceutical companies on regulatory pathways and compliance with EU and US pediatric regulations.
About RareMoon
RareMoon is the leading consultancy firm in rare disease drug development, with deep expertise in regulatory strategy, clinical trial design, and Paediatric Investigation Plans (PIPs) submissions. We specialize in supporting biotech and pharmaceutical companies in navigating complex regulatory environments and accelerating the development of groundbreaking therapies. Our team of experts has decades of experience in rare diseases and works closely with clients to deliver strategic solutions that meet regulatory requirements while advancing innovative treatments for unmet medical needs.
Visit our website for more information about RareMoon.