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
About Our Expert
Mette Due Theilade Thomsen, Ph.D., is RareMoon's exclusive PIP expert since 2018, bringing over two decades of experience in regulatory strategies. She has previously worked at the Danish Medicines Agency and the EMA, providing her with deep insights into European pediatric regulatory requirements.
Her specialization in regulatory strategies for PIPs has made her a sought-after expert in the field, and her continued collaboration with the EMA ensures that participants receive the most current and practical guidance available.