Brief:
As Europe bids farewell to EudraCT after nearly two decades, it welcomes the Clinical Trial Information System (CTIS) as the new standard. CTIS has been operational since January 2022, and serves as the unified platform for submitting, assessing, authorizing, supervising, and reporting clinical trials across EU Member States. During the transition period until January 31, 2023, sponsors had the flexibility to choose between CTIS and EudraCT for documentation submission. However, since January 31, 2023, all new Clinical Trial Applications must be made through CTIS. By January 31, 2025, all ongoing trials must migrate to CTIS, signifying a pivotal shift in trial management.
Novotech stands ready to support sponsors throughout this transition by offering this informative webinar led by CTIS experts. The team will be available via a live interactive chat box to address your queries.
Speakers:
Diana Filipescu, MSc.
Business Development Manager, Novotech
With 12 years of experience in the clinical trials and regulatory landscape, Diana brings a dual perspective to the healthcare industry. She has a Bachelor in Business Management, a Bachelor of Laws and a Master's in Health Management. Leveraging this diverse educational foundation, Diana began her career in Regulatory Affairs, gaining an in-depth understanding of compliance within the healthcare sector.
Inspired by a passion for innovation and driving positive change, Diana transitioned to Business Development, and now focuses on identifying and establishing strategic partnerships that contribute to advancements in the healthcare industry.
Yoshiko Stowell, PhD.
Head of Regulatory Affairs, Neuron 23
Yoshiko Stowell, PhD, PMP is a Head of Regulatory Affairs at Neuron 23. She has over 19 years of diverse experience in Regulatory Affairs (Clinical and CMC), R&D, and Project Management. She has diverse experience from early development to global Phase III clinical studies and NDA/MAA for the treatment of CNS disorders, pain management, and rare diseases. Yoshiko is a RAPS San Francisco Bay Area Chapter Chair. Yoshiko holds a BS in Chemistry from Tokyo University of Science, MS in Chemical Engineering from University of Oklahoma, and PhD in Pharmaceutical Science from University of the Pacific.
Kathryn Paunicka, Dr.
Associate Director, Arcus Biosciences
Dr. Paunicka has been in regulatory since 2016 where she started her career at Genentech in supporting global BLA filings and establishing regulatory strategy in oncology indications. She proceeded her work at Santen Inc where she worked on regulatory strategy for Orphan Drug and Pediatric indications and NDA filings.
She is currently an associate director at Arcus Biosciences where her role is to oversee and establish overall regulatory strategy on late stage development global clinical trials in oncology. She had a Bachelor's Degree in Biochemistry from Purdue University, a Ph.D in Immunology at University of Texas Southwestern Medical, and worked in Neuro-Immunology as a post-doctoral fellow at Stanford University.