Unlocking the EU Market: Cost-Effective Strategies for Regulatory&Clinical

From Awareness to Enrollment: Can Social Media Close the Gap in Patient Recruitment?

Date & Time: 26 November 2025 from 03:00 PM to 04:30 PM (CET)

•The meeting will start at 03.00PM o’clock.•Audio is available either through your computer or through phone connection (dial-in).•Your line will be kept on mute.•At the end, there will be time for questions and you can submit your questionsthrough the ‘question’ box.•After the webinar, connect to the EUCROF eLearnIN platform (https://eucrof.eu)to retrieve materials, customer satisfaction survey and certificate of attendance.•At the end of the webinar, a Forum Discussion will be opened on the eLearnIN platform (https://eucrof.eu) to ask further questions to the speaker or start an open discussion on the topic of the webinar.

Overview

An exclusive session on how to design efficient clinical trials through careful budget planning and regulatory guidance for optimal resource allocation, incorporating both strategic designs and tactical monitoring approaches.

🔍 You will learn how to:

✅  Engage with EMA early: Use ITF, Scientific Advice, and ODD for regulatory alignment and optimized trial design  

✅  Design efficient trials: Plan recruitment, endpoints, and budget management for cost-effective execution  

✅  Accelerate market access: Leverage PRIME, conditional approval, and Adaptive Pathways to reduce development timelines  

✅  Optimize resources: Utilize SME Office for fee reductions and regulatory support

✅ Align clinical & financial goals: Incorporate early regulatory feedback to ensure cost predictability and avoid mid-trial redesigns 

Presenters:

Dr. Philip Raeth is the Managing Director of Palleos, leveraging over a decade of expertise to drive innovation in the pharmaceutical industry. Since joining the company in 2011, he has held pivotal roles in Business Development, Finance, Data Management/IT, and has extensive experience in full-service clinical trials, specifically Investigator-Initiated Trials (IIT), as well as computerized software validation. Dr. Räth holds a Ph.D. in Business Administration with a specialization in Management Information Systems. His primary interest lies in developing digitally driven strategies to clinical trials as well as current developments in AI as well as their impact on the industry.

Polina Shatrova , Head of Budgets and Proposals, Palleos

With a strong foundation in both linguistics and corporate management, along with professional training in financial management, Polina Shatrova has developed a dynamic career in the clinical trial industry. Beginning as a clinical trial coordinator, Polina quickly transitioned into business development within her first year in the CRO sector. Over the years, Polina has excelled in various business development roles, leveraging her diverse skill set to drive growth and innovation in the business of service provision. For the past four years, she has served as the Director of Budgets and Proposals, utilizing her extensive experience to lead precise cost estimation of clinical trials and proposal development for pharma and biotech industry.

Valentyna Starodub, CEO, Starodub B.V., Valentyna has long experience in the pharmaceutical industry. In her previous jobs both in the Netherlands and Ireland, with world-wide leading pharmaceutical companies, she led teams of Regulatory professionals. She holds a Ph.D. in biotechnology and has a broad experience in regulatory CMC. Her specialty is strategic decision making for large projects.

Registration deadline: 25 November 2025 at 6 p.m.

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