From Confusion to Confidence: Mastering EU CTR/CTIS Webinar

The EU Clinical Trials Regulation (CTR 536/2014) and CTIS have reshaped the regulatory landscape—yet sponsors still face delays, RFIs, and country-specific hurdles.

Register here: https://cromoswebinar.com/

Join Cromos Pharma’s regulatory leaders for a free 50-minute live webinar packed with practical tools, real case studies, and live Q&A. You’ll walk away knowing how to:

Why You Should Attend

Struggling with CTIS submissions? You’re not alone.
This webinar cuts through the complexity and gives you a clear roadmap — backed by real experience and practical tools.

• Plan and manage multi-country submissions with confidence
• Avoid RFIs and submission delays
• Understand what’s truly harmonized under CTR — and what’s not
• Get Legal Rep and QP documentation right the first time
• Handle country-specific quirks in Hungary, Romania, Bulgaria, and Spain

No theory. Just proven strategies that work in the real world.

Meet Your Experts

Dr. Vlad Bogin – CEO, Cromos Pharma
Opening strategy and why sponsors can’t afford to get CTR wrong

Marina Romanova, DPT – Head of Regulatory Affairs
CTIS platform, user roles, and multi-country submission setup

Olga Kodatska – Senior Regulatory Affairs Manager
RFI process breakdown — what triggers them and how to avoid them

Monika David – EU Regulatory Lead
Legal Representative and QP obligations made simple

Agenda

1. Welcome & Webinar Goals – Vlad Bogin
2. CTIS Walkthrough – Interface, roles, structure – Marina
3. RFI Process – Phases, timing, common mistakes – Olga
4. Country-Level Pitfalls – Specifics from key EU markets – Olga
5. Legal Rep & QP Documentation – Risks and responsibilities – Monika
6. Live Q&A – Bring your questions

Exclusive Offer for Attendees

All attendees will be eligible for a free 1:1 consultation with Cromos Pharma’s regulatory team after the webinar.
Ask about your specific trial, submission plan, or country strategy — no strings attached.

Who Should Join

This session is designed for:

• Clinical operations managers
• Regulatory affairs professionals
• Strategic outsourcing leads
• Sponsors planning EU trials
• CROs handling multi-country submissions

If you’re working on a submission under CTR — you need this webinar.

Backed by 21 years of global expertise and dozens of successful CTIS filings, Cromos Pharma brings you proven strategies you can apply immediately.

Ready to get the latest insights on working with CTR/CTIS?

Date: September 23, 2025
Time: 5:00 PM CET / 11:00 AM EDT
Format: Zoom | 50 minutes + Q&A
Cost: Free

Register here: https://cromoswebinar.com/