Mastering CTIS

Strategies for Multi-Country Submissions, Compliance & Operational Success

Free Live Webinar
September 23, 2025 | 5:00 PM CET / 11:00 AM EDT

Register now on the Webinar

Mastering CTIS

Strategies for Multi-Country Submissions, Compliance & Operational Success

Free Live Webinar
September 23, 2025 | 5:00 PM CET / 11:00 AM EDT

Register now on the Webinar

About Cromos Pharma

Cromos Pharma is a US-based, ISO-accredited international contract research organization (CRO) with over 21 years of experience. We deliver integrated clinical research solutions designed to accelerate drug development and maximize success for our partners.

Organized by Cromos Pharma, this webinar brings together leading regulatory experts to help you confidently navigate CTIS and the EU Clinical Trials Regulation (CTR 536/2014).

Why You Should Attend?

CTIS submissions don’t have to be overwhelming.
If you’re struggling, you’re not alone — and there is a way forward.

This webinar will cut through the complexity, giving you a clear, practical roadmap supported by real-world experience, proven strategies, and actionable tools you can apply immediately.

Date

23 Sep | Tuesday | 2025

Time

5:00 PM CET / 11:00 AM EDT

Format

50 minutes + Q&A

Free

Free Live Webinar

In just 50 minutes, you'll learn how to:

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

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

Meet Your Experts

Dr. Vlad Bogin
FACP, MD

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
Monika David

EU Regulatory Lead

Legal Representative and QP obligations made simple
Olga Kodatska

Senior Regulatory Affairs Manager

RFI process breakdown — what triggers them and how to avoid them

Agenda

Vlad Bogin

Welcome & Webinar Goals

Marina Romanova

CTIS Walkthrough – Interface, roles, structure

Olga Kodatska

RFI Process – Phases, timing, common mistakes

Olga Kodatska

Country-Level Pitfalls – Specifics from key EU markets

Monika David

Legal Rep & QP Documentation – Risks and responsibilities

Live Q&A

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

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.

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

if you have any questions, feel free to contact us inquiry@cromospharma.com

© Cromos Pharma 2004-2025
Clinical trials in the US, Central, Eastern Europe, Central and Southwestern Asia
(Bulgaria, Croatia, Czech Rep., Estonia, Georgia, Hungary, Kazakhstan, Latvia, Lithuania, Moldova, Poland, Portugal, Romania, Russia, Serbia, Slovak Rep., Slovenia, Türkiye, Ukraine)