TRANSPERFECT LIFE SCIENCES EU CTR EDUCATION HUB
Learn more about the EU CTR and how it is expected to impact life sciences organizations with insights from subject matter expert, Pierre-Frédéric Omnes.
MEET PIERRE
Pierre-Frédéric Omnes, Executive Director at TransPerfect Life Sciences, has over 20 years of experience in global CROs and pharma companies as a regulatory affairs consultant overseeing numerous multinational clinical trial applications globally. Pierre is a subject-matter expert on site startup and regulatory operations in global clinical trials as well as on the EU Clinical Trial Regulation 536/2014 (EU CTR) for corporate readiness, implementation and Clinical Trial Information System.
Pierre is part of the EMA-led initiative developing the EU Clinical Trial Information System (CTIS) as Lead Product Owner representing the Industry & Academia since 2019, continuing an engagement of several years in user acceptance testings, workshops and analysis & design sessions related to CTIS development and optimization.
How does TransPerfect’s EU CTR Solution support pharma companies?
What is the EU CTR?
Who will be impacted by the EU CTR?
What are the key challenges associated with EU CTR?
What are the key requirements of EU CTR that pharma companies should be aware of?
What is expected to change under EU CTR?
How can TransPerfect help mitigate rising costs under EU CTR?
WEBINAR
Navigating the EU Clinical Trial Regulation Complexities: Current Challenges and Opportunities
As the most significant change in the European Union clinical trial legislative ecosystem in 20 years, the European Union Clinical Trial Regulation 536/2014 (EU CTR) went live on January 31, 2022. For optimal EU CTR readiness, our webinar covers:
- Assessing EU CTR’s impact on the organization and planning readiness strategies based on the development portfolio (ongoing and planned)
- Managing submission activities using the new EU Portal, Clinical Trial Information System (CTIS), while accounting for evolving transparency rules
- Optimizing translation management for expedited handling of ethics/regulatory queries (up to 12 calendar days turnaround time)
- Piloting studies under EU CTR to confirm/adjust implementation strategies as needed
- Developing/evolving transparency strategies regarding the disclosure principles applied with EU CTR including authoring, redacting and deferring setup for study documents submitted or to be generated at the end of the trial
- Updating standard operating procedures (SOPs) and work instructions for those matters affected globally by this regional regulation, including the impact on external vendors contracted for clinical-trial-related activities
- Training teams to evolve their operational practices (clinical, medical, regulatory, transparency, etc.) to the new EU regulatory framework
FEATURED SPEAKERS
Watch the Webinar
Get in Touch
Discover how TransPerfect Life Sciences’ team of experts can support you in preparing for the upcoming EU CTR. Reach out today to chat with our regulatory consultant, Pierre-Frédéric Omnes.
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