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For more than a year, pharmaceutical laboratories, biotech companies and CROs have been facing a totally new context for the management of clinical trials in Europe. After the implementation of the CTIS (Clinical Trial Information System) and the consequent full entry into force of the EU Clinical Trial Regulation 536/2014, we must learn to work within a new scenario.

Raquel Reviejo and Lidya Domínguez will analyze these changes and their consequences on the operations of organizations dedicated to clinical research at the conference that will take place on May 3, 2023 at the Outsourcing Clinical Trials Europe 2023 congress, at 5:15 PM.

These are some of the topics to be discussed:

• Intro to EuCTR and CTIS
• Experience in CTIS and KPIs: Organization model Sponsor-CRO: Challenges and Success cases
• Benefits of submitting through the same portal for all sponsors/CROs and the advantages for pharmaceutical and biopharma companies of standardized timelines
• Overview of major new requirements, such as transparency rules and regulatory submission packages
• Understanding the new trial authorization process for regulatory and ethical approval

About Raquel Reviejo

Raquel Reviejo is an EU Regional Submission Lead at MSD with 13 years of experience in clinical research.

In her current position, Raquel is accountable for the overall management and coordination of the submission activities across EU countries for assigned Clinical Trials. She is also involved in the EU CTR Transition strategy project.

Raquel received a Bachelor of Pharmacy degree from the Universidad Complutense of Madrid and a master’s degree in monitoring and management of clinical trials (Colegio Oficial de Farmacéuticos de Madrid)

About Lidya Domínguez

Lidya Domínguez’s working years have always been related to clinical research. She graduated in nutrition and human dietic and master’s coursed in project management and several expert courses in Clinical Trials and Regulatory Procedures. She is the Head of the Clinical Research Department at Sermes CRO, an International Contract Research Organization with headquarters in Madrid, Spain. Oncology and cellular and advanced therapies are amongst her main therapeutic experience, but during her large experience in pharma, she has worked with several TAs, such as endocrinology, vaccines, infectious diseases, etc. She is an expert in European Clinical Trial Regulation. She has been involved in the CTIS project from the right beginning, as part of EMA’s 15-people working group since 2017 for the development of this new European clinical trials portal. She has been certified by the EMA as CTIS Master Trainer. Lidya’s team at Sermes CRO achieved the first submission of a clinical trial through CTIS in Spain, in March 2022. Since then, they have never stopped submitting and transitioning clinical trials via CTIS.

All the info about Outsourcing Clinical Trials Europe  2023 Congress here.