This webinar will take attendees through the lessons learned and timelines to EU CTR approval based on experiences so far.
The new EU Clinical Trials Regulation (CTR) aims to create a more favourable environment for research in Europe, as well as maintain the highest level of standards for patient safety, and increased transparency of clinical trial information. With any new regulatory review process there can be a period of adjustment as sponsors become accustomed to the new procedures and timelines.
During this webinar the featured speakers will outline the EU CTR process, sharing their experience of early phase clinical trial submissions so far. The webinar will offer insights into where efficiencies can be gained, pitfalls to avoid and how one can work together with their CRO to leverage the EU CTR as an opportunity to improve processes, whilst complying with legal responsibilities.
Register for this webinar on the EU CTR process to gain valuable insights on how to avoid pitfalls in the early phase clinical trial submissions and navigate the regulatory review process efficiently.
Vicki Lassonidou, Director, Regulatory Affairs, ICON
Vicki Lassonidou is an experienced regulatory professional with over 20 years in the pharmaceutical industry/clinical research organizations. She has experience in managing clinical trials with a strong focus on building and maintaining relationships at both company and industry level from an operational role within the organization. Since July 2020 Vicki has been part of the European Medicines Agency (EMA) sponsor stakeholders for the Clinical Trial Information System (CTIS) and supported with the development of functionalities and testing. As one of ICON’s EU CTR subject-matter experts she co-led implementation of the EU CTR in ICON.
Dr. Emma Meijer, Director, Project Management, ICON
Emma Meijer is an experienced clinical research management professional with over 15 years of experience in the management of regulatory submissions for clinical research. She oversees the project management of regulatory submissions under EU CTR at ICON, supporting sponsors to make the process as smooth and efficient as possible.
Who Should Attend?
Pharma/biotech/medical device companies looking to place clinical pharmacology trials with ICON at EU sites.
What You Will Learn
Attendees will get an in-depth look at:
- The new EU CTR regulatory review process in Europe — identifying the key differences and implications for an early phase study
- The efficiencies achieved within the EU CTR and Netherlands regulatory framework, streamlining early phase trial approval under both sponsor and CRO submission models
- Examples of both full regulatory support and hybrid models used to complete submissions in the Clinical Trials Information System (CTIS) under the EU CTR
- Submission lessons learned and timeline to approval data based on the featured speakers’ experience
ICON is the world’s leading clinical research organisation, powered by healthcare intelligence. From molecule to medicine, we advance clinical research providing a comprehensive suite of outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. Our outsourcing models can be adapted to suit small local trials to large global programs, including full service, standalone services, FSP and full asset development.
With headquarters in Dublin, Ireland, ICON employs approximately 41,150 employees in 113 locations in 53 countries.
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