22 February - 15:00 -16:00 GMT / 16:00 – 17:00 CET

Not just another CTR webinar: What do you really need to know?

Don't miss this opportunity to gain a comprehensive understanding of the new EU Clinical Trial Regulation and its implications for the pharmaceutical and biotech industry. With a focus on key changes, impacts on clinical trials, case studies, and future trends, this session aims to equip pharmaceutical and biotech industry stakeholders with essential knowledge and pragmatic guidance for navigating the evolving regulatory landscape.

Learning outcomes 
• Understanding the key changes and updates introduced in the new EU Clinical Trial Regulation.
• Insights into the impact of the regulation on trial design and overall drug development strategy
• Strategies for ensuring compliance and best practices in navigating regulatory challenges.
• Pragmatic guidance on adapting existing protocols to align with the new regulatory framework.
• Keeping track of the evolving transparency rules of the EU Clinical Trial Regulation.
• Q&A sessions for participants to address specific concerns and receive expert clarification.

Target Audience
Pharmaceutical and Biotech Industry stakeholders, from small to large size companies, with offices mainly based in Europe, the US, Japan, Australia, New Zealand, LATAM and Canada.

Speaker details

Wafa Bouaziz, Managing Director & Head of Regulatory Affairs, Orphix Consulting GmbH, DLRC Group

Wafa is a global regulatory professional with a broad experience across various therapeutic areas including rheumatology, anti-infective, dermatology and oncology. With her strong scientific, regulatory, and managerial expertise she successfully led both early development projects (CTA and IND submissions) and full development programs (MAA and NDA/BLA). She has supported clients with several investigational products through their European regulatory journey, advising on CTA requirements from a strategic perspective. She also acts as the EU legal representative under CTR and helps companies ensuring compliance with the new regulation. 

James Biddlecombe, Business Transformation and CTR Lead, DLRC Ltd, DLRC Group

James’s journey with the EU CTR started in 2017 working at the EMA in the CTIS business team. Over the last 6 years he supported the development of the regulation and guidance, the development of CTIS, and has supported clients with CTR readiness and CTA submissions. He has supported numerous clients in getting them ready for the CTR Go-Live through training, redesign of operating models, and updates to process and procedures. More recently, he supports clients with strategic direction for trials submitted under the CTR and helps to navigate EU CTR guidelines and ensure CTA document compliance with the regulation.

Disclaimer: Whilst TOPRA is running this webinar for DLRC, this is not an endorsement of DLRC, DLRC's affiliates, employees or its products and services. TOPRA is also not responsible for the content or views expressed during the webinar.

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Pricing

• Members: free
• Non-members: free

Terms and Conditions

By purchasing this webinar, you are agreeing to TOPRA's training terms and conditions.