Clinical Trials Regulation: What do you really need to know?

Webinar

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

Do you want to gain a comprehensive understanding of the new EU Clinical Trial Regulation and its implications for the pharmaceutical and biotech industry? Our recent webinar provides precisely that.

With a laser focus on pivotal changes, impacts on clinical trials, real-world 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.

Meet Our Experts

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 six 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 processes 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.

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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.

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Are you prepared for the new Clinical Trials Regulation?

The EU Clinical Trials Regulation (CTR) entered into force on 31 January 2022 and became mandatory for all new applications from 31 January 2023.

Speak to us today to make sure you are ready for the new regulation.

Contact our experts

Other Resources

Whitepaper

Patent Filing Considerations in View of Revised Clinical Trial Regulation Transparency Rules

The transparency requirements of the Clinical Trials Regulation present a complex intellectual property challenge requiring a nuanced approach to patent protection of clinical trial-related inventions. Written in partnership with J A Kemp, a leading firm of European patent, trade mark and design attorneys, this whitepaper aims to provide some patent filing considerations and highlights the importance of engagement and co-ordination of the legal and regulatory teams early on, and throughout the life cycle of clinical trials, to optimise patent filing opportunities.

Download the Whitepaper

Patent Filing Considerations in View of Revised Clinical Trial Regulation Transparency Rules

Whitepaper

Navigating the Landscape of Clinical Trial Applications under the EU Clinical Trials Regulation: Insights and Challenges

Ahead of the 31st of January 2024, marking a year until all EU clinical trials need to be compliant with the EU Clinical Trials Regulation (CTR). This whitepaper delves into different aspects we have observed that can become ‘sticking points’ for Sponsors wanting to conduct clinical trials under the CTR. Our analysis has highlighted six key topics, encompassing our experience of the overall clinical trial application (CTA) assessment process, data transparency and publication, transitioning from the Clinical Trial Directive (CTD) to the CTR, the EU CTR Systems Environment, EU Legal Representative requirements, and Article 32 paediatric requirements.

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Need personalised assistance to prepare for the new regulation? Contact our experts at hello@dlrcgroup.com

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Article

EMA Adoption of Revised CTIS Transparency Rules

Transparency is a central objective of the Clinical Trials Regulation (CTR); however, this must be balanced with confidentiality concerning personal data and CCI.

The EMA consultation and resulting revised transparency rules have considered the views and experience of stakeholders, enabling further optimisation of the rules to improve CTIS user experience and facilitate access to clinical trial information whilst maintaining the balance of confidentiality.

Read the article

EMA Adoption of Revised CTIS Transparency Rules

DLRC Regulatory Consultancy has staff with extensive experience working under the CTD, and we are ready to support you in your transition to operating under the EU CTR. We have in-house subject matter experts on the CTR, with experience working in the European Medicine Agency‘s (EMA) CTIS Business team and successful experience working with several clients on their CTR implementation programmes. We completely understand the new requirements and what you will need to change to be compliant and confidently operate under the CTR.

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