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How the EU CTR is Shaping the Future of Clinical Trials | Cromos Pharma
How the EU CTR is Shaping the Future of Clinical Trials: Insights and Key Challenges for Sponsors The landscape of clinical trials in the EU has undergone a significant transformation with the implementation of the EU Clinical Trials Regulation (CTR). While this regulation promises a more streamlined and transparent approach, it also presents new challenges for sponsors, particularly around managing transparency obligations, navigating complex regulatory processes, and ensuring compliance under the harmonized Read more
Do You Need a Data Protection Representative? Understanding GDPR’s Article 27 Requirement Key Takeaways: When is a DPR Required?: Non-EU companies processing data of EU residents are required to appoint a DPR under Article 27 of the GDPR. DPR’s Responsibilities: The DPR facilitates communication between non-EU companies, EU data subjects, and regulatory authorities. Consequences of Non-Compliance: Failure to appoint a DPR when necessary can result in penalties, Read more
GDPR Essentials: What You Need to Know About Appointing a Data Protection Officer Key Takeaways: DPO Role is Critical for Data Compliance: Appointing a DPO ensures that companies meet GDPR regulations, particularly for large-scale data processing. Key Responsibilities: The DPO advises the organization, monitors compliance, and manages risks related to data protection. Flexibility in Appointments: Companies may share a DPO or hire one part-time, depending on their size Read more
Mastering EU Regulatory Compliance: Key Roles of the LR, DPO, and DPR in Clinical Trials (Part 1) Key Takeaways: Understanding the Legal Representative’s (LR) Role: Essential for any non-EU company conducting clinical trials in the EU, the LR acts as the company’s point of contact with EU regulators. Ensuring Compliance: The LR assumes responsibility for overseeing the trial’s adherence to EU regulations, especially under the EU Clinical Trials Regulation (EU No. 536/2014). Read more
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