Bridging the Gap: 2026 Regulatory Alignment for Clinical Trials in EU-IL

​Webinar:

Regulatory Compliance in Clinical Trials, Essential Brief for In-House Counsel & Compliance Officers

​I. The Regulatory Landscape

• ​Frameworks: EU CTR (CTIS), FDA (21 CFR), and ICH GCP updates.

• ​Risks: Penalties, lawsuits, and data invalidation.

​II. Legal & Ethical Requirements

• ​Informed Consent: Ethical requirements (CTR) vs. Data privacy (GDPR).

• ​Data Protection: Anonymization and pseudonymization standards.

​III. Operational Compliance

• ​Deviations: Reporting and managing protocol deviations.

• ​Data Integrity: Documentation standards and Electronic Signatures (Part 11).

• ​Safety: Pharmacovigilance and expedited AE/SAE reporting.

​IV. Contractual & Financial Legalities

• ​CTAs: Negotiating Liability, Indemnity, IP, and Publication.

• ​Transparency: Financial disclosure and IRS compliance.

​V. Audits & Future Trends

• ​Inspections: Preparing for FDA/EMA audits and mock inspections.

• ​AI & Tech: Impact of the EU AI Act and new FDA guidance.

​VI. Q&A and Conclusion