General Data Protection Regulation (GDPR) for Pharmaceuticals and Clinical Trials

Rated 5 out of 5
19
GDPR

Duration :

1

1 hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Successful completion provides learners with a dated, traceable and downloadable certificate for the course : 

Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker. They can also be shared on Linkedin.

Description:

Life‑sciences organizations handle some of the most sensitive personal data in the world, making GDPR compliance essential for protecting patient privacy, maintaining trust, and avoiding costly regulatory penalties. Clinical trials, pharmacovigilance activities, and global research collaborations all require a clear understanding of how GDPR applies to health data.Developed by experts in data protection and clinical operations, the course also covers international data transfers, especially EU‑to‑US transfers, ensuring compliance throughout the clinical‑trial lifecycle.

🚀 Upon successful completion, participants receive a downloadable, internationally recognized GxP training certificate, accredited with CPD/CEU credits, suitable for professional and HR records.

✅ Who should enroll?
This course is perfect for data protection officers, compliance managers, and clinical research professionals managing patient data. It also benefits regulatory affairs specialists, quality assurance personnel, and pharmaceutical or biotech professionals handling sensitive data, ensuring GDPR compliance across life sciences organizations.

🎯 What you’ll learn?

  • Apply GDPR principles to clinical research and pharmaceutical operations
  • Understand controller vs. processor responsibilities
  • Manage and document GDPR‑compliant consent
  • Uphold data‑subject rights throughout the trial lifecycle
  • Conduct effective Data Protection Impact Assessments (DPIAs)
  • Navigate EU‑to‑US clinical‑data transfers

 

Curriculum:

Introductory Video

Lesson 1: Personal Data in Clinical Research

Lesson 2: Controllers in Clinical Data Protection

Lesson 3: Processors in Clinical Data Protection

Lesson 4: Consent

Lesson 5: Rights of Data Subjects

Lesson 6: Data Protection Impact Assessment (DPIA)

Lesson 7: Handling International Transfers of Clinical Data

Conclusion

Evaluation

Author:

patricia kay
Dr. Patricia Kay
Dr. Patricia Kay is a results focused senior research management professional with over 20 years experience in the life sciences. She has a significant expertise in clinical development, health program management, strategic planning, stakeholder management, business unit operations and personnel management. Dr. Kay has a broad knowledge of cardiovascular disease, immunology, infectious diseases. She takes part in many startups boards.

Reviews:

Rated 5 out of 5
19

$95

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This course includes:
One-year access
Updated content every month
Certificate of completion

GxP-Training Benefits

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$95.00 / year

$95.00 / year

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