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

5/5
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:

Our GDPR certified training is tailored to meet the specific needs of life sciences organizations, providing comprehensive guidance to navigate the complexities of data protection regulations in Europe. This course equips you with the tools to ensure compliance with EU standards in clinical research, pharmaceutical development, and healthcare, protecting data, building trust, and avoiding costly penalties.
This course provides also a comprehensive overview of the principles and requirements for transferring personal data from the EU to the US, focusing on maintaining compliance with GDPR standards throughout the clinical trial lifecycle.

 

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.

 

Topics outlined in the course:

  • Managing personal data according to GDPR standards.
  • Obtaining and managing consent in line with GDPR standards.
  • Ensuring the rights of data subjects are upheld.
  • Conducting effective Data Protection Impact Assessments (DPIAs).
  • Managing Transfers of Clinical Data from EU to US organizations.

 

Each session integrates real-life examples and assessments to facilitate a comprehensive and applied learning experience. Upon completion, participants will receive a globally acknowledged GDPR in Life Sciences training certificate, accredited with CPD/CEU credits. 

 

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:

5/5
19
USD: United States (US) dollar ($) ^

$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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