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Who should attend EU GDPR Deadline is Just around the Corner: Understanding Compliance for Clinical Trials for Life Sciences Companies
Anyone working in clinical trials including managers and quality assurance personnel seeking to gain knowledge of the GDPR requirements applicable to clinical trials
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Anyone working in clinical trials including managers and quality assurance personnel seeking to gain knowledge of the GDPR requirements applicable to clinical trials

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Seminar Summary:

This webinar on the GDPR will help you understand how it will apply to clinical trials and judge your preparedness before the due date. (see full course description)

 
 
 

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Training Course Syllabus:


The General Data Protection Regulation (GDPR) is new legislation that comes into force on 25th of May 2018 which brings substantial changes to the rules around personal data and its use. While it builds on existing Data Protection legislation, it represents a significant change for organizations that hold and process personal data such as clinical trial data, with regulators poised to impose much heavier fines for noncompliance-in the most serious cases as high as €20m or four percent of worldwide turnover. Pharmaceutical and biotechnology organizations, vendors including CRO, and study sites need to ensure management and staff understand the requirements of the GDPR and are well equipped to plan, implement and maintain a data protection compliance program for running clinical trials. Organizations collecting clinical trial data will also need to appoint a suitably qualified and trained data protection officer (DPO). This webinar on the GDPR will help you understand how it will apply to clinical trials and judge your preparedness before the due date.

Objectives of the Presentation

Attain an understanding of the General Data Protection Regulation (GDPR) and how it applies to life sciences companies
Update on the latest guidance and key points in run up to the deadline date
Be able to understand the key of the main tenets of GDPR which impact on clinical trials
Key considerations for US life sciences companies:
Operating clinical trials in the EU
Using health data from EU patients
Engaging with healthcare professionals in the EU
Marketing to, and engaging with, EU patients
Processing European employee data in line with GDPR
Consider data breaches
Understand the role of the Data Protection Officer (DPO)
Ascertain how the new rules around GDPR apply to your organization
Have greater ability to identify potential impacts of privacy challenges for running clinical trials
Review the new governance and technical steps in your organization to comply with the GDPR requirements

Why Should you Attend

Many US life sciences organizations, even those without a European occurrence, will be specifically affected and need to take steps in very short order to comply with GDPR necessities relevant to many aspects of their business. By attending this webinar you will be better prepared to comply with the new regulation, as well as understand the key areas, concepts, principles, terms and definitions used in the GDPR relevant to clinical trials.

Areas Covered

Essential overview and background of the EU General Data Protection Regulation (GDPR)
Understand how it will apply to clinical trials and the pharma industry
Special categories of personal data includes clinical trial data
The rights of clinical trial subjects, including data access requests, informed consent
Controllers & Processors
Reporting data breaches
The role of the Data Protection Officer (DPO)
Transferring clinical trial data outside the EU
Penalties
Considerations for governance to comply with the GDPR requirements

Who will Benefit

Anyone working in clinical trials including managers and quality assurance personnel seeking to gain knowledge of the GDPR requirements applicable to clinical trials, or those who currently have a role in data protection or information security and need to understand how to comply with the regulation or clinical trials. Roles include: Clinical Research Managers, VPs and Directors, Quality Assurance for clinical trials /GXP, Study site staff, CROs and other vendors working on clinical trials, Data management, Pharmacovigilance , for clinical trials, Information security managers, Data protection officers, IT and corporate security managers, Corporate governance managers responsible for clinical , and compliance managers responsible for clinical trials, Internal legal teams with responsibility for clinical trials, In-House Lawyers, Compliance , Professionals in Life Science Companies

Seminar Summary:

This webinar on the GDPR will help you understand how it will apply to clinical trials and judge your preparedness before the due date. (see full course description)

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