General Data Protection Regulation (GDPR): Compliance for Clinical Trials

Duration: 60 Minutes
flat 40% off on this webinar use promo code
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.
General Data Protection Regulation
Instructor: Laura Brown
Product ID: 504021
To ensure effective compliance by 25th May, 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.

Objectives of the Presentation
  • Attain an understanding of the General Data Protection Regulation (GDPR)
  • Be able to understand the key of the main tenets of GDPR which impact on clinical trials
  • 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
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.
In addition, the session will help you develop your awareness of non-compliance with the new GCPR regulation fines: 4% of global annual turnover or €20 million.

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 trials
  • Risk and compliance managers responsible for clinical trials
  • Internal legal teams with responsibility for clinical trials
$375
Recorded Session for one participant
Get life time access with download option!
Book this course
Pay Now
  $500.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $600.00 Training USB Flash Drive
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years’ experience of quality assurance and regulatory requirements in clinical trials in the pharmaceutical industry. She has worked in senior positions for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality systems including data protection and data integrity in clinical trials. She was Chairman of the ACRPI GCP Forum for six years. She regularly writes on pharmaceutical regulatory issues in clinical trials.
View More