New England Chapter: GDPR Implementation in Clinical Trials

When:  Dec 17, 2019 from 12:00 PM to 01:00 PM (ET)
Associated with  ACRP New England Chapter
GDPR Implementation in Clinical Trials

Please click here to purchase your contact hour.

  • Natasa Spasic, Quality and Compliance Officer, Data Protection Officer, Pharm-Olam International Deutschland
Target Audience:
  • CRCs
  • CRAs
  • Investigators
  • Auditors
  • Project Managers
  • Regulatory Affairs/Compliance
  • Data Managers (Site, Sponsor, CRO)
  • Medical Monitor, Medical Officer, Project Physician
  • Quality Assurance
  • Clinical Research Administrators
  • Other
Program Description:
This 60-minutes session is aimed at providing an overview of the General Data Protection Regulation (GDPR) and translating its specific requirements into a clinical trial environment. The session will provide useful information in regards to different roles of various clinical trial parties and their responsibilities. Attendees can gain knowledge on how this impacts them and their organizations, and learn about the measures that they need to have in place to comply with the GDPR. Additionally, the current status of different EU country implementations of this regulation will also be covered in general, as well as the different positions of EU regulatory bodies in regards to clinical trial requirements. This session will provide practical solutions to GDPR implementation within the clinical trial environment. Attendees will be provided with a GDPR Assessment Checklist for both Controllers and Processors (and an additional document on Roles & Responsibilities, upon request).

Program Agenda:
11:45 AM - Webinar setup
12:00 - 1:00 PM Educational Presentation

Learning Objectives:
  1. Understand general requirements introduced by the General Data Protection Regulation (GDPR)
  2. Understand its effects on clinical trials
  3. Know specifically which steps need to be taken to ensure clinical trials are GDPR compliant

Contact hours: 1.0 Contact hours have been applied for through ACRP.

Membership is not required for online registration of contact hours.

To receive contact hours: Purchase the contact hours, sign in at the event, and attend the program. Log on to the ACRP website then “My Courses” to complete the evaluation no later than 30 days following the event and obtain the online certificate.

Registration Cost: FREE to all Chapter Members, ACRP Members, Non-Members

Contact Hour Cost:

  • $0 Chapter Members
  • $15 ACRP Members
  • $30 Non-Members

Refund Policy: Not applicable


Online Instructions:
Login: Dial by your location +1 929 205 6099 US (New York) +1 669 900 6833 US (San Jose) Meeting ID: 834 100 331