Changes to the GDPR and Clinical Trials - What do You Need to Know?

On-Demand Workshop

The Data Protection Directive originally implemented in the EU in 1995 was recently replaced by the General Data Protection Regulation (GDPR). How does this affect your clinical trials? What do you need to know?

The discussion includes:

  • What is GDPR?
  • Explanation of increased scope on regulations
  • Data subject rights
  • How to design privacy into clinical studies
  • Live Q & A session

 

About the Presenters:

Diane Gleinser 85x105 rightDiane Gleinser is the Senior Vice President of Life Science Services and Solutions at USDM Life Sciences. Diane has more than 27 years of experience in life science-based industries, encompassing quality assurance, quality control, validation and regulatory compliance for research and development, clinical affairs, manufacturing and packaging, laboratory setup and analysis, and auditing under cGMP, cGLP and cGCP regulations and 21 CFR Part 11.

 

 

 

Erin Northington 85x105 rightErin Northington is Vice President of Emerging Life Sciences and Clinical at USDM Life Sciences. Erin has two decades of experience in Clinical Applications, Business Relationship Management and Project Management. She also has a background in GCP compliance, vendor evaluation and management, systems validation and implementations, as well as process evaluation and improvement. She specializes in managing global enterprise-wide IT implementations of technology solutions.

 

 

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
See all Testimonials