Topic : European Data Protection Regulation
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Overview
Whenever you open a bank account, join a social networking website or book a flight online, you hand over vital personal information such as your name, address, and credit card number. Personal data collected by life sciences companies from subjects participating in clinical trials need to be secured and protected.Similarly for data about patients in clinical trials. What really happens to this data?
Areas Covered in the Session:
- What is the EU Data Protection Regulation & Why is it Important
- Why Does Europe Need Data Protection Regulation
- Key Concepts
- How the EU Data Protection Regulation simplify existing rules
- How the EU Data Protection Regulation strengthen citizens? rights
- How the EU Data Protection Regulation adapt data protection rules to new technological developments
- How the EU Data Protection Regulation affect social networks
- How the EU Data Protection Regulation benefit existing European business
- How the EU Data Protection Regulation strengthen the internal market
- How the EU Data Protection Regulation impact international co-operation
Speaker Profile :
Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roche, Novartis, Genentech and PriceWaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compliance Officer, QA Director and has acted on behalf CEO for communications with FDA. Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to LifeScience Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. Has contributed to prototyping of 21 CFR 11 & CSV before promulgation to industry.
Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in speeding up software validation. She has been on the board for UC Berkeley's Business School for Executive Education in Life Sciences and is now on the Stanford Who's Who Registry for contributions to the Lifesciences industry.More recently, Ms Bazigos was quoted in the Wall Street Journal on Bringing Compliance to the Boardroom
Contact Info :
Compliance Key
https://www.compliancekey.us
Email : support@compliancekey.us
Phone : +1 717-208-8666
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