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European Data Protection Regulation – 2018 Implementation
• What is EU Data Protection Regulation & Why is it Important
• Why Does Europe Need Data Protection Regulation
• Key Concepts
• How EU Data Protection Regulation simplify existing rules
• How EU Data Protection Regulation strengthen citizens’ rights
• How EU Data Protection Regulation adapt data protection rules to new technological developments
• How EU Data Protection Regulation affect social networks
• How EU Data Protection Regulation benefit existing European business
• How EU Data Protection Regulation strengthen the internal market
• How EU Data Protection Regulation impact international co-operation
Overview of the webinar
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 needs to be secured and protected.
Similarly for data about patients in clinical trials
What really happens to this data?
Every day within the EU, businesses, public authorities and individuals transfer vast amounts of personal data across borders. Conflicting data protection rules in different countries would disrupt international exchanges.
Who should attend?
Anyone that has cause to exchange client or patient data with a European location. Regulators both domestic and international.
Any company that has cause to exchange client or patient data with a European location.
Examples: Pharma, Biotech, Medical Device, Food, Hospitals, Manufacturers, Finance Companies etc.
European companies. Other companies whose government will adopt the European data regulation.
Any company that collects and manages personal data including life sciences companies such as Roche, Proctor & Gamble, Johnson & Johnson, Stryker, Baxter, Novartis, Amgen, Abbott and others.
Why should you attend?
Attendees will learn the common EU rules that have been established to ensure that personal data has a high standard of protection across the EU. Attendees will also learn about their rights to complain and obtain redress if their data is misused in any of the EU member states.
Individuals in the EU may be unwilling to transfer personal data outside the EU if they are uncertain about the level of protection in other countries. How US businesses need to pay attention to this impact will be addressed.
On 4 May 2016, the official texts of the Regulation and the Directive have been published in the EU Official Journal in all the official languages. While the Regulation will enter into force on 24 May 2016, it shall apply from 25 May 2018. The Directive enters into force on 5 May 2016 and EU Member States have to transpose it into their national law by 6 May 2018.
Faculty - Mz.Angela Bazigos
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 Life Science Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediation 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 Life Sciences industry.