Webinar Duration: 60 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Angela Bazigos

OVERVIEW:
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.

Why should you Attend: 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. 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.

Areas Covered in the Session:
– 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

Learning Objectives:
– European Data Protection Regulation as a response to the digital age and new, rapidly evolving technologies, including social networks
– How citizens fundamental rights on personal information will be protected
– How the current fragmentation and costly administrative burdens of European regulatory authorities will be streamlined
– Benefits of the Regulation to European companies
– Impact of the Regulation on International Co-Operation between companies

Who Will Benefit:
– Anyone that has Cause to Exchange Client or Patient Data with a European Location
– Regulators both Domestic and International

SPEAKER PROFILE:
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer, http://morflearning.com/angelabazigos/, Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashxPatent on speeding up software compliancehttps://www.google.com/patents/US8266578 . Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroomhttp://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/ includes training for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for LifeSciences: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview.