Live Webinar European Data Protection Regulation – 2018 Implementation

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 90 Min Live Webinar

"Hear By Angela Bazigos who recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom"

European Data Protection Regulation

Description

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?

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.  
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

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

Areas Covered

•     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

Who will Benefit

Anyone that has cause to exchange client or patient data with a European location. Regulators both domestic and international. 

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Angela Bazigos

Angela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media. Co-authored & prototyped 21 CFR 11 guidance with FDA.  Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom. National Trainer 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 Life Sciences.

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