The EU General Data Protection Regulation (GDPR) significantly reshapes the data protection landscape for organisations worldwide that collect and process the data of European residents. The Regulation also imposes fines up to 4% of annual global turnover or €20 million (whichever is higher), grants extended rights to data subjects and allows data subjects to bring legal action against organisations in case of data breach.

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.

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.

Background:

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?

Course 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

Course Outline:

• 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

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Site Quality Operations Managers
• Quality Assurance personnel
• Plant Managers and Supervisors
• Manufacturing Superintendents and Managers
• Regulatory Affairs Managers
• Anyone that has cause to exchange client or patient data with a European location
• Regulators both domestic and international