Requirements for Demonstrating Compliance with the EU's General Data Protection Regulation GDPR

The GDPR (General Data Protection Regulation) is slated to go into effect May 25 of 2018 in the EU. There is no roll-in period as this has been in discussion since 2012. This new regulation will replace the existing EU regulation (Directive 95/46) on Data Privacy and dramatically extends the definition of privacy considerations for anyone doing business in the EU. It will have a sweeping impact on how the Internet and data are utilized for global business. The punitive measures associated with non-compliance are significant with a maximum fine of 20 million Euro or 4% of a firm's annual turnover, whichever is higher. This online presentation will discuss the key attributes of this new regulation and the required elements from an IT perspective and organizational perspective required to demonstrate compliance.

Bikash K. Chatterjee
President and CSO
Pharmatech Associates

Mr. Chatterjee has more than 30 years of experience in the veterinary, pharmaceutical, biosciences, medical device/diagnostic and nutraceutical/dietary supplement industries. He has held senior management positions in operating companies for more than a decade and has successfully brought multiple drug and product platforms through the FDA regulated development process to market. Throughout his career he has been responsible for the commercialization of over a dozen products which have been approved and marketed in over 40 different countries around the world.

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