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Wednesday, April 11 • 8:30am - 10:00am
Session M - I.T. Compliance Track

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M-1  FDA & Industry: The Patient Will See You Now!!

The New Health Economy requires that pharmaceutical and life sciences companies and their chief regulator the Food and Drug Administration, collaborate to meet 21st century demands which are seeing much more sophisticated & informed Patients (consumers). Executives and regulators should seize upon this momentum to build closer relationships and facilitate more meaningful communications around product development and review. A greater reliance on public private partnerships could also provide a forum for the exchange of ideas.
This presentation will describe the ultimate consumer, the Patient, and discuss patient expectations for 21st century health care. It will then present a case for closer collaboration and mutual training between FDA and industry to ensure America’s perch as a global leader in medical innovation and to stimulate the next generation of treatments and cures and  meet patient needs. FDA has already started such a program. This presentation it will give the latest information on existing collaboration efforts between FDA and industry and their benefit and will present ways to further strengthen the relationship between the two to serve the Patient.


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M-2  Cyber Security & Business Continuity in the Cloud

When it comes to cyber security and the thread of being attacked, it's a matter of "when" and not "if". If you're plugged in then you're vulnerable, and if you're vulnerable hackers are already looking for you.  For Life Science companies this is especially challenging because regulation requires your systems be secure and readliy available for consistent intended performance.  Not only must they be secure, you must also be able to recover in the event of a disaster, including catestrophic disasters.  One may think the best solution is to maintain control of all computer servers, protecting the equipent inside a physical fortress that is enhanced with virtually inpenetrable logical shields.  That sounds good but the biggest problem here is what's already inside your walls.  This presentation will identify the threats we face regarding cyber security, and measures we can take to mitigate them.  The challenges we face with business continuity, and how to conquer them.  Finally, the fear we face with cloud-based solutions, and how to overcome them.  Attendees will walk away with a better understaning and a high-level plan of action they can take back to their organization to begin strengthing the company's defense mechanisms, and leveraging technology to promptly recover in the even of a disaster, including the use of cloud based technologies.  

IT Compliance

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Angela Bazigos

Touchstone Technologies, Inc.
Angela Bazigos is the 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... Read More →

Jane Kreis

U.S. Food & Drug Administration, Office of Regulatory Affairs, Pacific Region
avatar for Steven Thompson

Steven Thompson

Sr. Manager, Prof. Svcs., ValGenesis, Inc.
Just mention auditing, validation, CSV, technology, Artificial Intelligence / Machine Learning, cybersecurity, scuba diving, or animals (especially dogs & elephants) and we'll have a great conversation.

Wednesday April 11, 2018 8:30am - 10:00am PDT
Platinum 3&4