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Cybersecurity Risk Management for Drug Delivery Combination Products

Sep 20, 2019
Washington, DC

  • Education
  • The Americas


Cybersecurity vulnerabilities introduce a new category of risk to our patients, company business and healthcare system as a whole. More and more traditional drug manufacturers are entering drug delivery combination products. The advancement of digital health draws many drug delivery combination products into the connected healthcare ecosystem. As such, cybersecurity has become an important part of the risk management program for drug delivery combination product manufacturers.

In responding to public and governmental concerns, FDA has been increasing focus on cybersecurity. Multiple FDA cybersecurity guidance documents have been released within recent years in expecting manufacturers to address cybersecurity in pre-market submissions as well as post market management throughout product life cycle.

Many existing safety risk management principals and processes can be applied and leveraged for cybersecurity risk management. However, cybersecurity risk management does require a new set of disciplines and skills that manufacturers may not be familiar with or experienced in.

This training course explains cybersecurity risk management principles with comparison to safety risk management. Attendees will walk through methods and associated tools to identify, assess and control cybersecurity risks using drug delivery combination product examples. Best practices on how to properly document cybersecurity for effectiveness and regulatory compliance, as well as key cybersecurity related industry standards, technical reports, and FDA guidance will also be discussed.

The training course provides lecture slides, examples, drug delivery combination product case studies and interactive group exercises for participants to apply their new knowledge and hear feedback from both the trainer and FDA. Participants will also have the opportunity to interact with FDA on questions related to drug delivery combination product cybersecurity.


  • Training courses run from 8:30 to 16:00 each day, unless otherwise noted. An agenda will be provided on the first day of the training course.


Seth Carmody
Seth Carmody
U.S. Food and Drug Administration
Fubin Wu
Fubin Wu

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Explain why cybersecurity is important and how it applies to drug delivery combination products
    2. Demonstrate how to perform pre-market cybersecurity risk analysis by using tools for drug delivery combination products
    3. Demonstrate how to manage post-market cybersecurity through product lifecycle by conducting a post-market risk assessment and evaluation
  • Who Should Attend

    This training course is intended for professionals who are involved or are interested in cybersecurity risk management for drug delivery combination products.

    Quality, Research and Development, Regulatory Affairs

    Manager, Supervisor, Specialist

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PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Renaissance Washington, DC Downtown Hotel

999 9th Street NW
Washington, DC

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  • Accommodations

    Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room!

    A block of rooms have been reserved for meeting participants at the Renaissance Washington, DC Downtown Hotel. The rate is $317 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Friday, August 16, 2019. After this date, reservations can be made on a space-and-rate available basis only. Check-in time is 4:00 p.m.; check-out time is 12:00 p.m.

    To make reservations, individuals may click on the reservation link above or call the Renaissance Washington, DC Downtown Hotel at +1 (202) 898-9000. Please make sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate.

    Individual Cancellation

    Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 3 days prior to the date of arrival by 6:00 p.m. (EST) to avoid cancellation fees.

  • Amenities

    Please visit the hotel’s website for more information.

How to Get Here

By Air

The Washington/Bethesda area is serviced by the following airports: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).

By Car

Renaissance Washington, DC Downtown Hotel is located on 999 9th Street NW off of New York Avenue.

Hotel Parking

$35 / Daily Self-Parking
$45 / Daily Valet Parking

Other Options


Gallery Place Metro Station is 0.5 miles away from the hotel and is approximately $2.50 one way to Reagan National.


Union Station is 1 mile away from the hotel. To book your reservation call Amtrak at +1 (800) 872-7245 or visit


Registration Fees

Early Registration
Registration Type Price By August 6, 2019
Member $1,259
Non-member $1,511
Gov't/Health Auth./Academic* $839

Regular Registration
Registration Type Price After August 6, 2019
Member $1,399
Non-member $1,679
Gov't/Health Auth./Academic* $839

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].


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