Cybersecurity Risk Management for Drug Delivery Combination Products
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Individual Registration
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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.
- Explain why cybersecurity is important and how it applies to drug delivery combination products
- Demonstrate how to perform pre-market cybersecurity risk analysis by using tools for drug delivery combination products
- Demonstrate how to manage post-market cybersecurity through product lifecycle by conducting a post-market risk assessment and evaluation
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Standard Pricing
Standard Member Price
$1,399GovernmentMember Only
$839
Health AuthorityMember Only
$839
AcademicMember Only
$839
Non-Member
$1,679
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.
GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.
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].
Day 1
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.
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Request InformationPLEASE 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 NWWashington, DC , USA
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.
Please visit the hotel’s website for more information.