Injectable Combination Product Integrated Development
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The regulation of combination products continues to evolve in the US and Europe with new practices that have greater scrutiny for safety and performance. The effectiveness and compatibility of the delivery device with the drug product is critical to patient safety. However, it is difficult to define the device inputs in early development when the drug formulation and dosing is not yet final. Pharmaceutical companies, device engineers, and suppliers have a common goal to identify risks to combination product quality with early planning to enable parallel development.
The aim of this training course is to bring together multiple viewpoints with a line of sight to finished combination product from early development through commercialization. A background on the requirements from different regulatory branches will be given, with a focus on Design Controls and Quality by Design alignment. Interactive discussion across various disciplines will bring to light the importance of early planning to address potential failures. There will be examples of making informed decisions about suitable performance and safety data at the right time in order to guide application information. This training course will provide practical experience on understanding the role of human factors, recognizing essential performance requirements, and qualifying primary container systems.
PDA Parenteral Packaging Training Courses
PDA Universe of Pre-Filled Syringes and Injection Devices Training Courses
- Explain the concept for integrated injectable drug-delivery system/device
- Merge aspects of Design Controls (DC) with Quality by Design (QbD)
- Identify considerations for contact material compatibility and safety
- Build line of sight data packages for delivery systems performance starting at development through regulatory approval
- Recognize goals for a total product life cycle (TPLC) model with feedback loops from inception
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Standard Pricing
Standard Member Price
$1,399GovernmentMember Only
$979
Health AuthorityMember Only
$979
AcademicMember Only
$979
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 generally run from 8:30 to 16:00 each day. Breakfast and lunch will be provided.
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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.
Rio All-Suites Hotel and Casino
3700 W Flamingo RoadLas Vegas, NV , 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 Rio Hotel and Casino. The rate is $149 for single or double occupancy. Guestroom rates are subject to discounted resort fee ($20 per night) and State and Local taxes.
Reservations must be secured by Friday September 4, 2020. 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 11:00 a.m.
To make reservations, individuals may click on the reservation link above or call the Rio Hotel and Casino at +1 (888) 746-6955. Be 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 in advance of arrival date, unless otherwise specified on your reservation information.
Please visit the hotel’s website for more information.