Drug Delivery Device and Combination Product Risk Management and Safety Assurance Cases - Taiwan
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Group Registration
Effective risk management is a new challenge for many drug/biologic companies as they become drug/biologic and combination product manufacturers from traditional drug/biologic manufacturers. In addition, constructing safety assurance cases helps to ensure the completeness and correctness of risk management results and the adequacy of the risk management process. When being proactively developed, safety assurance cases become an effective method to improve risk management effectiveness.
This new training course will help you explain in depth effective risk management principles, drug delivery combination product best practices and tools, including Hazard Analysis, Fault Tree and Reliability Analysis, Design/Process FMEAs, Use Error Risk Analysis, and Safety Assurance Cases, from effectiveness and regulatory compliance perspective.
- Recognize challenges and opportunities for effective risk management of drug delivery combination products
- Apply knowledge on how to use risk analysis tools such as: Hazard Analysis, Fault Tree and Reliability Analysis, FMEAs, and Error Risk Analysis
- Identify risk controls effectively and efficiently for drug delivery of combination products
- Indicate the appropriate elements of safety assurance cases that may be useful to demonstrate safety and facilitate communications with regulatory reviewers during premarket reviews
- Identify industry best practices in managing risk and assuring safety through product life cycle
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Member Price
USD $899GovernmentMember Only
USD $899
Health AuthorityMember Only
USD $899
AcademicMember Only
USD $899
Non-Member
USD $899
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.
Grand Victoria Hotel
No. 168, Jingye 4th Road, Zhongshan DistrictTaipei City, Taiwan , Taiwan
A block of rooms have been reserved for meeting participants. The rate is NT $4,500 inclusive of taxes and breakfast. Reservations must be secured by Friday, October 11, 2019. After this date, reservation can be made on a space and rate available basis only.
To reserve a room at the group rate please email [email protected] and include that you are booking to attend PDA Taiwan 2019.
Individual Cancellation
Please be aware that obtaining and cancelling hotel reservations is the responsibility of the registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 3 days in advance of arrival unless otherwise specified on your reservation information.
Please visit the hotel’s website for more information.