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Vial to PFS Scenario

Create an illustration depicting pharmaceutical professionals collaborating on a vial to pre-filled syringe conversion project, with a focus on regulatory submissions and device information in a modern office setting.

Vial to PFS Conversion Quiz

Test your knowledge on the pharmaceutical product development process with our Vial to PFS Conversion Quiz. This quiz is designed for professionals and students alike who are interested in understanding the complexities involved in the transition from vials to pre-filled syringes (PFS) within the pharmaceutical industry.

Evaluate your understanding of key concepts.
Identify crucial data points in regulatory submissions.
Explore real-world case studies and their challenges.

11 Questions3 MinutesCreated by TransformingData423

Name:

In what phase of product development do most pharma activities occur

Device Selection

Regulatory Submission and Review

Combination Product Development

Planning

Which of the following would not be considered to be a key commercial driver for a Pharma company:

A. Increase the number of patients

B. Maintain the number of patients

C. Slow the decrease of patients who switch to new therapies

Access to new Technology

Who leads and is responsible for the combination product development process

Pharmaceutical company

Device Company

Jointly responsible

What kind of data is Pharma expecting from a device manufacturer?

Only data that is needed in a regulatory filing

Data that provides information on functional performance and test methods.

Data that is used for pharma to help them make decisions

All of the above

In the scenario, a clinical study was deemed not to be required for regulatory purposes for this vial to PFS conversion. Which of the following information would be the most likely critical data point in support of a submission?

Human Factors Summative Study

Successful CP Verification Report

Process Validation

Risk Management File

Which of the following Module 3 Sections from eCTD will contain Device information (choose all that apply):

3.2.P

3.2.Q

3.2.S

3.2.R

When considering information to provide a Pharma client for inclusion in their regulatory filing, which of the following device data could be directly leveraged by the Pharma client (choose all that apply):

Engineering Drawings

Biocompatibility Testing

Functional Performance

Compendia Requirements

In the Benlysta case study, they developed a safety PFS and an autoinjector What challenges did they face in the development. Check all that apply

A. Product was an IV infusion

B. Product was a SC injection using a vial with lyophilized powder

C. Competition from other companies

D. Dosing regimen based on weight

In the Xolair case study, they developed a PFS for their product . What challenges did they face in the development. Check all that apply

A. Product was an IV infusion

E. Product was a SC injection using a vial lyophilized powder

B. Patient adherence was important in this patient population

D. Complicated banded dosing regimen based on weight and other criteria move to fixed dosing

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