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Publishing Database

Publishing Database Quiz

Test your knowledge with our comprehensive quiz on publishing databases, covering various topics such as submission requirements, validation tools, and regional specifics. This quiz is designed for professionals in the pharmaceutical and regulatory fields.

Key Features:

Multiple choice questions
Covering a range of topics specific to Australia and Europe
Interactive and informative

16 Questions4 MinutesCreated by EvaluatingEagle572

1. What 'Sequence Description' would you expect to have for a AU RMP?

Initial

Product Information

RMP (version) & (date)

Risk Management Plan Australia

2. What is the date for Australia MAAs to be mandatory to be submitted in eCTD format?

Sep 2019

Jan 2021

May 2022

Not defined

3. Which of these regions have portals to submit via?

South Africa and Jordan

Thailand and Saudi Arabia

Saudi Arabia and Qatar

Qatar and Oman

4. Which of these countries do NOT allow Tablets and Capsules in the same eCTD application?

Jordan

Bahrain

Thailand

Switzerland

5. Which of these is NOT a possible application number for Saudi Arabia for the published output?

Hg#####

Hn#####

H#####

Hx#####

6. Which validation tool does AU use?

Lorenz

EURS Extedo Validator

VNeeS Checker

Insight Validator

7. What is the accepted submission types in Switzerland?

NeeS and eCTD

ECTD and Paper

Swiss eDOK and eCTD

Swiss eDOK

8. What is the maximum file size for a AU m1 document?

100MB

200MB

1GB

200GB

9. Which of these is NOT an acceptable output naming convention for the 32s7-stab section?

Stability-summary

Stability-datasets

Stability-data

Postapproval-stability

10. Which documents for AU require 3 levels of bookmarks?

PIs

PIs, CMIs and SPCs

PIs and CMIs

RMPs

11. You are working on a AU Type H Minor Variation, you do not have a 1.4.1 document, what will the validation result be?

Error

Possible

Warning

Not Validated

12. What is the CESP requirements for Latvia?

No specific national requirements and No requirement for CD/DVD for submissions through CESP

All applications for marketing authorization, renewal, all types of variations (under national, decentralized or mutual recognition procedures) need to be submitted as e-dossier via CESP or written on CD/DVD.

Cover letter requires CESP number for a new application. No requirement for CD/DVD for submissions through CESP.

The submission of CD/DVD/Mail/Eudralink in parallel is not required

13. Which of these is NOT a possible submission unit for the EU metadata?

Initial

Reformat

Response

PSUR

14. Which of these is NOT a valid sequence description for a AU clinical trial application?

Response to Request for Information

Pre-Submission Meeting Package

Withdrawal

Initial

15. According to the Swiss naming conventions, which one of these folder names are NOT valid?

1224-formvariationrequiringnotification

1223-formstatusmaabroad

1222-formmanufacturerinfo

Ch-fovarnotif-var.pdf

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