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
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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