Podcast
Questions and Answers
How long does the pre-clinical studies phase typically last in drug development?
How long does the pre-clinical studies phase typically last in drug development?
- Approximately 8 years
- Approximately 4 years (correct)
- Approximately 6 years
- Approximately 2 years
In which phase of drug development are experiments conducted on patients numbering between 100-200?
In which phase of drug development are experiments conducted on patients numbering between 100-200?
- Phase II (correct)
- Phase I
- Phase III
- Pre-clinical studies
What is the estimated cost of researching and developing a new chemical or biological entity in euros according to the text?
What is the estimated cost of researching and developing a new chemical or biological entity in euros according to the text?
- € 4,000 million
- € 3,000 million
- € 1,926 million (correct)
- € 2,558 million
How many healthy subjects are typically involved in Phase I of drug development?
How many healthy subjects are typically involved in Phase I of drug development?
During which phase in drug development does the EMA evaluation typically take place?
During which phase in drug development does the EMA evaluation typically take place?
Which phase of drug development involves patients ranging from 1000-3000 individuals?
Which phase of drug development involves patients ranging from 1000-3000 individuals?
What is the purpose of the Scientific Advice (SA) procedure mentioned in the text?
What is the purpose of the Scientific Advice (SA) procedure mentioned in the text?
When can Scientific Advice (SA) be requested during drug development?
When can Scientific Advice (SA) be requested during drug development?
What entities can be involved in parallel with the Scientific Advice procedure?
What entities can be involved in parallel with the Scientific Advice procedure?
Is the scientific advice provided legally binding throughout the EU?
Is the scientific advice provided legally binding throughout the EU?
How long does it take for the Scientific Advice procedure to be finalized?
How long does it take for the Scientific Advice procedure to be finalized?
What types of methodologies/biomarkers can be qualified through Scientific Advice?
What types of methodologies/biomarkers can be qualified through Scientific Advice?
What is the key difference between conditional approval and approval under exceptional circumstances?
What is the key difference between conditional approval and approval under exceptional circumstances?
What is the characteristic of the legal basis in the context of strategic choices mentioned in the text?
What is the characteristic of the legal basis in the context of strategic choices mentioned in the text?
What determines the fees in the Centralised Procedure according to the provided text?
What determines the fees in the Centralised Procedure according to the provided text?
Which procedure allows for adding new Member States as required, as discussed in the text?
Which procedure allows for adding new Member States as required, as discussed in the text?
What aspect makes Centralised Procedure more efficient according to the text?
What aspect makes Centralised Procedure more efficient according to the text?
In what way does Approval under exceptional circumstances differ from Conditional approval based on the text?
In what way does Approval under exceptional circumstances differ from Conditional approval based on the text?
What is the purpose of encouraging Scientific Advice (SA) early in development or at major transition points?
What is the purpose of encouraging Scientific Advice (SA) early in development or at major transition points?
When should specific questions be asked regarding Scientific Advice (SA)?
When should specific questions be asked regarding Scientific Advice (SA)?
What was the average assessment time required for the centralized procedure in 2021?
What was the average assessment time required for the centralized procedure in 2021?
Why is authorization of new medicines considered essential according to the text?
Why is authorization of new medicines considered essential according to the text?
When should interactions with regulators be established according to the text?
When should interactions with regulators be established according to the text?
How many medicines were recommended for marketing authorization by EMA in 2021?
How many medicines were recommended for marketing authorization by EMA in 2021?
What types of questions do companies typically ask before the first marketing authorisation (MA)?
What types of questions do companies typically ask before the first marketing authorisation (MA)?
What is the primary focus of Scientific Advice given by the Committee for Medicinal Products for Human Use (CHMP)?
What is the primary focus of Scientific Advice given by the Committee for Medicinal Products for Human Use (CHMP)?
How often does the Scientific Advice Working Party (SAWP) meet throughout the year?
How often does the Scientific Advice Working Party (SAWP) meet throughout the year?
What is the basis for membership in the Scientific Advice Working Party (SAWP)?
What is the basis for membership in the Scientific Advice Working Party (SAWP)?
Which regulatory bodies or organizations does the Scientific Advice Working Party (SAWP) interact with according to the text?
Which regulatory bodies or organizations does the Scientific Advice Working Party (SAWP) interact with according to the text?
What type of medicines receive significant benefit before the first marketing authorisation?
What type of medicines receive significant benefit before the first marketing authorisation?
