최신 RAC-US 무료덤프 - RAPS Regulatory Affairs Certification (RAC) US

A. The product must not be in accord with the specifications of the foreign purchaser.

B. The product must not be in conflict with the laws of the country to which it is intended for export.

C. The product must not be sold or offered for sale in domestic commerce.

D. The product must not be labeled on the outside of the shipping package that it is intended for export.

A. Quality

B. Production

C. Regulatory

D. Analytical

A. Request an inspection from a regulatory authority.

B. Request documentation from the sub-contractor.

C. Ask the vendor to take responsibility.

D. Document and perform audits.

A. IEC 60601

B. ICH guidelines

C. WHO guidelines

D. ISO 13485

A. Product distribution

B. Plasma fractionation

C. Plasma pooling

D. Individual plasma donation

A. Systematic procedure to review published scientific journals

B. Vigilance procedure to ensure the full traceability of the products

C. Systematic procedure to review experiences with the products in use

D. Vigilance procedure to notify the regulatory authorities about serious incidents

A. A major safety finding from a newly completed animal carcinogenicity study

B. A statistically significant increase in the number of deaths in an animal dose finding study

C. A clinically important increase in the rate of occurrence of an "expected." but serious
ADR

D. A lack of efficacy with a medicinal product used in treating a life-threatening disease

A. Acknowledge receipt of the letter in a written response but do nothing further.

B. Inform Company X that it has no right to send such a letter and do nothing further.

C. Inform the local regulatory authority of the letter and discuss how to respond.

D. Inform the legal department of the letter and discuss how to respond.

A. Literature search

B. Adverse event reports

C. Clinical experience

D. Clinical investigations

A. Although the regulatory authority reviews and approves drugs for specific indications, the approval does not limit the use of those drugs in clinical practice.

B. The peer-reviewed literature can ensure high-quality off-label promotion of medications, thereby increasing access to much needed drugs and devices.

C. Sponsors are allowed to distribute publications about unapproved uses of approved drugs and devices as long as the marketing application is under review by the regulatory authority.

D. The regulatory authority does not restrict physician prescribing for off-label indications or regulate the manufacturer's promotion for such use.