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RAC US Practice Test PowerPoint Presentation
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RAC US Practice Test

RAC US Practice Test

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RAC US Practice Test

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  1. Regulatory Affairs Certification (RAC) US

  2. What is RAC? Regulatory affairs (RA), also called government affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, biologics and functional foods). Regulatory affairs (medical affairs) professionals (aka regulatory professionals) usually have responsibility for the following general areas:

  3. Ensuring that their companies comply with all of the regulations and laws pertaining to their business. Working with federal, state, and local regulatory agencies and personnel on specific issues affecting their business. i.e. working with such agencies as the Food and Drug Administration or European Medicines Agency (pharmaceuticals and medical devices); The Department of Energy; or the Securities and Exchange Commission (banking). Advising their companies on the regulatory aspects and climate that would affect proposed activities. i.e. describing the "regulatory climate" around issues such as the promotion of prescription drugs and Sarbanes-Oxley compliance

  4. Certifications Regulatory Affairs Certification (RAC)

  5. Pass your exam in first attempt by the help of Here are some questions that will help you in your exam.

  6. Question No 1: Which is not a division of the FDA? A. CDRH B. CDER C. CFER D. CVM Answer: C

  7. Question No 2: What is the mission of the FDA? A. Promote public health B. Protect public health C. Pursue international harmonization D. All of the above Answer: D

  8. Question No 3: Which Congressional Act provided Statutory Authority to FDA to regulate medical devices? A. Safe Medical Devices Act of 1990 (SMDA) B. Medical Device User Fee and Modernization Act of 2002 (MDUFMA) C. Federal Food, Drug, Cosmetic Act (FDC Act) D. Medical Device Amendments of 1976 (MDA) Answer: D

  9. Question No 4: In order of highest level to lowest level, the ranking at US governmental organizations is: A. Division, Office, Center, Agency, Department B. Department, Agency, Center, Office, Division C. Center, Department, Division, Agency, Office D. Agency, Center, Office, Department, Division Answer: B

  10. Question No 5: Your company is developing a new drug to be developed and used in combination with a cystoscopy light device for the early detection of bladder cancer. You are asked to develop an overall regulatory strategy. The first step you undertake is: Submit a Request for Designation to FDA Office of Combination Products for determination of the lead center for primary jurisdiction for the combination product B. Make a preliminary internal company determination of the combination product's primary mode of action C. Submit an IND along with a Request for Designation to FDA CDER Office of Oncology Drug Products (OODP) D. Submit a request for designation to FDA CDRH and notify the Office of Combination Products Answer: B

  11. Question No 6: For nonclinical studies lasting more than 6 months, quality assurance audits are conducted at which of the following intervals? A. 1 month B. Quarterly C. At completion D. Periodically Answer: D

  12. Question No 7: Good Laboratory Practices Regulations govern the: A. Conduct and control of laboratory activities B. Conduct of nonclinical laboratory studies C. Determination of product efficacy in animals D. Determination of product feasibility Answer: B

  13. Question No 18: Consent from subjects for clinical study enrollment is a: A. Proposed rule B. Final rule C. Recommendation D. Guideline Answer: B

  14. Question No 9: All of the following are requirements of an IRB, EXCEPT A. Has at least 5 members B. Includes at least 1 nonscientific member C. Obtains informed consent from all subjects D. Represents the cultural mix of the community Answer: C

  15. Question No 10: Financial Disclosure is required for investigators who, during the time the clinical investigator is carrying out the study and for one year following the completion of the study, have: Been a prior employee of the sponsor company and own stock worth more than $50,000 USD B. Been paid $15,000 USD for conducting clinical trials with the sponsor C. A spouse who has been paid as a consultant by the company before the study began D. Is not a requirement for Phase 2 studies Answer: A

  16. Stairs To Your Success

  17. Regulatory Affairs Certification (RAC) US