This RAC Self-Assessment tool is intended to be used only as a guide to help you identify areas where you have a strong knowledge base and areas where you have less knowledge and experience. It is particularly useful in developing a plan of study and preparation to take an RAC examination, but in no way indicates your likelihood of passing an RAC examination.

There are 46 questions covering four domains:

• Strategic Planning
• Premarketing
• Postmarketing
• Interfacing

Note: The 46 questions covering the four domains are general and were developed as a synthesis of all four RAC exams. You should rank your knowledge in each area within the context of the specific exam you are considering (US, EU, CAN or General Scope).

About the RAC Exams

The RAC examinations address all regulated healthcare products (e.g. pharmaceuticals, medical devices, biologics, etc) and regulatory professional functions throughout the lifecycle of a product. The exams are balanced with respect to product types and general critical thinking skills of regulatory professionals. Generally, the exams are organized by domains which address strategic planning, premarketing, postmarketing and interfacing regulatory functions.

The three regional RAC Examinations (US, EU & CAN) are knowledge-based examinations addressing laws, regulations, policies and guidelines affecting regulated health products, including medical devices, pharmaceuticals, biologics and biotechnology in their respective regions. The RAC General Scope also is a knowledge-based exam. It tests general knowledge of the full product lifecycles for medical devices, IVDs, pharmaceutical and medicinal products and biologics as well as ICH, GHTF, WHO and ISO guidelines and standards.

Strategic Planning

Please use the following scale to rank your skill level in the tasks below.

1. Little or no knowledge; no direct experience
2. Some knowledge of area but limited current direct experience
3. Working knowledge (of regulation, guidances, process)
4. Good knowledge and understanding, current involvement in area but not expert
5. Extensive knowledge and experience

Premarketing

1. Little or no knowledge; no direct experience
2. Some knowledge of area but limited current direct experience
3. Working knowledge (of regulation, guidances, process)
4. Good knowledge and understanding, current involvement in area but not expert
5. Extensive knowledge and experience

Postmarketing

1. Little or no knowledge; no direct experience
2. Some knowledge of area but limited current direct experience
3. Working knowledge (of regulation, guidances, process)
4. Good knowledge and understanding, current involvement in area but not expert
5. Extensive knowledge and experience

Interfacing

1. Little or no knowledge; no direct experience
2. Some knowledge of area but limited current direct experience
3. Working knowledge (of regulation, guidances, process)
4. Good knowledge and understanding, current involvement in area but not expert
5. Extensive knowledge and experience