RAPS > RAC > RAC Self-Assessment Tool

This RAC self-assessment tool is intended to help identify your strengths and weaknesses with regard to your regulatory knowledge and experience. It is particularly useful in developing a plan of study, but in no way indicates your likelihood of passing an RAC examination.

There are 46 assessment areas covering four domains: strategic planning, premarketing, postmarketing and interfacing. The questions 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 Global).

Strategic Planning

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

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

General Tasks	Pharmaceuticals/ Biologics/ Medicinal Products	Medical Devices, IVDs
	Product Types
Evaluate regulatory environments and relationships and provide advice on requirements and considerations throughout the product lifecycle (linked to regulatory intelligence)
Risk/benefit analysis on product development concept for initial product viability
Endpoints for feasibility phase safety and efficacy testing in order to determine the ability to comply with regulatory standards
Evaluating regulatory history, background, classification and contexts to assess implications for approval
Identifying appropriate regulatory authority(ies) for submission and requirements
Anticipate regulatory obstacles and provide alternative strategies
SOPs for regulatory compliance (for regulatory and related departments)

Premarketing

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

General Tasks	Pharmaceuticals/ Biologics/ Medicinal Products	Medical Devices, IVDs
	Product Types
Regulatory requirements for quality, preclinical and clinical data
Communication, interaction with regulatory agencies before and during the development and review process
Preparation of submission package and filing requirements
Monitoring progress of regulatory review
Assessing proposed manufacturing changes on preclinical and clinical development and regulatory submission strategies
Regulatory agencies queries and actions
Premarket regulatory reporting requirements

Postmarketing

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

General Tasks	Pharmaceuticals/ Biologics/ Medicinal Products	Medical Devices, IVDs
	Product Types
Compliance requirements of advertising and promotion materials
Labeling requirements and compliance measures
Notifiable change submissions and product update reporting requirements
SOPs to manage product associated events, complaints, recalls, marketing withdrawals, vigilance reports
Information for risk management & regulatory options for risk mitigation
Regulatory strategy and specific approaches for handling recalls
Notifiable changes and reporting requirements
Reporting product safety issues
Submission of safety reports
Postmarket surveillance requirements
Change control evaluation and reporting requirements
Regulatory considerations and impacts related to crisis management
Regulatory aspects related to contracts for manufacturing and distribution
Access to regulatory documentation, confidentiality and protection of proprietary information
Maintaining licenses
Patent/trademark forms and reporting to regulatory authorities
Quality system requirements for medical devices
Import/export requirements
Compliance with applicable market controls
Product traceability systems

Interfacing

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

General Tasks	Pharmaceuticals/ Biologics/ Medicinal Products	Medical Devices, IVDs
	Product Types
Working with inspection and audit teams
Communicating with regulatory authorities and stakeholders
Preparing presentations to and meeting with regulatory/government agencies, advisory committees
Providing input on proposed legislation
Advising stakeholders on regulatory impact of proposed legislation, regulation and standards
Role of industry/trade, standards and professional organizations on regulatory process and legislation development
Maintaining regulatory, legislative, standards and related information to support strategic planning and compliance
Reviewing public communications, press releases, etc. to ensure regulatory compliance
Review and communicate about acceptability of claims and other regulatory matters related to product sales
Communicating with organization personnel on issues with regulatory bodies
Participating on internal product review committees
Early warning systems and their internal use for addressing potential compliance issues

RAC Self-Assessment Tool

Strategic Planning

Premarketing

Postmarketing

Interfacing

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