Introduction:
The Medical Affairs Professional Society (MAPS) is committed to ensuring that accredited courses are applicable to learners and the course content is reviewed for quality, currency, effectiveness, and applicability. This policy is to establish continuing education offerings of the highest quality to help the learner in his/her Medical Affairs development.
Purpose:
The purpose of this policy is to make certain that MAPS’ continuing education course offerings are of the highest quality, are presented with current and applicable material, and training is effective to help the learner in his/her Medical Affairs’ professional development.
Policy:
To ensure quality curriculum development and conformity to requirements for currency, effectiveness and applicability are met, MAPS aligns and validates the content of our International Accreditors for Continuing Education and Training (IACET) aligned learning activities with the following standards. Specifically,
- MAPS designs, develops, and evaluates each IACET aligned course and learning materials in a thorough instructional design planning process as evidenced by a completed and approved CE Planning, Course Content and Sequencing, and Learning Environment and Accessibility This process, overseen by a Continuing Education/Training (CE/T) Planner and approved by the Director of Learning and Development, ensures sound instructional design is applied based on adult learning theory principles; and content is targeted for a specified audience based on a viable needs analysis.
- All course content recommendations involving clinical medicine, business acumen, leadership, data, and other subject matter related to medical affairs protocol and practices implemented must be evidence-based with adequate support and justifications supplied.
- Course content must be presented without industry (Pharma and Med Device) bias or proprietary information and reflect the industry overall.
- All scientific research referred to, reported, or used in an accredited course must conform to the generally accepted standards of experimental design, data collection and analysis.
- Scientific research and literature used as the major support references in a course and/or to justify the needs analysis and gaps assessment, must include those that represent the most current and accepted research or practice in the field.
- MAPS courses are not eligible for accreditation or provision of credits if they present activities that promote recommendations, treatment, or manners of practicing medical affairs that are known to have risks or dangers that outweigh the benefits or known to be ineffective in the treatment of patients. Courses will not advocate for unscientific modalities of diagnosis, technology, data collection or therapies.
- Courses must include formative and summative assessments to ensure learners are attaining the intended outcomes.
- Through a standardized evaluation form, each accredited course is reviewed immediately following the event to determine the achievement of intended learning outcomes. Subsequently, a course’s content will be modified and/or delivery methods will be adjusted if preliminary evaluations show learner outcomes are not being accomplished (ratings of 2.99 or lower on a 5-point Likert scale).
Responsibilities:
- The Director L & D will:
- Through active promotion of this policy, regularly review the leadership and commitment given to ensuring that the subject matter experts who develop and/or present content are of the highest level.
- Ensure that the organization’s practices and processes incorporate precautions against infractions of policy.
- Monitor performance by way of periodic review of staff reports and evaluations.
- Review, as appropriate, on the effectiveness of the management systems established to ensure compliance with the policy.
- Analyze material breaches and identified compliance system weaknesses for systematic trends and ensure that any adverse trends are addressed.
- Promote a culture of effective policy compliance across the organization.
- All MAPS staff, volunteers, educational content developers/planners and instructors at all levels will:
- Ensure that they are aware of this policy and agree to adherence of this policy.
- Not act in a manner that is contrary to the policy.
- Where appropriate, suggest ways in which practices, systems and procedures could be improved to reduce the likelihood of violation of the content policy occurring.
Processes:Â Â
The Director of L & D will initially review the organization’s procedures in all areas to ensure that these are in accordance with the principles expressed in this policy and will report to the Board of Directors on this matter.
The Director L & D will review any changes to the organization’s procedures in all areas to ensure that these are in accordance with the principles expressed in this policy.
Educational content developers/planners and instructors are made aware of the policy through their Content Participation Agreement, and through a discussion of this and all relevant policies during the kickoff call. Everyone involved in the development of course content and all MAPS staff are required to accept compliance with the policy via the Content Participant Agreement /via email confirmation acknowledgement.
This policy, as well as all other applicable policies, is provided to learners via a link to the policy posted on MAPS website.
MAPS staff are trained on this policy through an email notice and subsequent in-service to discuss adherence.
Non-compliance:
Any notice of non-compliance with the policy will be immediately reviewed by the Continuing Education/Training (CE/T )Planner and Director of L&D. If a content developer/presenter is deemed to not be in compliance with the policy regarding the development, presentation, or learning of a MAPS continuing education offering, s/he will be advised of the infraction, and will be given one opportunity to immediately correct the infraction. If the infraction is not corrected forthwith or if a second violation occurs, the individual will be removed from the program and from any working group or team responsible for content and barred from participating in any current and future MAPS content development and/or presentation.