IFAPP Academy:

Competencies refer to the “observable ability of a health professional integrating knowledge, skills, values, and attitudes” to perform effectively.  Competencies are the ingredients of Competence.  A competent professional is the one possessing the required abilities (competencies) in all domains in a certain context at a defined stage of education or practice. – Frontiers in Pharmacology, Oct 2016

IFAPP and PharmaTrain developed a basic set of 7 domains, 57 competencies, and a Statement of Competence.  The competencies are aligned with the learning outcomes of the IFAPP – King’s College London program.  A standard for competency-based education was established and can now be used for certification.

How does IFAPP align with the McKinsey & Co report on the core capabilities of a medical affairs professional?

McKinsey &Co Core Capabilites in Medical Affairs

IFAPP Statement of Competence in Medicines Development

Scientific and technological leadership and strategic visionCan identify unmet therapeutic needs, evaluate the evidence for a new candidate for clinical development and design a Clinical Development Plan for a Target Product Profile.
Scientific and technological leadershipCan design, execute and evaluate exploratory and confirmatory clinical trials and prepare manuscripts or reports for publication and regulatory submissions.
Learning agilityCan interpret effectively the regulatory requirements for the clinical development of a new drug through the product life-cycle to ensure its appropriate therapeutic use and proper risk management.
Deep understanding of complianceCan evaluate the choice, application and analysis of post-authorization surveillance methods to meet the requirements of national/international agencies for proper information and risk minimization to patients and clinical trial subjects.
Strategic vision & scientific leadershipCan combine the principles of clinical research and business ethics for the conduct of clinical trials and commercial operations within the organization.
Deep understanding of complianceCan appraise the pharmaceutical business activities in the healthcare environment to ensure that they remain appropriate, ethical and legal to keep the welfare of patients and subjects at the forefront of decision making in the promotion of medicines and design of clinical trials.
Emotional intelligence and communication skillsEmotional intelligence and communication skills

The competency profile of professionals involved in Medical Affairs and Pharmaceutical Medicine might be comparable. IFAPP and PharmaTrain have developed competency-based educational programs aimed to meet the cognitive aspects of the core competencies.  A strategic cooperation between IFAPP (through the IFAPP Academy) and King’s College London was established to provide education and professional certification in Medical Affairs in Medicines Development with the sponsorship of 4 major pharmaceutical companies.