The IFAPP-Kings College Medical Affairs in Medicines Development Certification Program
Learning Outcomes

List of Modules:

  1. Introduction to Medical Affairs in Medicines Development
  2. Medical Affairs and Health Economics
  3. Drug Discovery, Exploratory and Confirmatory Development
  4. Clinical trials: from concept to study report
  5. Regulatory Affairs, Drug Safety and Pharmacovigilance
  6. Medical Affairs as a Strategic Business Partner: Adding Value, Accelerating Performance, and Increasing Relevance

Module I: Introduction to Medical Affairs in Medicines Development

On successful completion of this module, the student should be able to:

  • Justify the emerging relevance of the Medical Affairs functions as an effective interface with external stakeholders to ensure the right medicines are available for patient access and proper use.
  • Describe the process of drug development based upon a target product profile (TPP) and identify the critical factors and decision points to meet expectations of customers and stakeholders
  • Describe the principles  of clinical pharmacology and the  practical applications of pharmacokinetics and pharmacodynamics
  • Describe the molecular and cellular basis of adverse and toxic reactions and influence of genetic factors in drug development and drug response
  • Describe the principles of translational research and application of statistics in medicines development
  • Conclude the importance of the patient in drug development
  • Discuss the background to the development of medicines regulation and the role of the competent authorities
  • Outline the principles of drug safety and risk management
  • Justify the principles of medical-marketing and health economics

Module II: Medical Affairs and Health Economics

On successful completion of this module, the student should be able to:

  • Summarize the principles of medical/marketing and the role of Medical Affairs
  • Understand the processes of development and review of product information to ensure compliance to ethical, legal and regulatory principles pertaining to Good Promotional Practices and marketing activities
  • Appraise the contributions of the various medical affairs related functions (medical information, medical communication and education, medical service liaisons, external affairs, strategic alliances, etc) to a successful business conduct within the organization
  • Critically appreciate a Multi-Channel Communication strategy
  • Understand the role of Medical Affairs in the life-cycle management of medicines (with clinical, regulatory and marketing), different types of data generation and the role of the medical affairs function
  • Outline the principles and practical applications of health economics and patient reported outcomes, Health Technology
  • Assessment and value generation and communication
  • Discuss the role of generics and biosimilars

Module III: Drug Discovery, Exploratory and Confirmatory Development

On successful completion of this module, the student should be able to:

  • Appraise the choice and predictive value of the non-clinical testing program as part the overall drug development plan
  • Outline the steps in the pharmaceutical development of a drug substance and the final product (including chemical and biological compounds)
  • Describe the planning of clinical trial supplies (active or placebo)
  • Outline the design of clinical trials, including legal, regulatory, ethical and practical aspects
  • Describe the influence of genetic factors in drug development and drug response
  • Outline the exploratory development program: dose-finding/proof of concept studies and their impact on the overall drug development plan
  • Outline the key operational and strategic issues in the Confirmatory Development Plan
  • Analyze and compare the principles and applications of statistics in clinical trials
  • Understand the importance of study design for conducting clinical trials
  • Communicate meaningfully with statisticians in project teams to ensure the aims of a trial are met
  • Understand the key statistical issues when reading journal papers
  • Outline the strategy for lifecycle management of drugs and the relevance of evaluating real-world evidence

Module IV: Clinical Trials – From Concept to Clinical Study Report

On successful completion of this module, the student should be able to:

  • Summarize the key documents related to the ethical conduct of clinical trials
  • Outline the Investigators Brochure sections and describe its use, approval, and distribution.
  • Revise the principles and practical relevance of ethical issues in biomedical research and the legal and ethical provision for the protection of clinical trial subjects.
  • Identify the key issues involved in the conduct of a clinical study including investigator and site selection, site management and conflict resolution.
  • Describe the procedures for clinical trial data collection and data management to ensure optimal quality data and outline the various quality management issues in clinical trials.
  • Outline a study level feasibility plan and describe the structure of a study budget.
  • Outline the various quality management issues in clinical trials
  • Discuss the collection, evaluation, and reporting of adverse event data in clinical trials
  • Explain the role of the DSMB and other governance committees during the study conduct
  • Discuss the evaluation and interpretation of clinical trials results

Module V: Regulatory Affairs, Drug Safety and Pharmacovigilance

On successful completion of this module, the student should be able to:

  • Categorize the general principles of medicines and device regulation as well as the regulatory process in the USA, Europe and the rest of the world.
  • Compare the role of national agencies and international bodies, such as the International Conference on Harmonization in medicines regulation.
  • Justify the impact of medicines legislative requirements on regulatory activities within a pharmaceutical company and its impact in planning and reviewing the product strategy.
  • Compare and contrast medical device regulation and drug regulations.
  • Value the role of pharmacoepidemiology and risk management in the lifecycle management of a medicine.
  • Appraise adverse events/adverse drug reactions in terms of severity and then describe the safety reporting requirements pre and post-approval.
  • Calculate and interpret measures of risk.
  • Evaluate the ongoing management of drug safety issues pre and post-approval (including risk management plans, periodic safety update reports, and post-authorization safety studies) and the ongoing benefit/risk assessment throughout the lifecycle of a medicine.
  • Evaluate the factors influencing medication safety from the perspective of each stakeholder.
  • Devise a global regulatory strategy to maximize the probability of successfully gaining regulatory agency approval of a new pharmaceutical.
  • Explain the conditions for involving patients in medicines development.

Module VI: Medical Affairs as a Strategic Business Partner: Adding Value, Accelerating Performance, and Increasing Relevance

On successful completion of this module, the student should be able to:

  • Integrate principles and practices of people management and leadership, to apply within their own work environment
  • Describe the principles of professionalism, assessment of competence, and identity formation to guide the practice of medical affairs in medicines development
  • Describe the ethical issues and ongoing tensions between the need for financial incentives for clinical research and medicines development and the global need for affordable medicines
  • Apply ethical behavioral framework needed for working in multidisciplinary clinical research or therapeutic teams
  • Discuss the role of patients and professional organizations in health care
  • Appraise contributions of medical affairs related functions to successful business conduct within the organization
  • Compare processes of production and review of product information to ensure compliance with ethical, legal, and regulatory principles
  • Ensure various functions within the organization are aligned to achieve the business and professional goals
  • Describe principles and processes needed to develop an effective medical strategic/business plan
  • Outline the value of networks and strategic alliances to meet business objectives
  • Describe quality and project management tools, as well as performance improvement concepts, to address organizational performance