List of Modules:

Introduction to Medical Affairs in Medicines Development
Medical Affairs and Health Economics
Drug Discovery, Exploratory and Confirmatory Development
Clinical trials: from concept to study report
Regulatory Affairs, Drug Safety and Pharmacovigilance
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