Content and Curriculum

MODULE 1

Introduction to Medical Affairs and Medicines Development – The role of  medical affairs in a changing world

The drug development process

• Product life cycle
  • The discovery process and non – clinical development
  • Principles of toxicology and toxicokinetics
  • Principles of genomics and pharmacogenetics: personalized medicine
• Disease models and target identification
• Clinical and Translational research and basic biostatistics:
  • Principles of translational research: from bench to bedside
  • Biomarkers and surrogate endpoints in clinical research
  • Experimental design and basic biostatistics
• Clinical research
  • Ethics
  • GCP
  • Hierarchy of CTs (phases of CTs with special emphasis on Phase III and Phase IV)
  • Data capture/handling
  • Role of local management vs. corporate processes
  • Protocol development (phase IV and investigator – initiated trials)
  • Analysis
  • Reporting
  • Publication
  • Use of data for commercialisation
  • Issue management
  • DOs and DONTs in clinical research

Learning outcomes Module 1

• Outline the steps in the pharmaceutical development of a drug substance and the final product
• 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
• Analyze and compare the principles and applications of statistics in clinical trials
• Describe the principles and operational aspects related to intellectual property, patents and
• Summarize the key documents related to the ethical conduct of clinical trials
• Outline the Investigators Brochure sections and describe its use, approval and
• Revise the principles and practical relevance of ethical issues in biomedical research and the legal and ethicalprovision for the protection of clinical trial subjects.
• Identify the key issues involved in the conduct of a clinical study including investigator and site selection, sitemanagement and conflict
• Describe the procedures for clinical trial data collection and data management to ensure optimal quality dataand outline the various quality management issues in clinical
• 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 governance committees during the study conduct
• Discuss the evaluation and interpretation of clinical trials results

MODULE 2

Medical Approval of marketing and sales material, sponsoring activities, medical eventsusing international standards

• Principles and practice of marketing
  • The role of Medical Affairs
• Advertising and promotion and promotional review
  • The development of promotional materials before review
  • Regulations and Codes of Practice
  • Good promotional practices
  • Review Committees
• The MSL function
  • The need for MSLs in a changing global landscape
  • Roles and responsibilities, education and training
  • Different customers and alignment across channels
  • Scientific exchange and insight analysis concepts
• Medical Multi-Channel Communication
  • Strategy
  • Implementation
  • Management
• Standards
  • International standards
  • Relations to FDA standards
  • Internal standards and compliance rules
  • Local standards GCC countries
  • Organisational recommendations/ archiving/ issue management
• Business case and practical examples
• DOs and DONTs and issue management in medical approval

Learning outcomes Module 2

• 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, ) to asuccessful 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
• Discuss the role of generics and biosimilars

MODULE 3

Creating a high – performance organization in Medical Affairs and Medicines Development

• Public and Professional Relations
  • Role of Patient and Patient Organizations
  • Professional Associations and academic institutions
  • Key Opinion leaders contacts and relations
  • Government relations
  • Communication strategies
  • The basics of adult education and continuing professional development, Accreditation, Certification
  • Conflicts of interest: academia, professional associations and industry
  • Medical Education within pharmaceuticals 
• Management Issues in Medical Affairs
  • RWE
  • Crisis management
  • Controlled medicines
  • Drug abuse and dependence
  • Patent protection and price management

Learning outcomes Module 3

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