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