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Certified National Pharmaceutical Representative

GES 106 -- 120 hours

Course Outline

• Introduction
  1. The pharmaceutical industry
  2. Why is there growth?
  3. Technology
  4. Healthcare Demand
  5. Food and Drug Administration
  6. Pharmaceutical Marketing
  7. Geography of pharmaceutical sales
  8. Various job descriptions
  9. Compensation
• A day in the life of a pharmaceutical representative
  1. Marketing products to physicians
  2. Time Management
  3. Continuing product education
  4. Path to additional educational material
• The Research and Development Process
  1. Growing need for more complex data and research
  2. Policy implications
  3. The impact of higher R & D costs
  4. Dynamic Growth
  5. Pharmaceutical Research Spending
  6. Benefits of government-industry partnerships
  7. Value of pharmaceutical marketing
  8. Why US R & D has increased
  9. Increased scientific opportunities
• New medicines mean strength for U.S. economy
  1. Pharmaceutical R & D Boost the U.S. economy
  2. Impact on R & D
  3. Research and Development Terminology
• The anatomy and clinical pharmacology
  1. The cell
  2. Classes of Nutrients
  3. The body's major systems
  4. Basic clinical pharmacology
  5. Main routes of drug administration and drug delivery
  6. Terms & Abbreviations
• Package Insert Information
  1. Description
  2. Clinical Pharmacology
  3. Indications and usage
  4. Contraindications
  5. Warning/Cautions
  6. Adverse Reactions
  7. Drug abuse and dependence
  8. Overdosage
  9. Dosage and administration
  10. How supplied
• Drug Distribution-Supply Chain
  1. Wholesalers - Distributors
  2. Wholesaler's role
  3. Largest Drug Wholesalers
  4. Distribution terminology
• Drug Patents
  1. What is a patent?
  2. How long is a patent granted for?
  3. Difference between patent and exclusivity
  4. How long is exclusivity?
  5. Generic Drugs
  6. FDA's criteria for equivalence
  7. The FDA's Orange Book
  8. Orange Book rating
  9. Single Source Drug products
  10. Multi-Source Drug products
  11. ANDA for generic vs. patent infringement
  12. Generic drug first-to-file exclusivity
  13. Hatch-Waxman Act
  14. Drug Patent terminology
• Drug Sampling
  1. Drug sample storage techniques
  2. Federal regulations
  3. Storage of pharmaceutical products
  4. Recalls on drug products
• Drug Development and Preclinical Studies
  1. Pharmacodynamics
  2. Pharmacokinetics
  3. Transport Mechanism
  4. Absorption
  5. Distribution
  6. Toxicology
  7. Animal Texts, In Vitro Assays, and In Silico Methods
• Clinical Trials
  1. Definition of Clinical Trial
  2. Ethical Considerations
  3. Clinical Trials
  4. Regulatory Requirements
• Drug Discovery
  1. Vaccines
  2. Recent Vaccine Research and Clinical Activities
  3. Human Immune System
  4. Cytokines
  5. Hormones
  6. Gene Therapy
  7. Gene Therapy Trials
  8. Stem Cells
  9. Bone Marrow Transplant
  10. FDA Approval Process Time Frame
• Brand Medicine
  1. Branding in the Pharmaceutical Industry
  2. Brand Medicine
  3. Why Branding is Important
  4. Building Brand Values
  5. Building Brand Strategy
  6. Brand Positioning
  7. Brand Personality
  8. Brand Values
  9. Pharmaceutical Brand Name Development
• Clinical Development and Pharmaceutical Marketing
  1. Healthcare Environment and Trends
  2. Clinical Development and Branding
  3. Branding Values and Vocabulary
  4. Direct-to-consumer Branding – The US perspective
  5. The Growth of Managed Care
  6. Acronyms
• Managed care
  1. Managed care formulary
  2. Drug utilization review
  3. Pharmacy benefit manager
  4. Managed care concepts
  5. Drug formularies and policies
  6. Medicare/Medicaid reimbursement
• Ethical Regulatory Guidelines
  1. AMA Guidelines on gifts to physicians
  2. Background
  3. PhRMA Code on Interactions
• Pharmaceutical selling skills
  1. Getting in to see the physician
  2. Preparing for the sales call
  3. Finding information
  4. Information gathering
  5. Building a relationship
  6. Enhancing the client-rep relationship
  7. Territory planning
  8. Medical office calls
  9. Making the medical office call
  10. Local exhibits and displays
  11. Exhibit fundamentals
  12. Building a relationship with your district manager
  13. Traits of pharmaceutical sales superstars
  14. Hospital calls
• Pharmaceutical Terms, Abbreviations and Meanings
• Therapeutic Classes and Categories