Understanding the Pharmaceutical Industry

Course overview

Understanding the dynamics and drivers of the industry you work in is key to understanding how and why key decisions are made within your organisation.

In turn, this enables you to appreciate your potential impact on the overall success of the organisation. With this in mind, Falconbury have developed this concise distance learning course which delivers a complete insider's guide to the pharmaceutical industry; it's history and background, the process of discovery, clinical trials, taking the drug to market; the challenges and opportunities facing the industry now and in the future.

If you are new to the industry, or are in a support role or otherwise would like to broaden your understanding of the environment in which you work, then this 6 module course is essential for your development.

How does this distance learning programme work and what do you get?

• Six modules, each requiring between 3 to 4 hours study to be completed as you choose
• The course and its modules start at any time to suit you
• Modules may be downloaded to study on your PC or to print hard copies. (You may also opt to receive them printed-and-bound from us.)
• Each module has self-assessment progress questions and model answers
• The course has an optional on-line multiple choice assessment at the end, with a certificate of completion being awarded

Who should take this course?

Anyone working within the industry who is new to it or who would like to broaden their understanding of the pharmaceutical industry and who works in any of the following functions:

• R & D: all areas of drug discovery and development, including clinical, and regulatory affairs
• Production and quality assurance
• Marketing and sales
• Business development and licensing
• Finance
• Legal
• Human resources
• Administrative support

This course will:

• PROVIDE a review of the dynamics and drivers of the industry
• OUTLINE the drug development process, including pre-clinical activities
• DEFINE the key challenges faced in registering a drug
• FOCUS on the function and importance of alliances and deals
• ENABLE you to get-to-grips with the journey through each clinical trial phase
• EXPLAIN the particular marketing and selling strategies, tactics and techniques employed in the pharmaceutical industry
• EXAMINE the current and future trends and their implications across the sector

Course modules

MODULE 1 – INTRODUCTION TO THE PRESCRIPTION PHARMA INDUSTRY

• The structure of the pharmaceutical industry; international importance
• A brief history
• Medicines classification
• How the nature of disease and drug treatment relates to industry therapeutic areas
• Mission statements and therapeutic goals
• What is distinctive about the pharmaceutical industry?
• The importance of intellectual property rights

MODULE 2 – DRUG DISCOVERY AND PRE-CLINICAL ACTIVITIES

• The target product profile
• Key milestones in the development process
• Drug synthesis and selection; safety; animal pharmacology; ADMET
• Biotechnology/start-ups – differences between biotech and pharma companies
• Contract research organisations
• Enabling technologies

MODULE 3 – FROM CLINICAL TRIALS TO REGISTRATION

• GCP
• Data management and statistics
• Clinical trials by phase
• Attrition rates
• Pharmaceutical development
• Manufacturing (including GMP)
• Quality control/assurance
• Drug registration
• Orphan drugs

MODULE 4 – BUSINESS DEVELOPMENT

• The function of business development
• The importance of strategic alliances
• Mergers and acquisitions

MODULE 5 – HOW DRUGS ARE MARKETED AND SOLD

• Pharmaceutical market research
• Marketing strategies
• Promotional activities – the sales force and advertising
• Pricing
• Distribution
• Parallel trade
• Who's who in the marketing department

MODULE 6 – CURRENT AND FUTURE TRENDS

• Emerging geographical markets
• US vs Europe
• Product life-cycle management (including Phase IV development)
• Strategy for new therapeutic markets
• Barriers to future entry
• Diversification away from pharmaceuticals