Presented by
Falconbury
Understanding the Pharmaceutical Industry
A 6 MODULE SELF-MANAGED DISTANCE LEARNING COURSE – An insider’s guide to the pharmaceutical industry for anyone new who wants to enhance their knowledge on working in the pharma, bio-tech or life sciences sectors. Gain key skills needed with this 6 module course requiring 3 to 4 hours study each module.
- 8 Modules
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 on-line 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.
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
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:
Take a guided tour
To find out how our unique Learning Management System delivers our on-line training programmes, and how easy to use and interactive they are, click HERE
Certificate of excellence
Participants are invited to undertake a final assessment in the form of an online multiple-choice paper. A pass rate of 80% and above is required to ensure that a high level of competency has been achieved within the subject area, where upon you will receive a ‘Certificate of Excellence’.
The Understanding the Pharmaceutical Industry course will cover:
- MODULE 1 - Introduction to the Prescription Pharmaceutical Industry
- Introduction
- What is distinctive about the pharmaceutical industry?
- The structure of the pharmaceutical industry - and the international dimension
- A short history of the pharmaceutical industry
- The classification of medicines
- The range of pharmaceutical formulations
- Mission statements and therapeutic goals
- Types of intellectual property protection
- Codes of practice
- Self-assessment
- MODULE 2 - Drug Discovery and Development - Part 1
- Introduction
- The target product profile
- The pre-clinical phase
- Chemistry
- Biology
- Pharmaceutical development
- Good laboratory practice
- Manufacturing
- Quality control and assurance
- Clinical trials by phase
- Regulatory approval
- Phase IV clinical trials
- Cost of R&D
- Project management
- Key milestones in the development process
- Enabling technologies
- Contract research organisations
- Self-assessment
- MODULE 3 - Drug Discovery and Development - Part 2
- Portfolio analysis and management
- Attrition rates in drug development
- How industry therapeutic areas relate to the nature of disease and drug treatment
- Statistics - clinical trial design and epidemiology
- Ethics and the pharmaceutical industry
- Orphan drugs
- Biotechnology/start-up companies - how they differ from pharmaceutical companies
- Self-assessment
- MODULE 4 - Commercial Functions - Part 1: Business Development and Pricing
- Business Development
- Introduction
- The function of business development
- The development of strategic alliances
- The range of alliance types
- Contract marketing
- Joint ventures
- Mergers and acquisitions
- Mergers versus strategic alliances
- Pricing
- Introduction
- Global pricing issues
- Pricing mechanisms and reimbursement
- Profit control: the UK pharmaceutical Price Regulation Scheme (PPRS)
- Self-assessment
- Business Development
- MODULE 5 - Commercial Functions - Part 2: Marketing, Sales and Distribution
- Introduction
- Marketing strategy
- Marketing objectives
- Market selection
- Who buys products?
- The role of marketing in pharmaceuticals
- Promotional activities
- Promotion of the company rather than of products
- Product launches
- Principal promotional media
- Marketing research
- Marketing’s function in new product planning
- Product life-cycle management
- The importance of range extensions
- Who’s who in the marketing department
- Distribution
- Self-assessment
- MODULE 6 - Current and Future Trends
- Introduction
- Emerging markets
- US versus Europe - a continuing saga
- Strategies for new therapeutic markets
- The impact of personalised medicine
- Biosimilar products - how much of an opportunity?
- Barriers to entry
- Diversification away from pharmaceuticals
- Self-assessment
- Final Assessment
- Course Evaluation
John Ansell
John Ansell Consultancy
John Ansell is a biochemistry graduate with a Masters degree in Business Studies. John began his 20-year career in international marketing and business development in Holland with Organon, worked for Schering AG and Fisons in the UK, and again in Holland, with Solvay. Finally, from 1985 to 1989 he worked at Glaxo Holdings, on Zantac. Subsequently, as an independent industry consultant, John has worked for over 100 clients on commercial strategic projects. He is a frequent speaker, and has also acted as chairman of over 30 industry conferences. John is the author of more than 40 articles and reports on strategic industry issues.
