OVERVIEW OF THE
GENERICS INDUSTRY

Course Ref: Y01-1000
Fee: £275 + VAT

DISCOUNT AVAILABLE ON REQUEST FOR MULTIPLE LICENCE PURCHASE.  

Generics are attracting an enormous amount of interest around the world and the generic industry is growing strongly. Why?

If you want to understand who are the big players in the industry, how they got there and where the big generics markets are, Management Forum has created an on-line training course. The course is broken down into 6 modules covering all the important topics of markets, competitive environment, players, law, patents and regulations that affect generics.   

THE OVERVIEW OF THE GENERICS INDUSTRY ENABLES STUDENTS TO:-

• Understand what drives the generic industry
• Appreciate which are the most active generic markets and companies
• Identify how individual markets differ from each other
• Learn about the Intellectual Property framework and its relevance to generics
• Avoid confusion when comparing the US and European environments
• See the types of strategies that successful companies have employed

TARGET AUDIENCE

This course is designed to appeal to: -

• Marketing and sales personnel looking at European opportunities
• Regulatory personnel involved with registration in Western countries
• Production personnel manufacturing products for the European markets
• Directors of generic companies in developing markets who want to understand how the European and US generics industries work

Learning outcomes – the course will provide an insight into:

 Generic markets and companies

• Which are the major world generic markets
• Who are the leading companies
• What strategies companies have used to enter the generic market
• What are the criteria for a strong generic market
• Understanding of why price differences exist across markets

Intellectual property

• What types of patents exist
• Patent extensions – comparison of Europe and USA
• How companies challenge patents
• Data exclusivity ~ what it means and its effects

Legal Background

• European Directive 2001/83/EC
• Legislative update 2004/27/EC
• US Hatch-Waxman Act
• Paragraph IV and its importance
• Hatch-Waxman revisions ~ MacCain-Schumer and Gregg-Schumer

Market trends and growth area

• Continuing consolidation admits reason
• New competitors ~ Asia and Latin America
• Pricing pressures and reference pricing
• Future patent expires
• Biosimilars/Biogenerics

Flexible learning

Learners take their own route through the topics covered in the course.  They will learn at their own pace through a variety of activities designed to accommodate a range of learning styles.

Duration:  5 - 6 hours

PLEASE NOTE THERE WILL BE SIX MONTHS ACCESS TO THIS COURSE FROM DATE OF PURCHASE.

FOR THE ANSWERS TO THE 'OVERVIEW OF THE GENERICS INDUSTRY' SAMPLE QUIZ  QUESTIONS PLEASE CLICK HERE