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Market, legal and regulatory aspects

A one-day seminar to be conducted at your offices
Topics to be covered include:
Understanding the European Generic marketplace
Patents and how they affect generics
Data Exclusivity
DCP and European Regulatory System
Key aspects of European legislation
Peter Wittner, Interpharm Consultancy, London

It is often difficult for those involved in marketing generic medicines to understand the
complicated legal and regulatory environment in which EU generic companies operate.
Similarly, regulatory people themselves are often unsure how the legal and Intellectual
Property framework can influence their own work.
The aim of this seminar is to shed some light on the commercial and legal background to the European generic industry and to provide an understanding of how it affects all parts of the business. Misunderstanding the various factors that influence the time and speed of registration can lead to regulatory delays with a knock-on effect on launch dates for new products. This can, in turn, lead to undesirable commercial delays, which might have an impact on a company’s competitive position.
Attending this seminar will give you:-
• An overview of the generic market, the major players and how the market works • A better understanding of the new Directive 2004/27/EC and the changes that it has introduced to marketing generics in Europe • An overview of IP issues and their importance to the generics industry • An opportunity to gain an appreciation of how European legal and IP issues affect • Awareness of the potential impact of the legislation on the commercial side of the • A clearer insight into and how the regulatory side does not exist in isolation from the commercial side but has a direct impact on it and the interplay between the two areas • A brief look at how the US environment differs from Europe Page 1 of 3
 Marketing and sales personnel looking at European opportunities who want a better  Regulatory personnel who want to have a better understanding of commercial aspects  Production personnel manufacturing products for the European markets Directors of non-European generic companies who want to understand how the  Branded companies that want to obtain a better understanding of how the generic  Anyone involved with European business COMMENTS FROM PREVIOUS PARTICIPANTS
“Interesting, informative and enjoyable.”
“Very comprehensive overview of this area”
Peter Wittner
has been in the pharmaceutical industry for 30 years of which the second half
has been mainly in the area of generics. He worked for the former Evans Medical and then
Norton Pharmaceuticals (now part of IVAX) where he was responsible for European Sales &
Marketing. After leaving Norton, Peter set up his own consultancy in 1993 and operated
independently until 1996 when he joined the Indian company Ranbaxy to set up the
infrastructure of their new UK subsidiary. After spending two years with them, he returned to
his consultancy work and has spent the last 12 years providing consultancy and training
services, specialising in the field of generics
1- Understand the Generic marketplace
How big are the markets in Europe and Worldwide? Increasing industry consolidation – Europe and the US Forthcoming patent expiries and future opportunities How Europeans see the challenge from Asia How generics companies are moving up market 2- Key aspects of European legislation and their implications
Harmonisation of Data Exclusivity – what is 8+2+1? Bolar Clause – what impact will it have? Page 2 of 3
Generic definition and its hidden significance 3- Patents and how they affect generics
Example – Atorvastatin – extensions and disputes 4- Data Exclusivity and its impact on generics
How does it differ from patent exclusivity? 5- The DCP and European Regulatory Systems
For further details and to arrange dates contact:
Page 3 of 3


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