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Intellectual Property, often abbreviated to IP, plays an extremely significant role in the generic world, but not everybody who ought to know about it really understands it. Important matters such as patent issues and data exclusivity are often confused, even though there are significant differences between them.

Benefits of attending:

  • GAIN an understanding of how IP affects commercial aspects of the generics business
  • APPRECIATE how IP also affects regulatory aspects of the generics business
  • INSIGHT into the complicated issue of data exclusivity
  • DISCUSS the topic with fellow professionals in your field and exchange experiences.

This Master Class will help you to navigate the complicated landscape of intellectual property and generics. IP issues can affect generic development, registration and launch and making mistakes due to a lack of knowledge can work out very expensive. Generic companies are also increasingly aggressive in their use of patents against each other to gain advantages, which has led to generic wars.

Anyone who wants to make progress in the generic world needs to ensure that they have a good understanding of the basic issues, which this half day seminar is designed to provide.

Feedback from last year's event

“Well presented & clear”
“I enjoyed the master class and learned quite a lot"

This year's master class programme has been thoroughly revised and updated to include a new focus on how generic companies are increasingly using patents to gain advantages over each other and how this has lead to generic wars.

About your Master Class Leader

Peter Wittner, B.Sc., is an independent consultant specialising in the commercial and legal aspects of generics with more than 30 years' pharmaceutical experience. Before starting his own business, Peter was responsible for European generic sales at Evans Medical and later headed the European sales and marketing department of the UK generics company H.N. Norton, which subsequently became part of IVAX.

He later joined the Indian generic leader Ranbaxy as Managing Director to help set up its UK business and then returned to consultancy work. Interpharm advises new market entrants on generic strategies, works with companies that are seeking to enlarge their product portfolios, provides support in business development for generic companies based outside the EU that are trying to enter the market and acts as an agent for a CRO providing biostudies to the generic industry. On the other side of the equation, Interpharm has also worked with originator companies that are looking at ways of defending their major brands from generic incursion.

In addition, Peter is a regular speaker at generic conferences and conducts training seminars on behalf of Management Forum. He has written a number of reports on generics industry topics including “Growth Strategies in Generics”, “Generics Defense Strategies” and “US and European Prescription Generic Markets” as well as a series of reports for Decision Resources including one published in 2008 on Indian Generics. Peter is also a regular contributor to the GenericsWeb newsletter “INNsight”.
 

About the Organisation

Interpharm Consultancy specialises in offering support to the generic industry, particularly companies that are new to the field or based outside Europe. Peter Wittner set up the company in 1998 after leaving Ranbaxy with the intention of sharing his experience of the generic industry at both the national and international level.

Interpharm has cooperated with a number of generic companies to help them work out their strategy for expansion, but also with branded companies concerned about the potential impact of generics on certain of their brands that are nearing the end of the patent protection period.

Apart from giving assistance with market development and growth strategies, Interpharm works with companies looking to buy in new generic products to expand their portfolio and uses its connections with the major European generic groups to introduce overseas manufacturers to potential new business partners and markets.  Interpharm can also provide on-site training on strategic, legal and regulatory issues affecting the generics industry. www.interpharm-consultancy.co.uk
 

Masterclass programme

8:30 Registration & Coffee

9:00 Welcome and Introduction

9:10 Overview - What is IP?

10:00 Patent Types and their impact on generics – How generic companies use IP

11:00 Morning Coffee

11:20 Data exclusivity and its impact on generics

12:10 Discussion, questions and problems from the audience

12:30 Close of Masterclass

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WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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