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With evidence suggesting that there are no direct benefits to patients through the application of parallel trade, is it time that policymakers re-evaluated current practices to protect the pharmaceutical industry? SMi’s conference ‘Parallel Trade’ will seek to uncover the true impact on drug manufacturers, patients and research and development. Discussing safety, regulatory policy, intellectual property and packaging, hear key leaders in the field provide advice on how to strategically combat this growing problem. Through case studies and plenary lectures, listen to aspects of parallel trade with a focus on pricing & reimbursement and wholesale & distribution.

Hear cutting edge contributions from leaders in the field, including:

  • Dr Thomas Zimmer, Corporate Senior Vice President, CD Safety, Quality and Environmental Protection, Boehringer-Ingelheim
  • Neil Palmer, Vice President, Pricing and Reimbursement, RTI Health Solutions
  • Kipp Snider, Director, State Government Affairs, Global Government Affairs, Amgen
  • Eric Noehrenberg, Director, International Trade and Market Policy, International Federation of Pharmaceutical Manufacturers Associations (IFPMA)
  • Stefan Rinn, Head, Corporate Division, Prescriptions Medicines, Europe, Boehringer-Ingelheim
  • Huda Midani, Vice President, Business Development, Healthcare & Life Sciences, Authentix
  • Bruce Dudzik, Senior Director, Business Development, NanoInk
  • Donald Macarthur, Senior Consultant, PriceSpective & Former Secretary General, European Association of Euro-Pharmaceutical Companies
  • Boris Simovich, President, Light Management Consulting

Key issues that will be addressed at the conference include:

  • The Effect of Parallel Trade: Hear global perspectives about the economic and socialistic impacts of parallel trade on patients, pharmaceutical manufacturers and traders in the EU and US
  • Pricing and Reimbursement: Learn about the true impact of parallel trade and discover if the concept of a single market can ever be a reality
  • Wholesale and Distribution: Hear how parallel trade has and will affect cross border trade and the pharmaceutical supply chain and practical considerations to overcome it
  • Regulatory Affairs and Intellectual Property: Discuss effective strategies to overcome the challenges facing the industry and gain the knowledge of how to ensure product compliance
  • Pharmaceutical Packaging and Tracking: Strategies and tactics to ensure product safety, brand integrity and consumer confidence
  • Networking Opportunities: Meet the key leaders in the field, make valuable contacts and learn from their experience and expertise

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Boris Simkovich

Boris Simkovich, President, Light Management Consulting LLC

9:10 KEYNOTE ADDRESS

Boris Simkovich

Boris Simkovich, President, Light Management Consulting LLC

·                How has industry’s strategy vis-à-vis parallel trade evolved over time?
·                What strategies have fallen in – and out – of favour?
·                What forces have influenced the evolution of industry strategy?
·                What is the outlook for the future?

9:50 PARALLEL TRADE: DEBUNKING SOME COMMON MYTHS

Donald Macarthur

Donald Macarthur, Senior Consultant, PriceSpective

·                The EU gives the trade unqualified support
·                It's best left to our legal department to manage
·                Pharmacists dispense parallel trade at every opportunity
·                Now the "common origin" criterion for regulatory approval is gone our brands will have to compete with parallel-imported generics
·                Every time the EU enlarges the situation gets worse
·                High prices mean parallel importation into the US is inevitable

10:30 Morning Coffee

11:00 HOW PREDICTABLE IS PARALLEL TRADE?

Gary Johnson

Gary Johnson, Managing Director, Inpharmation Ltd

·                What do people think are the key drivers of parallel trade?
·                What are the actual key drivers?
·                What is system dynamics and why is it the preferred route for PI forecasting?
·                How can you validate a PI forecasting methodology when you cannot observe all the flows?

11:40 DOES PARALLEL TRADE BENEFIT THE PATIENT?

Eric Noehrenberg

Eric Noehrenberg, Director, International Trade and Market Policy, International Federation Of Pharmaceutical Manufacturers Association (I F P M A)

·                Does parallel trade benefit the poor?
·                Parallel trade and counterfeit products
·                Product diversion and access programmes

12:20 Networking Lunch

13:50 PARALLEL TRADE

Stefan Rinn

Stefan Rinn, Head, Corporate Division, Prescription Medicines Europe, Boehringer Ingelheim GmbH

·                Losses of margins
·                Trends in distribution models
·                Legal measures to deal with parallel trade issues

14:30 PHARMACEUTICAL PACKAGING AND TRACKING

Andre Grigjanis

Andre Grigjanis, Managing Director, GCC Pharma

·                Repackaging issues
-       Issues in counterfeiting
-          Affect on safety and quality
-          Tagging (RFID/2D Barcode)
-       Considering standards
·                The importance of drug tracking throughout the pharma supply chain
·                Existing and planned pharma tracking regulations
·                Retaining brand integrity and consumer confidence through packaging
·                Overcoming pitfalls - from consumer clarity to label compliance

15:10 Afternoon Tea

15:40 DRUG TRACKING

Huda Midani

Huda Midani, Vice President, Business Development, Authentix

·                The FDA guidance issued on June 9th 2006
·                The benefits of tracking drugs on patient safety
·                Is there a role for drug tracking in a parallel trade environment?
·                Present and future drug tracking solutions
·                How does drug tracking secure brand integrity to regain consumers' confidence with the healthcare industry?

16:20 REGULATORY ISSUES AND INTELLECTUAL PROPERTY RIGHTS

·                How the European courts are shaping the law on parallel trade

·                Gaining and withdrawing market authorisations

·                Eurogenerics - is there still a difference between generics and parallel imports?

·                Invoking trade mark rights - the state of play

·                Invoking patent rights - the exhaustion of rights rules and the Accession Treaty

·                Withdrawal of reference products and competition law - is the EU importing US rules?

Maarten Meulenbelt

Maarten Meulenbelt, Partner, NautaDutilh

Maarten Meulenbelt

Maarten Meulenbelt, Partner, Howrey LLP

17:00 Chairman’s Closing Remarks and Close of Day One

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Thomas Zimmer

Thomas Zimmer, Corporate Senior Vice President, CD Safety, Quality & Environmental Protection, Boehringer-Ingelheim

9:10 PARALLEL TRADE AND SUPPLY CHAIN TRANSPARENCY

Thomas Zimmer

Thomas Zimmer, Corporate Senior Vice President, CD Safety, Quality & Environmental Protection, Boehringer-Ingelheim

·                Consequences for counterfeit penetration
·                GMP issues
·                Recall and complaint management

9:50 CROSS BORDER TRADE

Peter Laurence

Peter Laurence, Director, scb consulting

·                Manufacturer’s channel partners – friend or foe?
·                Supply chain security – is the manufacturer in control?
·                Practical considerations in monitoring cross border flows
·                Minimising the impact of cross border flows on the quality of the demand plan
·                Cross border trade – an easy win for sales management?

10:30 Morning Coffee

11:00 THE IMPACT OF STATE AND FEDERAL GOVERNMENTS IN THE U.S.

Kipp Snider

Kipp Snider, Director, Amgen

  • Overview of state and federal government roles
  • State government basics
  • Medicare and Medicaid programs
  • Current public and political environments
  • The importation debate
  • The future and protecting innovation

11:40 PROSPECTS FOR PARALLEL TRADE IN NORTH AMERICA

Neil Palmer

Neil Palmer, Vice President, RTI Health Solutions

·                Overview of parallel trade in North America
·                Status of legislative initiatives to allow importation and re-importation
·                Understanding how parallel trade in North America would differ from Europe
·                Impact of Medicare Part D on North American parallel trade
·                Trends in Canada and US internet pharmacy sales
·                Factors affecting growth and decline in internet pharmacy
·                Outlook and implications for parallel trade in North America

12:20 Networking Lunch

13:50 PATIENTS INGEST PHARMACEUTICAL TABLETS, NOT BOTTLE LABELS

Bruce Dudzik

Bruce Dudzik, Senior Director , Nanoink

·                Protecting and authenticating the package alone does not certify authentic content
·                Counterfeiter, diverters and legitimate wholesalers switch units and repackage pharmaceutical drugs
·                Unit dosage level protection and authentication is necessary to really ensure patients are getting the right medication
·                Unit dosage level encryption with encrypted batch level data will combat illegal diversion
·                Individual tablet encryptions can house data such as where the product was made, when it was made and where it is to be  shipped to

14:30 CHANGING THE BIO-PHARMACEUTICAL DISTRIBUTION MODEL

Rolf Fricker

Rolf Fricker, Senior Executive Advisor, Booz Allen Hamilton

·                Parallel trade as threat to industry and patients alike
·                Development of pan-European wholesalers and impact on pharmaceutical distribution in Europe
·                Direct-to-Pharmacy distribution as a way to increase supply chain visibility and control
·                Implementing DTP models, Lessons learned
·                The global picture and limitations of DTP strategies

15:10 CONCEPT OF A SINGLE MARKET

Jim Furniss

Jim Furniss, Director, Pricing & Reimbursement, Bridgehead International

·                Considering the pharmaceutical markets for individual countries and the EU as a single state
·                How feasible is a single market, EU or global?
·                Why wouldn’t a single market work?

16:20 Chairman’s Closing Remarks followed by Afternoon Tea and Close of Conference

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Workshops

How to React to Parallel Trade (PM)
Workshop

How to React to Parallel Trade (PM)

The Hatton, at etc. venues
13th February 2007
London, United Kingdom

To Understand Parallel Trade, You Have to Understand Parallel Traders (AM)
Workshop

To Understand Parallel Trade, You Have to Understand Parallel Traders (AM)

The Hatton, at etc. venues
16th February 2007
London, United Kingdom

Cross Border Trade & the Pharmaceutical Manufacturer (PM)
Workshop

Cross Border Trade & the Pharmaceutical Manufacturer (PM)

The Hatton, at etc. venues
16th February 2007
London, United Kingdom

The Hatton, at etc. venues

51/53 Hatton Garden
London EC1N 8HN
United Kingdom

The Hatton, at etc. venues

HOTEL BOOKING FORM

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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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