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Parallel Trade

SAE Media Group’s Parallel Trade conference returns to London for its 12th year on 6th-7th Feb 2018.
Over the years, the European Single market has allowed for pharmaceuticals to be imported and exported freely between member states without the permission of the manufacturers. However, with the arrival of Brexit and guidelines to immanently enforce the Falsified Medicines Directive (FMD) by 2019, the market for pharmaceutical parallel trade is changing.


Join us as we discuss the latest changes to regulation, their implementation and major court cases in intellectual property influencing distribution practices. We will also be exploring the safety of patients in relation to the surge in pharmaceutical E-commerce and ways in which currency fluctuations are likely to disrupt the flow of drugs to certain countries in the EU and beyond.
 

FEATURED SPEAKERS

Darragh O'loughlin

Darragh O'loughlin

Secretary General, Irish Pharmacy Union
Felipe Florez-Arango

Felipe Florez-Arango

Head of Finance, Europe, Shire
Frank  Weissenfeldt

Frank Weissenfeldt

Senior Manager, Supplier Relations, IQVIA
Mikas Rimantas

Mikas Rimantas

Business Development Director, Lexano

Antonio Mendonca Alves

CEO, MD Pharma SA
Antonio Mendonca Alves

Christopher Stothers

Partner, Arnold and Porter
Christopher Stothers

Darragh O'loughlin

Secretary General, Irish Pharmacy Union
Darragh O'loughlin

Fabrizio Gianfrate

Professor of Health Economics, University of Ferrara
Fabrizio Gianfrate

Farasat Bokhari

Senior Lecturer in Economics, UEA, University of East Anglia
Farasat Bokhari

Felipe Florez-Arango

Head of Finance, Europe, Shire
Felipe Florez-Arango

Flemming Wagner

CEO, ABACUS MEDICINE A/S
Flemming  Wagner

CEO and owner since 2006
Supply of original medicines to hospitals and pharmacies in Europe.
Turnover EUR 174 million in 2016
Development and manufacturing of DayDose: “Supplements simplified” – www. daydose.com
7 double Gazelle Award winner for fast growing companies in Denmark.
“1000 companies to inspire Europe” award by LSEG
Reddot international design award for DayDose
+300 employees and subsidiaries in several EU countries
 

Frank Weissenfeldt

Senior Manager, Supplier Relations, IQVIA
Frank  Weissenfeldt

Heinz Kobelt

Director European Affairs, European Association of Euro-Pharmaceutical Companies
Heinz Kobelt

Ian Walker

Chairman , Epilepsy Action
Ian  Walker

Janice Haigh

VP Pricing & Market Access, PAREXEL
Janice Haigh

Jayne Burton

Elected Trustee, Epilepsy Action
Jayne Burton

John Jolley

Managing Director , PharmaConsult Global Ltd
John Jolley

Mikas Rimantas

Business Development Director, Lexano
Mikas Rimantas

Neil Grubert

Independent Market Access Consultant,
Neil  Grubert

Nick Kaye

Superintendent Pharmacist , S.Kaye & Son Ltd
Nick Kaye

Peter Bogaert

Managing Partner, Covington & Burling
Peter Bogaert

Shabnam Hanassab

Engagement Manager, IQVIA
Shabnam Hanassab

Sigve Sivertsen

Head of Parallel Trade, Apotek Hjärtat AB
Sigve Sivertsen

18 years’ experience from both the Norwegian and the Swedish Rx/parallel trade market.
After 10 years in the Norwegian market as a Head of Rx with responsibility of Branded products, Generics, Parallel Import, Veterinary, Licensed products and export .
Thereafter 8 years building up the Swedish Parallel Trade department for Sweden’s biggest private owned pharmacy chain, Apotek Hjärtat. Now Head of Rx with responsibility for all prescribed products.
 

Werner Berg

Partner, Baker & Mckenzie
Werner Berg

Conference agenda

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8:30

Registration & Coffee

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9:00

Chair's Opening Remarks

Janice Haigh

Janice Haigh, VP Pricing & Market Access, PAREXEL

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9:10

Session 1 - Background to parallel trade

Janice Haigh

Janice Haigh, VP Pricing & Market Access, PAREXEL

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9:15

Session 2 - PT management options

Janice Haigh

Janice Haigh, VP Pricing & Market Access, PAREXEL

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9:50

Session 3 - An overview of supply management

Janice Haigh

Janice Haigh, VP Pricing & Market Access, PAREXEL

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10:30

Morning Coffee

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11:00

Session 4 - Critical Success Factors

Janice Haigh

Janice Haigh, VP Pricing & Market Access, PAREXEL

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11:20

Session 5 - Review of Tactical Details

Janice Haigh

Janice Haigh, VP Pricing & Market Access, PAREXEL

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12:00

Session 6 - Discussion and Q&A

Janice Haigh

Janice Haigh, VP Pricing & Market Access, PAREXEL

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12:20

Closing remarks

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12:30

Close of workshop

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13:30

Registration & Coffee

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14:00

Chairs' Opening Remarks

Marie Manley

Marie Manley, Partner and Head of the Regulatory Practice, Bristows

Pat Treacy

Pat Treacy, Partner, Bristows LLC

Jeremy Blum

Jeremy Blum, Partner, Bristows LLC

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14:10

Session 1 - The key regulatory requirements

Marie Manley

Marie Manley, Partner and Head of the Regulatory Practice, Bristows

• Free movement of good framework, exhaustion of IP rights and the exception for pharmaceutical product
• Importance of the Specific Mechanism and relevant case law
• Brexit conundrum

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14:50

The Trademark issues

Marie Manley

Marie Manley, Partner and Head of the Regulatory Practice, Bristows

• Overview of the trade mark legal framework
• Discussing the packaging case
• The impact of Brexit

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15:30

Afternoon Tea

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16:00

Session 3 - Competition Issues

Marie Manley

Marie Manley, Partner and Head of the Regulatory Practice, Bristows

• Setting out the scene on Article 101and 102 of the Treaty
• Competition Stock management policy (as well as the Bayer Adalat Case)
• Dual pricing issues and corresponding cases
• The impact of Brexit

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16:40

Session 4 - Question and Answer Session

Marie Manley

Marie Manley, Partner and Head of the Regulatory Practice, Bristows

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17:20

Chairman’s Closing Remarks and Close of Day One

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8:30

Registration & Coffee

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9:00

Chair's Opening Remarks

Heinz Kobelt

Heinz Kobelt, Director European Affairs, European Association of Euro-Pharmaceutical Companies

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9:10

Status of FMD implementation – Update from Brussels

Heinz Kobelt

Heinz Kobelt, Director European Affairs, European Association of Euro-Pharmaceutical Companies

• Readiness of European Medicines Verification System (EMVS) infrastructure, and user preparedness – overview across EEA area
• Connecting manufacturers: experiences gained and learnings for connecting end users: pharmacies and wholesalers
• Integration of parallel distribution sector into the EMVS
• Anti-tampering devices
• Specific cross-border issues: recalls, thefts

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9:50

Parallel trade and antitrust - an overview of recent developments in the EU

Werner Berg

Werner Berg, Partner, Baker & Mckenzie

• Parallel trade – key issues and EU law
• Enforcement overview regarding pharma distribution
• Practical options for pharmaceutical companies

 

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10:30

Morning Coffee

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11:00

The impact of parallel trade on pharmaceutical companies

Sigve Sivertsen, Head of Parallel Trade, Apotek Hjärtat AB

• Factors and drivers of parallel trade in Europe
• The economics of parallel trade
• Trends in pharmaceutical parallel trade

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11:40

Does it always have to be a fight? Can parallel distribution and industry work together?

Antonio Mendonca Alves

Antonio Mendonca Alves, CEO, MD Pharma SA

• Product safety: Product double checking and the promise
of the FMD
• Patient access: How PD can be effective in bridging supply
chain disruptions
• Re-thinking revenue: Can parallel distribution be a useful
price segmentation tool?
 

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12:20

Networking Lunch

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13:20

Intellectual Property and regulatory law: Recent developments

Christopher Stothers

Christopher Stothers, Partner, Arnold and Porter

• IP developments in the EU and USA
• Regulatory issues
• Brexit focus: news and expectations

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14:00

Pharmaceutical pricing practices, competition law and parallel trade: What do recent antitrust abuses by pharmaceutical companies mean for parallel trade?

Flemming Wagner, CEO, ABACUS MEDICINE A/S

• Overview of key recent cases in UK and EC
• Main issues
• Regulatory context in which these have occurred
• What are the implications of these cases for parallel trade
 

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14:40

Afternoon Tea

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15:10

Economics of pay for delay deals

Farasat Bokhari

Farasat Bokhari, Senior Lecturer in Economics, UEA, University of East Anglia

• What are pay for delay deals?
• Why do they come about?
• How much do they cost the society?
• What can we do about it?

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15:50

The evolving parallel trade environment in Europe

Neil  Grubert

Neil Grubert, Independent Market Access Consultant,

• How has Brexit already affected parallel trade, and what are its long-term implications?
• What impact will pricing measures such as international reference pricing, cross-border pricing alliances and pricing transparency have on parallel trade?
• What policies are national governments exploring to manage parallel trade?
• How are brand manufacturers responding to parallel trade

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16:30

Chair’s Closing Remarks and Close of Day One

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17:30

Professor Gianfrate was unable to attend this meeting but has provided his presentation for us.

Fabrizio Gianfrate

Fabrizio Gianfrate, Professor of Health Economics, University of Ferrara

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8:30

Registration & Coffee

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9:00

Chair's Opening Remarks

Heinz Kobelt

Heinz Kobelt, Director European Affairs, European Association of Euro-Pharmaceutical Companies

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9:10

Medicine shortages in Ireland – causes, impact and mitigation

Darragh O'loughlin

Darragh O'loughlin, Secretary General, Irish Pharmacy Union

• Current Shortages – what medicines are affected and why?
• Mitigating the Impact – what are we doing and is it working?
• Potential Future Strategies – what works elsewhere and are export bans a solution?

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9:50

Medicine quotas: What is the impact on patients and will FMD help?

Nick Kaye

Nick Kaye, Superintendent Pharmacist , S.Kaye & Son Ltd

• What are quotas and why do we have them?
• How do they impact on patients?
• How they impact on trade?
• FMD’s role in quotas

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10:30

Morning Coffee

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11:00

Market Access post Brexit

Felipe Florez-Arango

Felipe Florez-Arango, Head of Finance, Europe, Shire

Session reserved for: Felipe A Florez-Arango, Head of Finance, Region Europe, Shire

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11:40

Parallel trade – the German perspective on the market

• Drivers of parallel trade with pharmaceuticals in Europe.
Focus: Germany
• Parallel trade and the pressure on the prices of
pharmaceuticals. Quo Vadis parallel trade?
• Latest trends of pharmaceutical parallel trade
 

Shabnam Hanassab

Shabnam Hanassab, Engagement Manager, IQVIA

Frank  Weissenfeldt

Frank Weissenfeldt, Senior Manager, Supplier Relations, IQVIA

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12:20

Networking Lunch

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13:20

Emerging aspects of parallel trade: Improved access, emergency supplies, social responsibility

Mikas Rimantas

Mikas Rimantas, Business Development Director, Lexano

• Partnering with healthcare authorities for improved patient access to medicines
• Emergency supplies for clinical trials, hospitals and individual patients
• Social responsibility aspects of parallel trade
 

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14:00

Patient access to epilepsy drugs in light of pharmaceutical parallel trade

• MHRA review: Guidance on patients getting the right version of epilepsy
• The importance of patients receiving the same version of their epilepsy drug
• Issues with generic prescribing and parallel imports
• Differing opinions on consistency of supply

Ian  Walker

Ian Walker , Chairman , Epilepsy Action

Jayne Burton

Jayne Burton, Elected Trustee, Epilepsy Action

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14:40

Afternoon Tea

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15:10

Market access post Brexit

John Jolley

John Jolley, Managing Director , PharmaConsult Global Ltd

• EU Product registration
• Impact on medicines supply chain
• Impact on stock shortages
• Impact on pricing

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15:50

Key commercial dynamics for parallel trade against the legal and regulatory background

Peter Bogaert

Peter Bogaert, Managing Partner, Covington & Burling

• Commercial drivers in the pharmaceutical parallel trade market
• Branding aspects of parallel imported medicines
• Specific labelling aspects of parallel imports
• Concrete impact of the legal and regulatory principles
• Concrete product examples

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16:30

Chair’s Closing Remarks and Close of Day Two


CEO
MD Pharma SA
Partner
Arnold and Porter
Secretary General
Irish Pharmacy Union
Professor of Health Economics
University of Ferrara
Senior Lecturer in Economics
UEA, University of East Anglia
Head of Finance, Europe
Shire
CEO
ABACUS MEDICINE A/S
Senior Manager, Supplier Relations
IQVIA
Director European Affairs
European Association of Euro-Pharmaceutical Companies
Chairman
Epilepsy Action
VP Pricing & Market Access
PAREXEL
Elected Trustee
Epilepsy Action
Managing Director
PharmaConsult Global Ltd
Business Development Director
Lexano
Independent Market Access Consultant
Superintendent Pharmacist
S.Kaye & Son Ltd
Managing Partner
Covington & Burling
Engagement Manager
IQVIA
Head of Parallel Trade
Apotek Hjärtat AB
Partner
Baker & Mckenzie

Official Media Partner

Official Publication

Supporters

Workshops

Parallel trade management strategies

Parallel trade management strategies

Holiday Inn Kensington High Street
8 February 2018
London, United Kingdom

[Lawyer perspectives] on Parallel Trade

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[Exclusive Content] - Bristows on Paralell Trade

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[ATTENDEE LIST] - Parallel Trade 2018 by Job Title

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[ATTENDEE LIST] - PARALLEL TRADE 2018 by Company

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[ATTENDEE LIST] - PARALLEL TRADE 2018 by Country

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[ATTENDEE LIST] - PARALLEL TRADE 2017

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European Pharmaceutical Law Review (EPLR)

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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, SAE Media 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@saemediagroup.com

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UK Office
Opening Hours: 9.00 - 17.30 (local time)
SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
Website: http://www.smgconferences.com Email: events@saemediagroup.com
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