This document provides information on the 13th Annual Conference on Parallel Trade happening February 5-6, 2019 in London. The conference will address topics such as the impact of parallel trade on patient safety and pharmaceutical companies, Brexit's impact on parallel trade, and challenges around implementing the Falsified Medicines Directive. Speakers will represent companies such as Allergan, Almirall, Edwards Life Sciences, and the European Alliance for Access to Safe Medicines. Participants can register online and save money by registering earlier. The conference is organized by SMi Pharma.

1. HIgHLIgHTS IN 2019:
• Learn about the impact of parallel trade in patient safety and
placing the patient at the forefront of considerations
• Discuss the effect of parallel trading on companies who
distribute products both nationally and internationally
• Hear about the progress with implementing FMD in pharmacies
as the last point in the supply chain
• Discover the root causes and solutions for shortages or generic
medicines and debate how and why they occur
• Understand the margins for movement within competition law in
line with best business practices
CHAIR FOR 2019:
• Heinz Kobelt, Director European Affairs, European
Association of Euro-Pharmaceutical Companies
KEY SPEAKERS INCLUDE:
• Nerea Blanqué, Senior Global Market Access & Pricing
Manager, Almirall
• Miranda Cole, Partner Antitrust/ Competition, Covington &
Burling LLP
• Mike Isles, Executive Director, European Alliance for Access
to Safe Medicines
• Shabnam Hanassab, Engagement Manager, IQVIA
• Felipe Florez-Arango, CFO, Allergan
• Maarten Van Baelen, Market Access Director, Medicines for
Europe
• Christopher Stothers, Partner, Freshfields Bruckhaus Deringer
REGISTER BY 31ST OCTOBER AND SAVE £400
REGISTER BY 30TH NOVEMBER AND SAVE £200
REGISTER BY 14TH DECEMBER AND SAVE £100
www.parallel-trade.com
Register online or fax your registration to +44 (0) 870 9090 712
or call +44 (0) 870 9090 711
SMi Pharma
@SMiPharm
#SMi
Workshop A: Parallel Trade & Brexit.
What to expect?
Workshop Leader:
Tushar Patel MRPharmS, MBA, MTOPRA, PGDIP,
Key Pharmaceuticals Ltd
08.30 - 12.30
PLUS TWO INTERACTIVE HALF-DAY PRE-CONFERENCE WORKSHOPS | MONDAY 4TH FEBRUARY 2019, HOLIDAY INN KENSINGTON FORUM, LONDON, UK
HOLIDAY INN KENSINGTON FORUM, LONDON, UK
SMi presents their 13th Annual Conference on...
Parallel Trade
WORKSHOPS: 4TH
CONFERENCE:
5TH - 6TH
FEB
2019
Workshop B: Understanding IP, regulatory and
competition law issues in pharmaceutical parallel trade
Workshop Leaders:
John Schmidt, Partner, Arnold & Porter
Kathy Harford, Professional Support Lawyer, Arnold & Porter
13.30 - 17.00
Addressing Competition law and FMD challenges

2. OCTOBER 2018
Cell & Gene Therapy
10th - 11th October 2018,
London, UK
Orphan Drugs
17th - 18th October 2018,
London, UK
NOVEMBER 2018
Superbugs & Superdrugs USA
12th - 13th November
2018, New Jersey, USA
Biosimilars North America
14th - 15th November
2018, New Jersey, USA
Lyophilization USA
15th - 16th November
2018, New Jersey, USA
Ophthalmic Drugs
26th - 27th November
2018, London, UK
DECEMBER 2018
Cold Chain Distribution
10th - 11th December
2018, London, UK
JANUARY 2019
Pre-Filled Syringes &
Injectable Drug Devices
16th - 17th January 2019
London, UK
PharmaceuticalMicrobiology
21st - 22nd January 2019
London, UK
Social Media in the
Pharmaceutical Industry
21st - 22nd January 2019
London, UK
FEBRUARY 2019
Parallel Trade
5th - 6th February 2019
London, UK
3D Cell Culture
20th - 21st February 2019
London, UK
RNA Therapeutics
20th - 21st February 2019
London, UK
MARCH 2019
Superbugs & Superdrugs
18th - 19th March 2019
London, UK
Drug Discovery Chemistry
18th - 19th March 2019
London, UK
APRIL 2019
Adaptive Designs
1st - 2nd April 2019
London, UK
Pre-Filled Syringes East Coast
8th – 9th April 2019
Boston, USA
Microbiology East Coast
10th - 11th April 2019
Boston, USA
MAY 2019
Injectable Drug Delivery
15th - 16th May 2019
London, UK
Pain Therapeutics
20th - 21st May 2019
London, UK
Highly Potent Active
Pharmaceutical Ingredients
20th - 21st May 2019
London, UK
JUNE 2019
Prefilled Syringes West Coast
3rd - 4th June 2019
San Diego, USA
Lyophilisation
3rd - 4th June 2019
London, UK
Microbiology West Coast
5th - 6th June 2019
San Diego, USA
SMi PHARMACEUTICAL FORWARD PLANNER
Parallel Trade
Day One | Tuesday 5th February 2019 www.parallel-trade.com
08.30 Registration & Coffee
09.00 Chairman’s Opening Remarks
Heinz Kobelt, Director European Affairs, European Association of
Euro-Pharmaceutical Companies
Parallel Trade and Patient Safety
09.10 KEYNOTE SESSION: The fundamentals of parallel trade
• The concepts behind the practice and specific ways of working
• How a parallel trading business is run and the backing rational
• Specialisation and regional considerations
Eric Noehrenberg, Director Market Access, Edwards Life Sciences
09.50 The impact of parallel trade on patient safety
• Parallel trade management to ensure patient safety
• Case study presenting a case of patient safety issues
• The creation of shortages through the parallel export of
medicines from states with lower costing medicines
• Would there be any way to change the market dynamic to
reduce the level of shortages
Nerea Blanque, Senior Global Market Access and Pricing Manager,
Almirall
10.30 Morning Coffee
11.00 Patients First
• Patients: Centre stage of everything we do / should do
• Integrity of the Supply Chain
• End-to-End supply chain: A MUS, not an option
Felipe Florez-Arango, CFO, Allergan
Brexit’s Impact on Parallel Trade
11.40 The economic impact of parallel trade on consumers
– will Brexit make a difference?
• Effects of parallel trade on patients’ access to patented
medicines
• Key risks and policy implications.
• What opportunities and risks will Brexit offer?
Deborah Drury, Senior Consultant, Europe Economics
12.20 Latest Trends of European Parallel Trade
• Parallel import trends in year 2018
• Drivers of parallel trade across Europe
• Brexit and possible impacts on supply chain
Shabnam Hanassab, Engagement Manager, IQVIA
13.00 Networking Lunch
14.10 Entry deterrence, market shares and growth
• Strategic and non-strategic reasons for introducing additional
drugs by a monopolist near the end of market exclusivity period
for the original drug.
• Are these drugs introduced to deter generic entry, and if so, is it
an effective strategy?
• Post-entry, do additional product and pack variations by an
incumbent help with revenue growth of the business unit?
Farasat A.S. Bokhari, Senior Lecturer (Associate Professor),
University of East Anglia
14.50 The impact of parallel trading on pharmaceutical companies
who distribute products both nationally and internationally
• The business and economic impact of parallel trading on
pharmaceutical companies and pharmaceutical manufacturers
• The adjustment procedures which are put in place to avoid
adverse effects
• The creation of competition within the market and the pricing
strategies that companies adopt
• The assessment of demand based on the occurrence
of parallel trading
Flemming Wagner, CEO, ABACUS MEDICINE A/S
The Falsified Medicines Directive
15.30 The European Medicines Verification System before the big bang!
Are supply chain operators ready?
• System readiness: rollout of repository system across EEA area –
experiences and last-minute obstacles
• Company readiness: manufacturers, parallel distributors, wholesalers,
hospital pharmacies and community pharmacists all had to prepare
for compliance with FMD obligations – Lessons learnt
• Funding of the EMVS and other remaining challenges
• Implications on supply chain: is FDM disruptive? Are shortages to
be feared? And Brexit is around the corner!
Heinz Kobelt, Director European Affairs, European Association of
Euro-Pharmaceutical Companies
16.10 Afternoon Tea
16.40 PANEL DISCUSSION: The future of Parallel Trade and
supply chain distribution:
• The impact of parallel trade on the supply chain
• The impact on pharmaceutical companies through the
economic actions as a result
• Future regulations and implementations which will impact
existing models
• The speculated effect of these changes within the market
Moderator: Heinz Kobelt, Director European Affairs, European
Association of Euro-Pharmaceutical Companies
Felipe Florez-Arango, CFO, Allergan
Nerea Blanque, Senior Global Market Access and
Pricing Manager, Almirall
Eric Noehrenberg, Director Market Access, Edwards Life Sciences
Vimal Unewal, Senior Manager In Market Supply, Ferring
Pharmaceuticals
17.20 The practical impact of FMD implementation on trade
• A more practical outlook on the effect that the implementation of
FMD will have on parallel trade, from a parallel trader’s perspective
• The impact on day-to-day processes of wholesalers, parallel
traders and pharmacies
• The access of data generated towards member states
Antonio Mendonca Alves, CEO, MD Pharma
18.00 Fighting fakes by raising public awareness
• The supply chains – legitimate and illegitimate
• Demand side - fuelling the illegitimate Supply Chain
• How can we monitor and manage the demand?
• The role of the EU Commission and Member States in raising awareness
Mike Isles, Executive Director, European Alliance for Access
to Safe Medicines
18.40 Chairman’s Closing Remarks and Close of Day One
Register online at www.parallel-trade.com
SPONSORSHIP AND EXHIBITION OPPORTUNITIES
SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company’s marketing strategy. Prime
networking opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specific to your industry.
Should you wish to join the increasing number of companies benefiting from sponsoring our conferences please call:
Alia Malick, Director on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk

3. Parallel Trade
www.parallel-trade.com Day Two | Wednesday 6th February 2019
Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
MARKETING PARTNERSHIP OPPORTUNITIES
SMi Group is offering companies the opportunity to partner on our dedicated events in order to help raise your company profile,
add value, create awareness of your products/services to our key audience within the pharmaceutical industry. Interested in partnering?
Contact Jinna Sidhu, Marketing Manager on +44 (0) 207 827 6088 or email: HSidhu@smi-online.co.uk
We are proud to be partners with:
Supported by:
08.30 Registration Coffee
09.00 Chairman’s Opening Remarks
Heinz Kobelt, Director European Affairs, European Association of
Euro-Pharmaceutical Companies
THE SUPPLY CHAIN AND SHORTAGES
09.10 KEYNOTE SESSION: The supply chain and the importance of track
and trace along with the combination of systems
• The inclusion of track and trace along with a unique identifier
system
• How does this integration of systems cause hindrances when the
product travels through more complicated movements?
• Are there any problem areas within the checking-in and out?
Sigve Sivertsen, Head of Parallel Trade, Apotek Hjärtat AB
09.50 The impact of parallel trade within the lower cost states
• Overview of Eastern European (EE) pharma markets
• Key difference in supply chain regulation in EE
• Data availability in EE
Martin Slegl, Regional Principal of East Europe, IQVIA
10.30 Morning Coffee
11.00 Shortages of generic medicines: root causes and solutions
• Drivers of medicines shortages in an off-patent, multi-source
sector
• Pressure of costly regulatory/quality procedures and cost-
containment measures on generic medicines industry
• Recommendations to prevent medicine shortages (addressing
the root causes)
Maarten Van Baelen, Market Access Director, Medicines for Europe
11.40 PANEL DISCUSSION: Shortages - how and why do
they occur?
• The hypothesis behind where exactly within the
market the shortages within regions are caused
• The potential implementation of incentives towards companies
to reduce this occurrence?
• Would there be a way to track shortages in order to aid the
reduction of them?
Moderator: Heinz Kobelt, Director European Affairs, EAEPC
Kasper Ernest, Secretary General, European Association of
Euro-Pharmaceutical Companies
Maarten Van Baelen, Market Access Director, Medicines for Europe
Martin Slegl, Regional Principal of East Europe, IQVIA
12.20 Review of recent excessive pricing and pay for delay cases and
the implications for pricing
• Current regulatory framework for prices of branded medicines
• Relationship between prices of branded medicines and parallel
trade prices
• Overview of recent branded pharma cases in UK and EC
• Implications of recent cases for parallel trade prices
Iona McCall, Senior Vice President, AlixPartners
13.00 Networking Lunch
THE LEGAL ASPECTS OF PARALLEL TRADE WITHIN IP,
ANTI-TRUST AND COMPETITION LAW
14.10 KEYNOTE SESSION: How to co-exist but do not break anti-trust rules
- the margins for movement within competition law in line with the
best business practices
• The best way to establish patient level demand for a particular
patient set, given the arguable changing goal-posts in the
current landscape
• Meeting the basic obligation of domestic demand whilst not
catering towards extra-ordinary demand in order to keep in line
with business sense
• The strategy through which an interplay between bottom-bound
capacity and a cap of supply is maintained
• Applied examples of treatments where the difficulty of
establishment of demand comes in i.e. with cancer treatments
which could be used to treat multiple types of cancer and
situations in which a company could be seen to be purposefully
constraining a competitor’s behavior
Miranda Cole, Partner, Covington Burling
14.50 Is there a harmonised approach of Parallel Trade by authorities
and courts in the EU?
• The implementation of historic ECJ case law in the member states
• Differences in impact of the Kohlpharma-ruling in the member states
• Views of EU authorities
• What are the consequences for the business?
John Lisman, Attorney, Consultant, Trainer, Lisman Legal Life
sciences B.V.
15.30 Exhaustion of Intellectual Property
• Trademark law and the re-selling of products once it is within the
marketplace
• Re-packaging methods used within the re-selling of
pharmaceutical products
• The impact of new packaging requirements (i.e. safety features
according to FMD: unique identifiers and anti-tampering devices)
impact on re-packaging for parallel distribution
Christopher Stothers, Partner, Freshfields Bruckhaus Deringer
16.10 Afternoon Tea
16.40 The European Commission’s paper on the obligation of
continuous supply
• What the paper covers and the procedural practices for
companies within the industry that it outlines
• The impact of these practices on the market and company
obligations towards the consumer
• The rationale behind these policy choices and the potential
procedural terminations they include
• The link to the obligatory supply considerations along with
tackling shortages
Kasper Ernest, Secretary General, European Association
of Euro-Pharmaceutical Companies
17.20 Evolution of Parallel trade: scenarios and strategies
• Future impact of PT for manufacturer, wholesale
and pharmacist
• Possible win-win solutions
• The Amazon effect on PT
• EU and UK Payer evolution on PT
Fabrizio Gianfrate, Professor of Health Economics,
University of Ferrara and Rome
18.00 Chairman’s Closing Remarks and Close of Day Two

4. HALF DAY PRE-CONFERENCE WORKSHOP
Monday 4th February 2019
Holiday Inn Kensington Forum, London, UK
8.30 - 12.30
Parallel Trade Brexit. What to expect?
Workshop Leader:
Tushar Patel MRPharmS, MBA, MTOPRA, PGDIP,
Key Pharmaceuticals Ltd
Workshop Overview:
This workshop will focus on Parallel Trade- its definition and
what exactly is meant by parallel trade. What products are
relevant to parallel trade and why.
How parallel trade has evolved over the decade and the
business models established in the UK. Explore the other side
– rest of EU and see what parallel trade plays in everyday
pharmaceutical trade.
Stock shortages and FMD has recently been threats to Parallel
Trade – what and how are these occurring and why are they
important to the industry.
Then Brexit was announced, and we can no go into different
scenarios about Brexit and how the industry and pharma
companies can prepare, plan and embrace this unknown
encounter.
Why should you attend this workshop:
A brief insight into the history, regulations and strategies
employed to parallel trade. Then some case studies to
explore different strategies pharma companies can adopt to
plan ahead for Brexit.
Also explore the impact of parallel trade on Pharma-
covigilance, generics, parallel imports across EU boundaries.
Agenda
8.30 Registration and coffee
9.00 Opening remarks and introductions
9.10 Session 1: Background on Parallel Trade
• Formation of EU and birth of PT
• EU treaties and rules of PT
• Industry models for parallel trade and products
of concern
• Trading models adopted by Pharma companies.
• The Grey market
• Consequences and outcomes of PT
9.50 Session 2: Regulatory landscape current and for
Brexit
• What are the regulatory requirements for PT
• Pro Cons of Brexit on PT
• Impact of pharma companies and products on
both sides
10.30 Morning Coffee
11.00 Session 3: Case studies to engage candidates to
explore scenarios for pharma industry to prepare
for Brexit and its impact to product supplies and
patients across EU.
11.40 Session 4: Recap and evaluate if workshop has
met initial expectations. QA.
12.30 Closing Remarks and End of Workshop
About the Workshop Leader:
Tushar Patel, MRPharmS, MBA, MTOPRA, PGDIP
Registered pharmacist in 1992 following a year training at Milton
Keynes hospital. Worked as a community pharmacist for some
years whilst also involved in regulatory projects for start-up of
parallel import companies in the UK. Facilitated application
for MHRA Manufacturing Licences and PL(PI) applications for
various clients. Completed my MBA in 1996 and progressed
along the community and wholesale of pharmaceuticals. Having
established a group of four retail pharmacies I progressed with my
initial passion for regulatory and generics.
Currently fully engrossed with our formulation development
of generics and formed a fully encompassed pharma
company with all regulatory disciplines in house with our own
Marketing Authorisations. I am an EU QPPV leading our in house
Pharmacovigilance department and also a trainee EU QP, having
our own Manufacturing Licence.
Our ambition has already been achieved to develop,
manufacture and dispense our medicines to our own customer in
our own pharmacies. Now we are looking ahead to better serve
patients globally and improve where possible to safer medicines.
About the Organisation:
Key Pharmaceuticals Ltd Our consultancy services have
been established for over 15 years. Our professional services
are delivered with extensive experience, knowledge and skill
in formulation and development, manufacture, distribution,
retail and marketing of pharmaceuticals in Europe.
• Proficient in all GxP disciplines. GDP, GMP, PV, GCP.
• Formulation Development
• Project Management and product life cycle strategies.
• Regulatory Affairs and representation to MHRA

5. HALF DAY PRE-CONFERENCE WORKSHOP B
Monday 4th February 2019
Holiday Inn Kensington Forum, London, UK
13.30 - 17.00
Understanding IP, regulatory and
competition law issues in
pharmaceutical parallel trade
Workshop Leaders:
John Schmidt, Partner, Arnold Porter LLP
Kathy Harford, Professional Support Lawyer, Arnold Porter LLP
Workshop Overview:
This workshop will explore in depth how IP, regulatory
and competition law can affect parallel trade in the
pharmaceutical industry. Through interactive case studies, it
will provide insight into the potential competition law issues
raised by strategies to manage parallel trade, the use of trade
mark and patent rights to prevent the sale of repackaged
parallel imports, and how regulatory notifications can be
monitored to assess risk.
Why should you attend?
• Understand the legal framework regulating parallel trade
of pharmaceuticals
• Participate in interactive case studies considering common
competition law and IP issues
• Analyse the risks of parallel trade management strategies
Agenda
13.30 Registration and coffee
14.00 Opening remarks and introductions
14.10 Case Study 1: Competition law and management
strategies
• Legal principles - Articles 101/102 TFEU and case
law
• Quota systems and potential risks
• Agency (direct to pharmacy/hospital) systems
and potential risks
• Other competition risks and red flags
14.50 Case Study 2: Trade mark exhaustion and
repackaging
• Legal principles - trade mark exhaustion
• BMS conditions - when and how can goods be
repackaged?
• Consent to sale of goods in the EEA - what about
related and group companies?
15.20 Afternoon Tea
15.50 Case Study 3: Regulatory and patent notifications
• The Specific Mechanism - patent protection and
parallel trade
• Monitoring notifications for risk
16.30 QA
17.00 Closing Remarks and End of Workshop
About the Workshop Leader:
Kathy Harford, Professional Support Lawyer, Arnold Porter.
Kathy Harford is a Professional Support Lawyer in Arnold
Porter’s London office, supporting the IP and litigation
practices. She has a particular focus on IP disputes, with
experience of patent, trade mark and trade secrets actions
in the English courts, opposition proceedings at the European
Patent Office, and coordinating IP litigation in multiple
jurisdictions across Europe.
John Schmidt, Partner, Arnold and Porter.
John Schmidt leads the UK Competition team in London.
He has more than two decades of experience dealing with
competition authorities and courts in the UK and the EU and
regularly advises on complex competition conduct issues,
investigations, litigation, and merger cases. He is dual-qualified
in the UK and Germany and has a particular focus on the life
sciences, consumer goods, finance, and infrastructure sectors.
Mr.Schmidthasextensiveexperienceadvisingpharmaceutical
and medical device companies on pricing matters, including
a number of reverse payment patent settlement cases both
at the EU and UK level. A significant recent success involved a
no grounds for action case closure for Teva Pharmaceuticals
in the CMA’s investigation into paroxetine after a statement
of objections, a supplemental statement of objections, and
two oral hearings. He is currently involved in a number of CMA
investigations in the pharma sector.
About the Organisation:
Arnold Porter’s Competition, IP and Life Sciences Regulatory
practices are recognized worldwide for their breadth, depth,
and excellence. With a unique, fully integrated regulatory
practice, competition experience covering the full range
of US and EU antitrust issues, and prominent IP litigation and
transactional practices, Arnold Porter is able to advise a
huge range of life sciences clients on complex cross-practice
issues such as parallel trade.

6. Parallel Trade
Workshops: 4th February 2019, Holiday Inn Kensington Forum, London, UK
Conference: 5th-6th February 2019, Holiday Inn Kensington Forum, London, UK
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