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OUR SPECIAL FEATURES
•	On-Stage Interview
with EFPIA
•	HCP insight •	Special debate •	Focused discussions
KEY BENEFITS OF ATTENDING
•	Get an update on the implementation of
Disclosure Code and the first outcomes and
evaluate your implementation process
•	Unravel compliance challenges relating to data
privacy
•	Define Fair Market Value and develop a consistent,
simple and transparent method for your company
•	Learn how to optimise interactions with HCPs
and HCOs through a fully compliant and
transparent strategy to obtain consent
•	Find out compliance implications and concerns for
merging corporate cultures
•	Uncover how to establish an adequate investigation
manual and procedures
4th
Annual
Corporate
Compliance
& Transparency
in the Pharmaceutical Industry
24 - 25 February 2016
Mövenpick Hotel Zürich- Regensdorf, Zürich
OUR SPEAKER PANEL
Richard Bergstrom 
EFPIA | Director General
Nina Stoeckel | Merck KGaA
Director, Head of Group
Compliance Programs LE-CP
Richard Walters  
GlaxoSmithKline
Head of Ethics & Compliance,
Pharma Europe
See full speaker panel on the next page
GRPTRUE DILIGENCE
Media Partners:
OUR SPEAKER PANEL
Nina Stoeckel | Merck KGaA
Director, Head of Group Compliance Programs LE-CP
Karl Boonen | Johnson & Johnson
Senior Director Business Practices and Compliance
EMEA & Canada
Marcela Kirberger | Sandoz
Global Compliance Officer
Christophe Lesguer | Mylan
Vice President, Chief Compliance Officer Europe
Richard Walters | GlaxoSmithKline
Head of Ethics & Compliance, Pharma Europe
Detlef Geiges | AstraZeneca | Head of Corporate
Governance/ Area Compliance Lead DE, AT, CH
Neli Nedkova | Boehringer-Ingelheim
Head of Compliance & Ethics Central and
Eastern Europe
Milena Yakimova | Actavis
Director Ethics & Compliance – Central Eastern
& South Eastern Europe
Meltem Ozker Gunduz | Novo Nordisk
Legal Affairs & Compliance Director Business
Area Near East (BANE)
Marit Pless | InterMune
European Legal Counsel, Ethical Compliance Director
Leonardo Silva | Acino Pharma AG
Head of Compliance
Maria Teresa Rico | Biogen
EU Regional Compliance Officer and JV Biosimilars
Compliance Officer
Dominique Oliver Ahnsehl  
Bayer HealthCare | Compliance Counsel
Michiel Lodewijks | Roche | Compliance Officer
Richard Bergstrom | European Federation
of Pharmaceutical Industries and Associations
- EFPIA | Director General
Adrian van den Hoven | European Generic
and Biosimilar Medicines Association - EGA
Director General
Carin Smand | European Hematology
Association - EHA | Managing Director
Milada Brabcova | Eli Lilly | Compliance Director
Neeraj Singhal | MediSpend
Vice President, Product Management and Marketing
Katie Jacyna | MediSpend
Product Manager
Tim Robinson, Esq. | MediSpend
Chief Knowledge Officer / General Counsel
Nicolas Giannakopoulos | Global Risk Profile
Founding Partner
Anthony Papon | Accenture | Managing Director
Paul Melling | Baker & McKenzie | Partner
KPMG
OUR ADVISORY COMMITTEE
Esther van Weert
F. Hoffmann - La Roche
Pharma Healthcare Compliance Leader
Europe
Gian Luca Trinei
Pfizer
Chief Compliance Officer
Marit Pless
InterMune
European Legal Counsel
Milada Brabcova
Eli Lilly,
Compliance Director
Milena Yakimova
Actavis |Director Ethics & Compliance
– Central Eastern & South Eastern Europe
Hal Glasser
Former Senior Director Chief Ethics
& Compliance Officer
Sanofi Pasteur MSD
EVENT INTRODUCTION
The past decade have witnessed a wave of global transparency in the pharmaceutical industry, and 2015 has marked the start of
a new era in Europe. Companies have exerted to design and implement processes that meet spend transparency and disclosure
requirements. From 2016, pharma have to make public its payments to doctors and healthcare organisations in Europe, which is not
only a huge technical challenge, but also a major cultural shift.
This conference will serve as a platform to discuss compliance and transparency areas of key concern. Do not hesitate, take this great
networking opportunity and join us in Zürich!
Who will you meet?
CxOs, SVPs, Vps, Global heads, Heads, Directors, Officers, Counsels, Managers of Pharma/ Biotech companies responsible for
Compliance, Ethics/ Business Ethics, Legal, Regulatory Affairs, Risk Monitoring etc. Representatives of Law firms, Governmental
bodies, Audit companies, etc.
Supporting Partner:
Booking line: tel:  +421 257 272 155, fax:  421 255 644 490
email:   lesly.solei@fleming.events, www.fleming.events
Sponsor: Partner Association:Silver Sponsor: Bronze Sponsor:
www.flemingeurope.com
3rd
Annual
CorPorAte
ComPliAnCe
& trAnSPArenCy
in the Pharmaceutical industry
25th
– 26th
February 2015, Zürich, Switzerland
Swissotel Zurich
Our Speaker panel:
Julie BOnhOmme,
eFpia
legal Affairs &
Compliance Deputy
Director
klauS GeldSetzer
Santen
Chief Compliance
officer europe
Ole Wendler
pederSen
nOvO nOrdiSk
General Counsel
region europe
Director legal,
Compliance &
Business Development
nick tyler
takeda
pharmaceuticalS
internatiOnal
Director Compliance
& Data Privacy
milada BraBcOva
eli lilly
Compliance Director
milena yakimOva
actaviS
Director ethics &
Compliance – Central
eastern & South
eastern europe
nader khedr
SandOz
Head regional
Compliance - meA
SanGeetha
karpOre kumar
dr. reddy‘S
laBOratOrieS
Associate Director,
Compliance Head
emerging markets
tOmaSz kruk
mallinckrOdt
pharmaceuticalS
Director international
Compliance
eSther van Weert
rOche and rOche
diaGnOSticS
Pharma Healthcare
Compliance leader
- europe
JarOSlav vaSil
Bayer
healthcare
Senior Business
Advisor
marit pleSS
intermune
internatiOnal
european legal
Counsel
dan zavOdnick
Bayer
healthcare llc
Corporate Counsel
JakuB dvOřáček
aiFp (czech
aSSOciatiOn OF
innOvative
pharmaceutical
induStry)
executive Director
rOlF Stahel
eurOpean SOciety
FOr medical
OncOlOGy (eSmO)
President
timOthy
rOBinSOn
mmiS inc./
mediSpend
Chief Knowledge
officer & General
Counsel
martiJn de
kieWit
kpmG
Head of ethics and
Compliance
management
paul mellinG
Baker & mckenzie
Partner
Geert van
GanSeWinkel
pOlariS
SOlutiOnS
managing Director
europe
Sponsor: Partner Association:Silver Sponsor: Bronze Sponsor:
www.flemingeurope.com
3rd
Annual
CorPorAte
ComPliAnCe
& trAnSPArenCy
in the Pharmaceutical industry
25th
– 26th
February 2015, Zürich, Switzerland
Swissotel Zurich
Our Speaker panel:
Julie BOnhOmme,
eFpia
legal Affairs &
Compliance Deputy
Director
klauS GeldSetzer
Santen
Chief Compliance
officer europe
Ole Wendler
pederSen
nOvO nOrdiSk
General Counsel
region europe
Director legal,
Compliance &
Business Development
nick tyler
takeda
pharmaceuticalS
internatiOnal
Director Compliance
& Data Privacy
milada BraBcOva
eli lilly
Compliance Director
milena yakimOva
actaviS
Director ethics &
Compliance – Central
eastern & South
eastern europe
nader khedr
SandOz
Head regional
Compliance - meA
SanGeetha
karpOre kumar
dr. reddy‘S
laBOratOrieS
Associate Director,
Compliance Head
emerging markets
tOmaSz kruk
mallinckrOdt
pharmaceuticalS
Director international
Compliance
eSther van Weert
rOche and rOche
diaGnOSticS
Pharma Healthcare
Compliance leader
- europe
JarOSlav vaSil
Bayer
healthcare
Senior Business
Advisor
marit pleSS
intermune
internatiOnal
european legal
Counsel
dan zavOdnick
Bayer
healthcare llc
Corporate Counsel
JakuB dvOřáček
aiFp (czech
aSSOciatiOn OF
innOvative
pharmaceutical
induStry)
executive Director
rOlF Stahel
eurOpean SOciety
FOr medical
OncOlOGy (eSmO)
President
timOthy
rOBinSOn
mmiS inc./
mediSpend
Chief Knowledge
officer & General
Counsel
martiJn de
kieWit
kpmG
Head of ethics and
Compliance
management
paul mellinG
Baker & mckenzie
Partner
Geert van
GanSeWinkel
pOlariS
SOlutiOnS
managing Director
europe
Past Conferences in Numbers
60%	 Western Europe
18%	Central and Eastern
Europe
16%	 Southern Europe
6%	USA
GeographicalBreakdownNumberofAttendees
Prague 2013
Berlin 2014
Zürich  2015
Very constructive! Very well organised!
Group Corporate Governance and Compliance Officer Director, Helsinn
Very interesting and useful to hear other companies experience and learn based on this
Compliance Manager, GlaxoSmithKline
Excellent opportunity to gain knowledge and share experience
Deputy Head of Legal Affairs Division, Hemofarm
On-Stage Interview The Talk Expert Panels
Special Debate Networking Interactive App
CONFERENCE FEATURES
Booking line: tel:  +421 257 272 155, fax:  421 255 644 490
email:   lesly.solei@fleming.events, www.fleming.events
CONFERENCE DAY 1 | 24th
February 2016
  8:30	 Registration coffee
  9:00	 Welcoming note from Fleming.
  9:05	 Opening remarks from the Chair
  9:10	 On-stage Interview: EFPIA – Update on 
Implementation of Disclosure Code
•	 Do‘s and don‘ts when implementing EFPIA‘s codes
•	 What‘s going to happen next once the data is disclosed?
•	 What are the challenges anticipated regarding external
communication?
•	 What are the challenges in specific countries related to
disclosure?
Richard Bergstrom | European Federation of
Pharmaceutical Industries and Associations - EFPIA
Director General
  9:40	 Transparency Obligations – Examples 
of Implementation and First Outcomes
Transparency obligations are on the rise. The EFPIA Code
on Disclosures of Transfers of Value From Pharmaceutical
Companies to Healthcare Professionals and Healthcare
Organisations required reporting starting in 2016 for
2015 spend.
•	 Evaluation of the implementation
•	 A walk through of the practical implementation of
transparency processes
•	 Industry first observations after disclosure of data
•	 Country by country differences in central reporting
•	 Progress on managing communication with healthcare
professionals
Neli Nedkova | Boehringer-Ingelheim
Head of Compliance  Ethics Central and Eastern Europe
Dominique Oliver Ahnsehl | Bayer HealthCare
Compliance Counsel
10:30	 Morning coffee  networking
11:00	 Local Perspective: Disclosure and 
Transparency Lessons Learned
Complying with the EFPIA Code on Disclosure of Transfers
of Value to Healthcare Professionals and Healthcare
Organisations will be a very complex business. This is not
least because each of the 33 countries involved has its own
slightly different approach to complying with the Code.
•	 Lessons learned from one location can be applied as
more associations and countries implement transparency
requirements
Michiel Lodewijks | Roche | Compliance Officer
Meltem Ozker Gunduz | Novo Nordisk | Legal Affairs
 Compliance Director Business Area Near East (BANE)
Milena Yakimova | Actavis | Director Ethics
 Compliance – Central Eastern  South Eastern Europe
12:00 MediSpend
Topics to be announced soon
12:30 Panel Discussion
Featuring morning speakers
12:50	 Lunch 
hosted by
14:00	 The Talk – Determining Fair Market Value
After an introduction to the topic given by one of our
speakers, participants will have the opportunity to share
their knowledge and experience. Participants will join
a table and become an active part of the discussion at
hand. To get the most out of this interactive session and
format please come prepared to share examples from your
work, share some ideas with your peers, be a part of group
discussions, and, most importantly, participate in active
idea sharing.
	 Fair Market Value considerations: What
does FMV matter?
•	 Scrutiny related to payments to HCPs
•	 Legitimate payments for services
•	 Why does FMV matter?
•	 Current thinking on FMV methodology
•	 How to monitor FMV compliance to mitigate risk of anti-
corruption violations?
•	 FMV Discussions
Milada Brabcova | Eli Lilly
Compliance Director
14:30	 Managing Third-Party Risks – Why it
matters more than ever before
Effective compliance always comes with efficient risk
management. This session will explore how to tackle risks
posed by clients, intermediaries, suppliers, stakeholders and
other third parties and why it is not enough to simply go
through the regulator’s checklist.
•	 How to identify third-party risks in a complex business
environment
•	 Ways to manage third-party risks
•	 True Diligence of potential partners and existing ones
Nicolas Giannakopoulos | Global Risk Profile
Founding Partner
15:00	 Collecting declarations of consent in 
a cross-border environment: Possible
approaches and challenges
Neli Nedkova | Boehringer-Ingelheim
Head of Compliance  Ethics Central and Eastern Europe
15:30	 Data Privacy and consent management
Anthony Papon | Accenture | Managing Director
16:00	 Afternoon tea  networking
Booking line: tel:  +421 257 272 155, fax:  421 255 644 490
email:   lesly.solei@fleming.events, www.fleming.events
CONFERENCE DAY 1 | 24th
February 2016
16:20	 Keynote: EGA – Code of Conduct
for European Generic and Biosimilar 
Medicines Industry
•	 What is the EGA Code of Conduct on Interactions with
HCPs?
•	 What does the EGA Code understand by transparency?
•	 How is the EGA Code going to be implemented?
•	 How is the EGA Code going to be implemented in
countries where ethical codes already exist?
Adrian van den Hoven | European Generic
and Biosimilar Medicines Association - EGA
Director General
16:50	 CASE STUDY: Communication and 
Relationships with HCPs
•	 Optimising interactions with HCPs through a fully
compliant and transparency strategy
•	 Supporting documentation for activities and interactions
with HCPs and HCOs
•	 Managing consent with HCPs
Richard Walters | GlaxoSmithKline
Head of Ethics  Compliance, Pharma Europe
17:20 Speak-Up Culture
Christophe Lesguer | Mylan
Vice President, Chief Compliance Officer Europe
17:50	 SPECIAL DEBATE: Put Yourself in My Shoes
Our speakers from pharma industry and medical
community will get out of the comfort zone by switching
sides and, from an opposed perspective, will present
arguments to support their position in regard to their
relationship and the benefits and the hurdles of disclosure
requirements.
Carin Smand | European Hematology
Association - EHA | Managing Director
18:20	 Evaluation of Day 1  closing remarks 
from the Chair
Speakers and delegates are cordially
invited to attend
a Networking Cocktail Reception
Booking line: tel:  +421 257 272 155, fax:  421 255 644 490
email:   lesly.solei@fleming.events, www.fleming.events
CONFERENCE DAY 2 | 25th
 february 2016
11:00	 Morning coffee  networking
11:20	 Best Practices: Compliance Program 
Structure and Effectiveness
•	 Strengthening the role of compliance within the
organisation
•	 Engaging with leadership to minimise the impact of
regulatory pressures on the achievement of strategic
goals
•	 Implementing strategic changes to manage current
and emerging risks
•	 Fitting anti-corruption and anti-bribery within
existing compliance, legal and other obligations
Tools available to manage internal processes
•	 The role of data collection in identifying risk and
exposures
Marcela Kirberger | Sandoz
Global Compliance Officer
Leonardo Silva | Acino Pharma AG
Head of Compliance
Maria Teresa Rico | Biogen | EU Regional Compliance
Officer and JV Biosimilars Compliance Officer
12:20	 CASE STUDY: Compliance Implications 
and Concerns for Merging Corporate
Cultures
•	 Challenges associated with performing due diligence
and combining compliance processes
•	 How to ensure due diligence post-acquisitions and
mergers
•	 How to align the role of internal compliance teams
in both organisations
KPMG (to be confirmed)
12:50	 Lunch 
hosted by
14:00	 Team Structure is Critical to Success
•	 How to set up a compliance team to deliver on key
objectives of a compliance function
•	 Which capabilities are key for success
•	 Compliance Communication: Make Compliance
a topic for everyone and foster accountability across
the company
Nina Stoeckel | Merck KGaA
Director, Head of Group Compliance Programs LE-CP
14:30	 Third Parties – Organising an Approach 
for Communication, Training and 
Monitoring
•	 Case studies on collaborating with third parties
•	 Which are the most common reasons that third
parties fail to meet your standards for anti-bribery
compliance?
•	 Comparing approaches for large, medium and small
companies
•	 Defining a process for qualifying third parties
•	 Auditing and monitoring programs to ensure
accuracy
•	 Managing third parties: globally, locally or by
headquarters
Paul Melling | Baker  McKenzie
Partner
Karl Boonen | Johnson  Johnson
Senior Director Business Practices and Compliance EMEA
 Canada
15:30	 Q  A Discussion
15:45	 Afternoon tea  networking
9:00	WORKSHOP A
Managing Health Care Professional (HCP)
engagement from needs assessment to 
payments
Moderators:
Neeraj Singhal | MediSpend
Vice President, Product Management and Marketing.
Katie Jacyna | MediSpend | Product Manager
	 Workshop Objectives:
•	 Key aspects and challenges faced by global
companies in engaging HCPs in a multi-country
environment
•	 Identify key players within the company in HCP
engagement process
•	 Managing international HCPs and handling the cross
boarder complexities
•	 Identifying the process, people, and communication
challenges within global organizations
•	 MediSpend’s understanding and approach to solving
this complex problem
9:00	WORKSHOP B
Building an Effective Anti-Corruption 
and Anti-Bribery Program
	 Moderators:
Tim Robinson | MediSpend
Esq., Chief Knowledge Officer / General Counsel
	 Workshop Objectives:
Interactions with third-parties, including agents, distributors,
consultants and others, pose a significant risk to life science
companies. Through this workshop, participants will share
best-practices for building an effective anti-corruption
and anti-bribery program. Through this workshop and
interactive discussion, participants will gain actionable
insights and understand best-practices to benchmark
and improve their existing compliance program.
Topics to be discussed include:
•	 Best practices for selecting and sourcing 3rd parties
•	 Risk based third-party due diligence procedures
•	 Documenting services to be performed and related
terms
•	 Conducting effective training for employees and
3rd parties
Booking line: tel:  +421 257 272 155, fax:  421 255 644 490
email:   lesly.solei@fleming.events, www.fleming.events
16:00	 Conducting Internal Investigations
•	 Establishing an adequate investigation manual
and procedures
•	 Determining how far you should go with your
internal investigation
•	 Step by step internal investigation
Marit Pless | InterMune
European Legal Counsel, Ethical Compliance Director
16:30	 Compliance and Risk Assessment
•	 Shifting from being ‚reactive‘ to risk to being
proactive about managing and mitigating risk and
execution before it becomes an issue
•	 Analysing data and signs to identity and prioritise risks
•	  Anti-corruption and anti-bribery risks: Improving
collaboration between teams to know when red flags
should be raised
•	 Is your anti-bribery policy a discrete, documented
process, or part of a broader policy addressing
various compliance risks?
•	 Company representatives‘ activities – what are the
key areas to address prior to sending personnel into
the field?
Detlef Geiges | AstraZeneca | Head of Corporate
Governance/ Area Compliance Lead DE, AT, CH
17:00	 WRAP UP SESSION:
Attendees will share their findings and will be  given
the opportunity to ask extra questions to speakers.
17:30	 Evaluation of the conference  closing 
remarks from the Chair
17:35	 Farewell Coffee
CONFERENCE DAY 2 | 25th
 february 2016
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For further information please contact:
Dasa Janosikova
Production Manager Life Sciences
Phone No.: +421 257 272 104
Email: dasa.janosikova@fleming.events
Booking line: tel:  +421 257 272 155, fax:  421 255 644 490
email:   lesly.solei@fleming.events, www.fleming.events
OUR SPEAKERS
Adrian van den 
Hoven 
European Generic and
Biosimilar Medicines
Association – EGA, Belgium
Director General
Adrian van den Hoven, joined the
European Generic and Biosimilar
medicines Association (EGA) as a Director
General in September 2013. His priorities
at the EGA are to stimulate competition
in off-patent medicine markets, to foster
market access for generic and biosimilar
medicines, to support policy measures
for sustainable pricing, to promote high
regulatory standards while ensuring that
the associated costs can be integrated
into market dynamics and to develop a
coherent EU industrial strategy to support
the long-term viability of the generic
and biosimilar medicines industry. Prior
to joining the EGA, Adrian van den
Hoven was Deputy-Director General
of BUSINESSEUROPE  where he was
responsible for the International Relations
department, covering trade negotiations
and bilateral relations, and the Industry
department, covering industrial, energy,
environmental and research policy. He
previously worked as an International
Relations researcher and an adjunct
professor in Italy (EUI), France (Nice)
and Canada (Windsor). He obtained his
doctorate in Political Science from the
University of Nice, France in 2000.
Dominique Oliver 
Ahnsehl 
Bayer HealthCare, Germany
Compliance Counsel
Dominique Oliver Ahnsehl
is currently acting as
Compliance Counsel for Bayer
headquartersinGermany.Heisresponsible
for different compliance projects and
acting as legal and compliance support
for the transparency solution of Bayer.
Additionally, he is the business partner
for the EFPIA region and the region Asia
Pacific.
Carin Smand 
European Hematology
Association - EHA,
The Netherlands
Managing Director
Since January 1, 2008 Carin
Smand has been the Managing Director
of the European Hematology Association
(EHA) which has its Executive Office in The
Hague, The Netherlands. EHA, a nonprofit
organization founded in 1992, promotes
excellence in clinical practice, research
and education in European hematology.
Since she has worked for EHA her main
focus has been to further professionalize
the organization by working towards
the development and implementation
of the association’s strategy and policy,
especially in the areas of continuous
medical education, the relationship
with pharmaceutical industry, lobbying
activities, and international collaboration.  
After a 10 year career in accountancy
and tax she worked for 11 years for the
Dutch Health Care Insurance Board as
policy maker and Secretary of various
medical specialty committees, advising
the Minister of Health on the public
health care insurance system. After that
she worked as a national coordinator for
organ and tissue donation for the Dutch
Transplant Foundation.
Carin Smand studied Health Sciences
(policy and strategy) at the University of
Maastricht and Business Economics at
the Hogeschool Amsterdam (Amsterdam
University of Applied Sciences).
Detlef Geiges
AstraZeneca, Germany
Head of Corporate
Governance/Area Compliance
Lead DE, AT, CH
Detlef currently holds
a position of Compliance Area Lead
GE, AT, CH and is responsible for the
compliance leadership in the respective
area and contribution to ECLT and several
regional/global projects. Since 2011, he
became Head of Corporate Governance,
member of SMT  at AstraZeneca, where
he gained extensive experience in
compliance business partnering and
assurance, including compliance support
and advice, maintenance of governance
 assurance framework of monitoring,
auditing, incident management, training,
as well as in financial controls framework
and risk  crisis management.
Detlef started his professional career at
Clinserve Clinical Trial Services in 1996
and joined AstraZeneca Germany Medical
Department in 1998. Between 1998
and 2011, Detlef went through various
positions with increasing responsibilities
in clinical research  operations.
Detlef studied Biology at the University
of Freiburg and completed his PhD in
cellular biology/signal transduction
at German Cancer Research Center,
Heidelber in 1995.
Richard Bergstrom 
European Federation of
Pharmaceutical Industries
and Associations - EFPIA,
Belgium
Director General
Richard Bergström has been the Director
General of the European Federation
of Pharmaceutical Industries and
Associations (EFPIA) since April 2011.
Previously he served for nine years as
the  Director-General of LIF, the Swedish
AssociationofthePharmaceuticalIndustry,
following positions in Switzerland in
regulatory affairs at the pharmaceutical
companies Roche and Novartis. Mr
Bergström was also appointed by the
Swedish Government to the Board of the
Karolinska Institute. He is a pharmacist by
training, receiving his MScPharm degree
from the University of Uppsala, Sweden
in 1988.
Richard Walters 
GlaxoSmithKline, UK
Head of Ethics  Compliance,
Pharma Europe
Dr Richard Walters is Head
of Ethics  Compliance
for Pharma Europe  Canada at
GlaxoSmithKline, based in London. In
his role Richard leads a team of over
70 compliance professionals and is
a member of GSK’s Global Ethics 
Compliance Leadership team. Richard
joined GSK in 2005, following the
completion of his DPhil studies in
Pharmacology at Oxford University,
where he has held roles of increasing
responsibility within RD, Regulatory
Affairs, Scientific Communications,
Medical Affairs, Corporate Strategy
within the CEO’s office and Commercial
Operations; during this time he has been
located in the UK, France, India and
Spain. Richard is a current member of
EFPIA’s Ethics  Compliance Committee,
a certified Leading Professional in Ethics
and Compliance (LPEC) and has an MBA 
from Warwick University Business School.
Booking line: tel:  +421 257 272 155, fax:  421 255 644 490
email:   lesly.solei@fleming.events, www.fleming.events
Karolina
Czernicka-Kuhl 
Novo Nordisk, Poland
Head of Legal and Compliance
Europe East
Karolina Czernicka-Kuhl,
is heading the Novo Nordisk Legal
  Compliance function in Europe East,
covering 17 countries. Prior to joining
Novo Nordisk, Karolina worked for over
12 years at Linklaters (a leading global
law firm) in Warsaw and London focusing
mainly on mergers and acquisitions, as
well as investment funds management.
She holds a master degree in law from the
University of Warsaw, Poland and L.LM
from University of Münster, Germany.
Karolina is an attorney-at-law for Poland
and a solicitor for England and Wales.
Leonardo Silva
Acino Pharma AG,
Switzerland
Head of Compliance
Leonardo Silva heads Acino’s
Compliance department
globally, based out of the company’s
global HQ  in Basel, Switzerland. Prior
to that, Leonardo worked for Takeda
Pharmaceuticals in both Brazil and in
Switzerland’s International hub, covering
the development, implementation
  training on Policies and SOPs in 40+
Emerging Markets.
Prior to Takeda, Leonardo worked for
Merck, Sharp  Dohme (MSD) (formerly
Schering-Plough/Organon) in Brazil and
select LATAM operations such as Central
America, and north South America, as well
as multiple secondments to the global law
department in NJ, USA.
He holds a master degree in law from the
London School of Economics and Political
Science – LSE  - University of London
and is a licensed attorney-at-law for the
jurisdiction of Brazil.
Meltem Ozker 
Gunduz
Novo Nordisk, Turkey
Legal Affairs  Compliance
Director Business Area
Near East (BANE)
Meltem Ozker Gunduz, born in Turkey,
based in Istanbul. Graduated from
Galatasaray University Law Faculty. Her
LL.M studies are ongoing in Istanbul
University with focus on Employment
Law. Worked in Istanbul and London
Offices of Herguner Bilgen Ozeke Attorney
Partnership until 2010, after then joined
Novo Nordisk Business Area Near East in
2010 with responsibility for managing
legal and compliance issues in Turkey,
Iran, Iraq, Israel, Jordan, Lebanon, Syria,
Pakistan, Afghanistan, Ukraine and
Moldova. She is currently Legal Affairs
 Compliance Director in Novo Nordisk
Business Area Near East and she speaks
Turkish, English and French.
Milada Brabcova
Eli Lilly
Compliance Director
Milada Brabcova has been a
Compliance Director for the
Czech Republic and Slovakia
in Eli Lilly since 2007. In
her role she leads an implementation of
the compliance programme with the
main focus on ethical interactions, anti-
corruption and privacy. As a member
of Compliance and Transparency
Working Groups in the Czech and Slovak
Industry Associations (AIFP) she has been
involved in a local implementation of
EFPIA  transparency disclosures. Milada
has 18 years of experience working in
the pharmaceutical industry in several
positions including sales and marketing as
a National Sales Manager, Eli Lilly Czech
Republic. Milada graduated as a Master in
Biology and Chemistry and subsequently
obtained a Doctoral Degree in Natural
Science at Charles University in Prague.
She holds a Master Degree in Business
Administration (MBA) from the Open
University Business School in the United
Kingdom (Milton Keynes).
Marcela Kirberger 
Sandoz, Germany
Global Head of Compliance
Marcela was appointed
Global Head of Compliance
reporting operationally to
Shannon Thyme Klinger and functionally
to Eric Cornut, Chief Ethics, Compliance
and Policy Officer in July of 2014.  Marcela
is based in Holzkirchen, Germany and is a
member of the Sandoz Legal Leadership
Team (SLLT) and the Compliance
Leadership Team (CLT). In this position,
Marcela is responsible for managing and
coordinating all integrity and compliance
matters for Sandoz globally.
Marcela joined Novartis in 2006 and has
worked for different Novartis divisions
since, assuming positions of increasing
responsibility. In 2012, she assumed the
position of Lead Counsel to the Primary
Care and Established Medicines Business
Unit at NPC (Novartis Pharmaceuticals
Corporation) where she provided legal
advice for all BU matters.  Before joining
Novartis, Marcela was a Securities litigator
at Lowenstein Sandler in New Jersey and
prior to that she held a judicial clerkship
for the New Jersey Appellate Division. 
Marcela was born in Buenos Aires,
Argentina and received a law degree from
the Catholic University of Argentina and
later a law degree from the Rutgers School
of Law in Newark, New Jersey.
Milena Yakimova
Actavis, Bulgaria
Director Ethics  Compliance – Central Eastern
 South Eastern Europe
Milena holds a law degree from London
School of economics, Strasbourg
University and a post – graduate degree in
law from College of Europe, Bruges.
Currently Milena is a Director Ethics and
compliance at Actavis with responsibility
for managing the compliance program
within the European region. She has an
experience as a lawyer with the white
collar defense and antitrust practices of
US law firms, based in Brussels. Milena has
extensively advised on the application of
EU competition and regulatory law to the
pharmaceutical sector, on the interplay
between antitrust and intellectual
property law and on how to comply with
the Data Protection Act when transferring
data overseas.   She has also served as a
legal officer at the Bulgarian competition
authority.
Neli Nedkova
Boehringer-Ingelheim, Austria
Head of Compliance  Ethics
Central and Eastern Europe
Dr. Neli Nedkova is
currently Head of
Compliance   Ethics Central and
Eastern Europe. She is responsible for the
implementation of the Group’s corporate
compliance program and development,
implementation and monitoring of the
regional compliance program for the
CEE  Region (19 countries): including
establishing respective governance
structures, performing risk assessment
and due diligence, developing policies
and procedures, performing training
and creating awareness, conducting
program monitoring and internal
investigations. She also coordinates the
network of subject-matter experts and
local compliance officers in the region
and provides guidance and advice to
the management and all functions. She
is a Member of the Global Compliance
Leadership Team and Global Subject
Matter Expert for Anti-corruption.
Booking line: tel:  +421 257 272 155, fax:  421 255 644 490
email:   lesly.solei@fleming.events, www.fleming.events
Nina Stoeckel
Merck KGaA, Germany
Director, Head of Group
Compliance Programs LE-CP
Nina is currently Director
Global Compliance
Program, where she is responsible for
strategicdevelopmentandimplementation
of the effective Compliance program
and organization for all business sectors
of the Merck companies, as well as for
the maintenance of the Compliance
framework and conducting complex
Compliance projects. Between 2009
and 2014, she held variety of positions
with the increasing responsibilities in the
ethics and compliance area at Boehringer
Ingelheim.  Nina started her professional
career in 2000 as an In-house lawyer
and project manager at Media-Group
Suddeutscher Verlag, where she became a
member of the compliance team in 2007.
Nina completed her Law studies at
Ruprecht-Karls-Universitat Heidelberg,
Germany in 1998. In 2008, she gained
her Master of Laws, completing her
postgraduate studies   “International
Business Law” at the University of Applied
Sciences Mainz.
Nicolas
Giannakopoulos
Global Risk Profile,
Switzerland
Founding Partner
Nicolas Giannakopoulos is
an internationally recognized expert in
crime-related issues, including criminal
risks inherent to the public and private
sectors.
After completing a MA  in Political
Science from University of Geneva, Mr.
Giannakopoulos has carried out numerous
research projects on behalf of large
institutions.
He was notably in charge of a three-year
research program on corruption and
organized crime in Switzerland, financed
by the Swiss Confederation.
In 2010, Mr. Giannakopoulos cofounded
Global Risk Profile – a Swiss company
providing Due diligence services.
Lecturer at the University of Geneva, he
is regularly called upon to intervene in
various conferences, some at a ministerial
level.
Paul Melling
Baker  McKenzie
Partner
Paul Melling is an English
solicitor and the founding
partner of Baker 
McKenzie’s Moscow office (he is also
founding partner of the Firm’s Almaty
office).He first joined Baker  McKenzie’s
London office in February 1980, as
a member of the Firm’s East-West
Trade Department, specializing in the
COMECON countries of Eastern Europe
and particularly the USSR.   He took up
residence in Moscow in January, 1989 and
has spent over 27 years as a partner in the
CIS.
Mr. Melling is the founder of and leads
the pharmaceuticals and healthcare
industry practice in Russia/CIS and is
a Steering Committee member of the
Firm’s Global and EMEA Pharmaceuticals/
Healthcare Practice Groups. For 22 years
he has been Honorary Legal Adviser in
Russia to the Association of International
Pharmaceuticals Manufacturers (AIPM).
He has also been the Honorary Legal
Adviser to the British Ambassador in
Moscow since 1990.and is a member of
the Advisory Council of the Russo-British
Chamber of Commerce.  
Mr. Melling also leads the compliance
practice in the Firm’s CIS offices and is a
Steering Committee member of the Firm’s
European Compliance Practice Group. He
is a member of the International Business
Leaders Forum’s International Advisory
Council for Russia and a member of the
Leadership Group for IBLF’s   “Improving
Business Standards in Russia Initiative”.
In 2013 he was appointed to Russia’s B
20 Task Force on Transparency and Anti-
Corruption.
In 2009 Mr. Melling received the
Distinguished Service Award from
AIPM for “Outstanding Contribution
to the Development of the Russian
Pharmaceuticals Market”.
Booking line: tel:  +421 257 272 155, fax:  421 255 644 490
email:   lesly.solei@fleming.events, www.fleming.events

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Corporate Compliance & Transparency in the Pharmaceutical Industry

  • 1. Silver Sponsor: Promotional Sponsor:Lunch Sponsor: www.fleming.events OUR SPECIAL FEATURES • On-Stage Interview with EFPIA • HCP insight • Special debate • Focused discussions KEY BENEFITS OF ATTENDING • Get an update on the implementation of Disclosure Code and the first outcomes and evaluate your implementation process • Unravel compliance challenges relating to data privacy • Define Fair Market Value and develop a consistent, simple and transparent method for your company • Learn how to optimise interactions with HCPs and HCOs through a fully compliant and transparent strategy to obtain consent • Find out compliance implications and concerns for merging corporate cultures • Uncover how to establish an adequate investigation manual and procedures 4th Annual Corporate Compliance & Transparency in the Pharmaceutical Industry 24 - 25 February 2016 Mövenpick Hotel Zürich- Regensdorf, Zürich OUR SPEAKER PANEL Richard Bergstrom EFPIA | Director General Nina Stoeckel | Merck KGaA Director, Head of Group Compliance Programs LE-CP Richard Walters GlaxoSmithKline Head of Ethics & Compliance, Pharma Europe See full speaker panel on the next page GRPTRUE DILIGENCE
  • 2. Media Partners: OUR SPEAKER PANEL Nina Stoeckel | Merck KGaA Director, Head of Group Compliance Programs LE-CP Karl Boonen | Johnson & Johnson Senior Director Business Practices and Compliance EMEA & Canada Marcela Kirberger | Sandoz Global Compliance Officer Christophe Lesguer | Mylan Vice President, Chief Compliance Officer Europe Richard Walters | GlaxoSmithKline Head of Ethics & Compliance, Pharma Europe Detlef Geiges | AstraZeneca | Head of Corporate Governance/ Area Compliance Lead DE, AT, CH Neli Nedkova | Boehringer-Ingelheim Head of Compliance & Ethics Central and Eastern Europe Milena Yakimova | Actavis Director Ethics & Compliance – Central Eastern & South Eastern Europe Meltem Ozker Gunduz | Novo Nordisk Legal Affairs & Compliance Director Business Area Near East (BANE) Marit Pless | InterMune European Legal Counsel, Ethical Compliance Director Leonardo Silva | Acino Pharma AG Head of Compliance Maria Teresa Rico | Biogen EU Regional Compliance Officer and JV Biosimilars Compliance Officer Dominique Oliver Ahnsehl Bayer HealthCare | Compliance Counsel Michiel Lodewijks | Roche | Compliance Officer Richard Bergstrom | European Federation of Pharmaceutical Industries and Associations - EFPIA | Director General Adrian van den Hoven | European Generic and Biosimilar Medicines Association - EGA Director General Carin Smand | European Hematology Association - EHA | Managing Director Milada Brabcova | Eli Lilly | Compliance Director Neeraj Singhal | MediSpend Vice President, Product Management and Marketing Katie Jacyna | MediSpend Product Manager Tim Robinson, Esq. | MediSpend Chief Knowledge Officer / General Counsel Nicolas Giannakopoulos | Global Risk Profile Founding Partner Anthony Papon | Accenture | Managing Director Paul Melling | Baker & McKenzie | Partner KPMG OUR ADVISORY COMMITTEE Esther van Weert F. Hoffmann - La Roche Pharma Healthcare Compliance Leader Europe Gian Luca Trinei Pfizer Chief Compliance Officer Marit Pless InterMune European Legal Counsel Milada Brabcova Eli Lilly, Compliance Director Milena Yakimova Actavis |Director Ethics & Compliance – Central Eastern & South Eastern Europe Hal Glasser Former Senior Director Chief Ethics & Compliance Officer Sanofi Pasteur MSD EVENT INTRODUCTION The past decade have witnessed a wave of global transparency in the pharmaceutical industry, and 2015 has marked the start of a new era in Europe. Companies have exerted to design and implement processes that meet spend transparency and disclosure requirements. From 2016, pharma have to make public its payments to doctors and healthcare organisations in Europe, which is not only a huge technical challenge, but also a major cultural shift. This conference will serve as a platform to discuss compliance and transparency areas of key concern. Do not hesitate, take this great networking opportunity and join us in Zürich! Who will you meet? CxOs, SVPs, Vps, Global heads, Heads, Directors, Officers, Counsels, Managers of Pharma/ Biotech companies responsible for Compliance, Ethics/ Business Ethics, Legal, Regulatory Affairs, Risk Monitoring etc. Representatives of Law firms, Governmental bodies, Audit companies, etc. Supporting Partner: Booking line: tel: +421 257 272 155, fax: 421 255 644 490 email: lesly.solei@fleming.events, www.fleming.events
  • 3. Sponsor: Partner Association:Silver Sponsor: Bronze Sponsor: www.flemingeurope.com 3rd Annual CorPorAte ComPliAnCe & trAnSPArenCy in the Pharmaceutical industry 25th – 26th February 2015, Zürich, Switzerland Swissotel Zurich Our Speaker panel: Julie BOnhOmme, eFpia legal Affairs & Compliance Deputy Director klauS GeldSetzer Santen Chief Compliance officer europe Ole Wendler pederSen nOvO nOrdiSk General Counsel region europe Director legal, Compliance & Business Development nick tyler takeda pharmaceuticalS internatiOnal Director Compliance & Data Privacy milada BraBcOva eli lilly Compliance Director milena yakimOva actaviS Director ethics & Compliance – Central eastern & South eastern europe nader khedr SandOz Head regional Compliance - meA SanGeetha karpOre kumar dr. reddy‘S laBOratOrieS Associate Director, Compliance Head emerging markets tOmaSz kruk mallinckrOdt pharmaceuticalS Director international Compliance eSther van Weert rOche and rOche diaGnOSticS Pharma Healthcare Compliance leader - europe JarOSlav vaSil Bayer healthcare Senior Business Advisor marit pleSS intermune internatiOnal european legal Counsel dan zavOdnick Bayer healthcare llc Corporate Counsel JakuB dvOřáček aiFp (czech aSSOciatiOn OF innOvative pharmaceutical induStry) executive Director rOlF Stahel eurOpean SOciety FOr medical OncOlOGy (eSmO) President timOthy rOBinSOn mmiS inc./ mediSpend Chief Knowledge officer & General Counsel martiJn de kieWit kpmG Head of ethics and Compliance management paul mellinG Baker & mckenzie Partner Geert van GanSeWinkel pOlariS SOlutiOnS managing Director europe Sponsor: Partner Association:Silver Sponsor: Bronze Sponsor: www.flemingeurope.com 3rd Annual CorPorAte ComPliAnCe & trAnSPArenCy in the Pharmaceutical industry 25th – 26th February 2015, Zürich, Switzerland Swissotel Zurich Our Speaker panel: Julie BOnhOmme, eFpia legal Affairs & Compliance Deputy Director klauS GeldSetzer Santen Chief Compliance officer europe Ole Wendler pederSen nOvO nOrdiSk General Counsel region europe Director legal, Compliance & Business Development nick tyler takeda pharmaceuticalS internatiOnal Director Compliance & Data Privacy milada BraBcOva eli lilly Compliance Director milena yakimOva actaviS Director ethics & Compliance – Central eastern & South eastern europe nader khedr SandOz Head regional Compliance - meA SanGeetha karpOre kumar dr. reddy‘S laBOratOrieS Associate Director, Compliance Head emerging markets tOmaSz kruk mallinckrOdt pharmaceuticalS Director international Compliance eSther van Weert rOche and rOche diaGnOSticS Pharma Healthcare Compliance leader - europe JarOSlav vaSil Bayer healthcare Senior Business Advisor marit pleSS intermune internatiOnal european legal Counsel dan zavOdnick Bayer healthcare llc Corporate Counsel JakuB dvOřáček aiFp (czech aSSOciatiOn OF innOvative pharmaceutical induStry) executive Director rOlF Stahel eurOpean SOciety FOr medical OncOlOGy (eSmO) President timOthy rOBinSOn mmiS inc./ mediSpend Chief Knowledge officer & General Counsel martiJn de kieWit kpmG Head of ethics and Compliance management paul mellinG Baker & mckenzie Partner Geert van GanSeWinkel pOlariS SOlutiOnS managing Director europe Past Conferences in Numbers 60% Western Europe 18% Central and Eastern Europe 16% Southern Europe 6% USA GeographicalBreakdownNumberofAttendees Prague 2013 Berlin 2014 Zürich 2015 Very constructive! Very well organised! Group Corporate Governance and Compliance Officer Director, Helsinn Very interesting and useful to hear other companies experience and learn based on this Compliance Manager, GlaxoSmithKline Excellent opportunity to gain knowledge and share experience Deputy Head of Legal Affairs Division, Hemofarm On-Stage Interview The Talk Expert Panels Special Debate Networking Interactive App CONFERENCE FEATURES Booking line: tel: +421 257 272 155, fax: 421 255 644 490 email: lesly.solei@fleming.events, www.fleming.events
  • 4. CONFERENCE DAY 1 | 24th February 2016 8:30 Registration coffee 9:00 Welcoming note from Fleming. 9:05 Opening remarks from the Chair 9:10 On-stage Interview: EFPIA – Update on Implementation of Disclosure Code • Do‘s and don‘ts when implementing EFPIA‘s codes • What‘s going to happen next once the data is disclosed? • What are the challenges anticipated regarding external communication? • What are the challenges in specific countries related to disclosure? Richard Bergstrom | European Federation of Pharmaceutical Industries and Associations - EFPIA Director General 9:40 Transparency Obligations – Examples of Implementation and First Outcomes Transparency obligations are on the rise. The EFPIA Code on Disclosures of Transfers of Value From Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations required reporting starting in 2016 for 2015 spend. • Evaluation of the implementation • A walk through of the practical implementation of transparency processes • Industry first observations after disclosure of data • Country by country differences in central reporting • Progress on managing communication with healthcare professionals Neli Nedkova | Boehringer-Ingelheim Head of Compliance Ethics Central and Eastern Europe Dominique Oliver Ahnsehl | Bayer HealthCare Compliance Counsel 10:30 Morning coffee networking 11:00 Local Perspective: Disclosure and Transparency Lessons Learned Complying with the EFPIA Code on Disclosure of Transfers of Value to Healthcare Professionals and Healthcare Organisations will be a very complex business. This is not least because each of the 33 countries involved has its own slightly different approach to complying with the Code. • Lessons learned from one location can be applied as more associations and countries implement transparency requirements Michiel Lodewijks | Roche | Compliance Officer Meltem Ozker Gunduz | Novo Nordisk | Legal Affairs Compliance Director Business Area Near East (BANE) Milena Yakimova | Actavis | Director Ethics  Compliance – Central Eastern South Eastern Europe 12:00 MediSpend Topics to be announced soon 12:30 Panel Discussion Featuring morning speakers 12:50 Lunch hosted by 14:00 The Talk – Determining Fair Market Value After an introduction to the topic given by one of our speakers, participants will have the opportunity to share their knowledge and experience. Participants will join a table and become an active part of the discussion at hand. To get the most out of this interactive session and format please come prepared to share examples from your work, share some ideas with your peers, be a part of group discussions, and, most importantly, participate in active idea sharing. Fair Market Value considerations: What does FMV matter? • Scrutiny related to payments to HCPs • Legitimate payments for services • Why does FMV matter? • Current thinking on FMV methodology • How to monitor FMV compliance to mitigate risk of anti- corruption violations? • FMV Discussions Milada Brabcova | Eli Lilly Compliance Director 14:30 Managing Third-Party Risks – Why it matters more than ever before Effective compliance always comes with efficient risk management. This session will explore how to tackle risks posed by clients, intermediaries, suppliers, stakeholders and other third parties and why it is not enough to simply go through the regulator’s checklist. • How to identify third-party risks in a complex business environment • Ways to manage third-party risks • True Diligence of potential partners and existing ones Nicolas Giannakopoulos | Global Risk Profile Founding Partner 15:00 Collecting declarations of consent in a cross-border environment: Possible approaches and challenges Neli Nedkova | Boehringer-Ingelheim Head of Compliance Ethics Central and Eastern Europe 15:30 Data Privacy and consent management Anthony Papon | Accenture | Managing Director 16:00 Afternoon tea networking Booking line: tel: +421 257 272 155, fax: 421 255 644 490 email: lesly.solei@fleming.events, www.fleming.events
  • 5. CONFERENCE DAY 1 | 24th February 2016 16:20 Keynote: EGA – Code of Conduct for European Generic and Biosimilar Medicines Industry • What is the EGA Code of Conduct on Interactions with HCPs? • What does the EGA Code understand by transparency? • How is the EGA Code going to be implemented? • How is the EGA Code going to be implemented in countries where ethical codes already exist? Adrian van den Hoven | European Generic and Biosimilar Medicines Association - EGA Director General 16:50 CASE STUDY: Communication and Relationships with HCPs • Optimising interactions with HCPs through a fully compliant and transparency strategy • Supporting documentation for activities and interactions with HCPs and HCOs • Managing consent with HCPs Richard Walters | GlaxoSmithKline Head of Ethics Compliance, Pharma Europe 17:20 Speak-Up Culture Christophe Lesguer | Mylan Vice President, Chief Compliance Officer Europe 17:50 SPECIAL DEBATE: Put Yourself in My Shoes Our speakers from pharma industry and medical community will get out of the comfort zone by switching sides and, from an opposed perspective, will present arguments to support their position in regard to their relationship and the benefits and the hurdles of disclosure requirements. Carin Smand | European Hematology Association - EHA | Managing Director 18:20 Evaluation of Day 1 closing remarks from the Chair Speakers and delegates are cordially invited to attend a Networking Cocktail Reception Booking line: tel: +421 257 272 155, fax: 421 255 644 490 email: lesly.solei@fleming.events, www.fleming.events
  • 6. CONFERENCE DAY 2 | 25th february 2016 11:00 Morning coffee networking 11:20 Best Practices: Compliance Program Structure and Effectiveness • Strengthening the role of compliance within the organisation • Engaging with leadership to minimise the impact of regulatory pressures on the achievement of strategic goals • Implementing strategic changes to manage current and emerging risks • Fitting anti-corruption and anti-bribery within existing compliance, legal and other obligations Tools available to manage internal processes • The role of data collection in identifying risk and exposures Marcela Kirberger | Sandoz Global Compliance Officer Leonardo Silva | Acino Pharma AG Head of Compliance Maria Teresa Rico | Biogen | EU Regional Compliance Officer and JV Biosimilars Compliance Officer 12:20 CASE STUDY: Compliance Implications and Concerns for Merging Corporate Cultures • Challenges associated with performing due diligence and combining compliance processes • How to ensure due diligence post-acquisitions and mergers • How to align the role of internal compliance teams in both organisations KPMG (to be confirmed) 12:50 Lunch hosted by 14:00 Team Structure is Critical to Success • How to set up a compliance team to deliver on key objectives of a compliance function • Which capabilities are key for success • Compliance Communication: Make Compliance a topic for everyone and foster accountability across the company Nina Stoeckel | Merck KGaA Director, Head of Group Compliance Programs LE-CP 14:30 Third Parties – Organising an Approach for Communication, Training and Monitoring • Case studies on collaborating with third parties • Which are the most common reasons that third parties fail to meet your standards for anti-bribery compliance? • Comparing approaches for large, medium and small companies • Defining a process for qualifying third parties • Auditing and monitoring programs to ensure accuracy • Managing third parties: globally, locally or by headquarters Paul Melling | Baker McKenzie Partner Karl Boonen | Johnson Johnson Senior Director Business Practices and Compliance EMEA  Canada 15:30 Q A Discussion 15:45 Afternoon tea networking 9:00 WORKSHOP A Managing Health Care Professional (HCP) engagement from needs assessment to payments Moderators: Neeraj Singhal | MediSpend Vice President, Product Management and Marketing. Katie Jacyna | MediSpend | Product Manager Workshop Objectives: • Key aspects and challenges faced by global companies in engaging HCPs in a multi-country environment • Identify key players within the company in HCP engagement process • Managing international HCPs and handling the cross boarder complexities • Identifying the process, people, and communication challenges within global organizations • MediSpend’s understanding and approach to solving this complex problem 9:00 WORKSHOP B Building an Effective Anti-Corruption and Anti-Bribery Program Moderators: Tim Robinson | MediSpend Esq., Chief Knowledge Officer / General Counsel Workshop Objectives: Interactions with third-parties, including agents, distributors, consultants and others, pose a significant risk to life science companies. Through this workshop, participants will share best-practices for building an effective anti-corruption and anti-bribery program. Through this workshop and interactive discussion, participants will gain actionable insights and understand best-practices to benchmark and improve their existing compliance program. Topics to be discussed include: • Best practices for selecting and sourcing 3rd parties • Risk based third-party due diligence procedures • Documenting services to be performed and related terms • Conducting effective training for employees and 3rd parties Booking line: tel: +421 257 272 155, fax: 421 255 644 490 email: lesly.solei@fleming.events, www.fleming.events
  • 7. 16:00 Conducting Internal Investigations • Establishing an adequate investigation manual and procedures • Determining how far you should go with your internal investigation • Step by step internal investigation Marit Pless | InterMune European Legal Counsel, Ethical Compliance Director 16:30 Compliance and Risk Assessment • Shifting from being ‚reactive‘ to risk to being proactive about managing and mitigating risk and execution before it becomes an issue • Analysing data and signs to identity and prioritise risks • Anti-corruption and anti-bribery risks: Improving collaboration between teams to know when red flags should be raised • Is your anti-bribery policy a discrete, documented process, or part of a broader policy addressing various compliance risks? • Company representatives‘ activities – what are the key areas to address prior to sending personnel into the field? Detlef Geiges | AstraZeneca | Head of Corporate Governance/ Area Compliance Lead DE, AT, CH 17:00 WRAP UP SESSION: Attendees will share their findings and will be given the opportunity to ask extra questions to speakers. 17:30 Evaluation of the conference closing remarks from the Chair 17:35 Farewell Coffee CONFERENCE DAY 2 | 25th february 2016 application Ensure that your time at the conference is effective as well as fun, with our new online easily accessible networking app. Ask questions Vote in polls See the up–to–date agenda View slides in real time and download them Discuss topics via the interactive wall Network with other delegates on-line For further information please contact: Dasa Janosikova Production Manager Life Sciences Phone No.: +421 257 272 104 Email: dasa.janosikova@fleming.events Booking line: tel: +421 257 272 155, fax: 421 255 644 490 email: lesly.solei@fleming.events, www.fleming.events
  • 8. OUR SPEAKERS Adrian van den Hoven European Generic and Biosimilar Medicines Association – EGA, Belgium Director General Adrian van den Hoven, joined the European Generic and Biosimilar medicines Association (EGA) as a Director General in September 2013. His priorities at the EGA are to stimulate competition in off-patent medicine markets, to foster market access for generic and biosimilar medicines, to support policy measures for sustainable pricing, to promote high regulatory standards while ensuring that the associated costs can be integrated into market dynamics and to develop a coherent EU industrial strategy to support the long-term viability of the generic and biosimilar medicines industry. Prior to joining the EGA, Adrian van den Hoven was Deputy-Director General of BUSINESSEUROPE where he was responsible for the International Relations department, covering trade negotiations and bilateral relations, and the Industry department, covering industrial, energy, environmental and research policy. He previously worked as an International Relations researcher and an adjunct professor in Italy (EUI), France (Nice) and Canada (Windsor). He obtained his doctorate in Political Science from the University of Nice, France in 2000. Dominique Oliver Ahnsehl Bayer HealthCare, Germany Compliance Counsel Dominique Oliver Ahnsehl is currently acting as Compliance Counsel for Bayer headquartersinGermany.Heisresponsible for different compliance projects and acting as legal and compliance support for the transparency solution of Bayer. Additionally, he is the business partner for the EFPIA region and the region Asia Pacific. Carin Smand European Hematology Association - EHA, The Netherlands Managing Director Since January 1, 2008 Carin Smand has been the Managing Director of the European Hematology Association (EHA) which has its Executive Office in The Hague, The Netherlands. EHA, a nonprofit organization founded in 1992, promotes excellence in clinical practice, research and education in European hematology. Since she has worked for EHA her main focus has been to further professionalize the organization by working towards the development and implementation of the association’s strategy and policy, especially in the areas of continuous medical education, the relationship with pharmaceutical industry, lobbying activities, and international collaboration. After a 10 year career in accountancy and tax she worked for 11 years for the Dutch Health Care Insurance Board as policy maker and Secretary of various medical specialty committees, advising the Minister of Health on the public health care insurance system. After that she worked as a national coordinator for organ and tissue donation for the Dutch Transplant Foundation. Carin Smand studied Health Sciences (policy and strategy) at the University of Maastricht and Business Economics at the Hogeschool Amsterdam (Amsterdam University of Applied Sciences). Detlef Geiges AstraZeneca, Germany Head of Corporate Governance/Area Compliance Lead DE, AT, CH Detlef currently holds a position of Compliance Area Lead GE, AT, CH and is responsible for the compliance leadership in the respective area and contribution to ECLT and several regional/global projects. Since 2011, he became Head of Corporate Governance, member of SMT at AstraZeneca, where he gained extensive experience in compliance business partnering and assurance, including compliance support and advice, maintenance of governance assurance framework of monitoring, auditing, incident management, training, as well as in financial controls framework and risk crisis management. Detlef started his professional career at Clinserve Clinical Trial Services in 1996 and joined AstraZeneca Germany Medical Department in 1998. Between 1998 and 2011, Detlef went through various positions with increasing responsibilities in clinical research operations. Detlef studied Biology at the University of Freiburg and completed his PhD in cellular biology/signal transduction at German Cancer Research Center, Heidelber in 1995. Richard Bergstrom European Federation of Pharmaceutical Industries and Associations - EFPIA, Belgium Director General Richard Bergström has been the Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA) since April 2011. Previously he served for nine years as the  Director-General of LIF, the Swedish AssociationofthePharmaceuticalIndustry, following positions in Switzerland in regulatory affairs at the pharmaceutical companies Roche and Novartis. Mr Bergström was also appointed by the Swedish Government to the Board of the Karolinska Institute. He is a pharmacist by training, receiving his MScPharm degree from the University of Uppsala, Sweden in 1988. Richard Walters GlaxoSmithKline, UK Head of Ethics Compliance, Pharma Europe Dr Richard Walters is Head of Ethics Compliance for Pharma Europe Canada at GlaxoSmithKline, based in London. In his role Richard leads a team of over 70 compliance professionals and is a member of GSK’s Global Ethics Compliance Leadership team. Richard joined GSK in 2005, following the completion of his DPhil studies in Pharmacology at Oxford University, where he has held roles of increasing responsibility within RD, Regulatory Affairs, Scientific Communications, Medical Affairs, Corporate Strategy within the CEO’s office and Commercial Operations; during this time he has been located in the UK, France, India and Spain. Richard is a current member of EFPIA’s Ethics Compliance Committee, a certified Leading Professional in Ethics and Compliance (LPEC) and has an MBA from Warwick University Business School. Booking line: tel: +421 257 272 155, fax: 421 255 644 490 email: lesly.solei@fleming.events, www.fleming.events
  • 9. Karolina Czernicka-Kuhl Novo Nordisk, Poland Head of Legal and Compliance Europe East Karolina Czernicka-Kuhl, is heading the Novo Nordisk Legal   Compliance function in Europe East, covering 17 countries. Prior to joining Novo Nordisk, Karolina worked for over 12 years at Linklaters (a leading global law firm) in Warsaw and London focusing mainly on mergers and acquisitions, as well as investment funds management. She holds a master degree in law from the University of Warsaw, Poland and L.LM from University of Münster, Germany. Karolina is an attorney-at-law for Poland and a solicitor for England and Wales. Leonardo Silva Acino Pharma AG, Switzerland Head of Compliance Leonardo Silva heads Acino’s Compliance department globally, based out of the company’s global HQ in Basel, Switzerland. Prior to that, Leonardo worked for Takeda Pharmaceuticals in both Brazil and in Switzerland’s International hub, covering the development, implementation   training on Policies and SOPs in 40+ Emerging Markets. Prior to Takeda, Leonardo worked for Merck, Sharp Dohme (MSD) (formerly Schering-Plough/Organon) in Brazil and select LATAM operations such as Central America, and north South America, as well as multiple secondments to the global law department in NJ, USA. He holds a master degree in law from the London School of Economics and Political Science – LSE - University of London and is a licensed attorney-at-law for the jurisdiction of Brazil. Meltem Ozker Gunduz Novo Nordisk, Turkey Legal Affairs Compliance Director Business Area Near East (BANE) Meltem Ozker Gunduz, born in Turkey, based in Istanbul. Graduated from Galatasaray University Law Faculty. Her LL.M studies are ongoing in Istanbul University with focus on Employment Law. Worked in Istanbul and London Offices of Herguner Bilgen Ozeke Attorney Partnership until 2010, after then joined Novo Nordisk Business Area Near East in 2010 with responsibility for managing legal and compliance issues in Turkey, Iran, Iraq, Israel, Jordan, Lebanon, Syria, Pakistan, Afghanistan, Ukraine and Moldova. She is currently Legal Affairs Compliance Director in Novo Nordisk Business Area Near East and she speaks Turkish, English and French. Milada Brabcova Eli Lilly Compliance Director Milada Brabcova has been a Compliance Director for the Czech Republic and Slovakia in Eli Lilly since 2007. In her role she leads an implementation of the compliance programme with the main focus on ethical interactions, anti- corruption and privacy. As a member of Compliance and Transparency Working Groups in the Czech and Slovak Industry Associations (AIFP) she has been involved in a local implementation of EFPIA transparency disclosures. Milada has 18 years of experience working in the pharmaceutical industry in several positions including sales and marketing as a National Sales Manager, Eli Lilly Czech Republic. Milada graduated as a Master in Biology and Chemistry and subsequently obtained a Doctoral Degree in Natural Science at Charles University in Prague. She holds a Master Degree in Business Administration (MBA) from the Open University Business School in the United Kingdom (Milton Keynes). Marcela Kirberger Sandoz, Germany Global Head of Compliance Marcela was appointed Global Head of Compliance reporting operationally to Shannon Thyme Klinger and functionally to Eric Cornut, Chief Ethics, Compliance and Policy Officer in July of 2014. Marcela is based in Holzkirchen, Germany and is a member of the Sandoz Legal Leadership Team (SLLT) and the Compliance Leadership Team (CLT). In this position, Marcela is responsible for managing and coordinating all integrity and compliance matters for Sandoz globally. Marcela joined Novartis in 2006 and has worked for different Novartis divisions since, assuming positions of increasing responsibility. In 2012, she assumed the position of Lead Counsel to the Primary Care and Established Medicines Business Unit at NPC (Novartis Pharmaceuticals Corporation) where she provided legal advice for all BU matters.  Before joining Novartis, Marcela was a Securities litigator at Lowenstein Sandler in New Jersey and prior to that she held a judicial clerkship for the New Jersey Appellate Division.  Marcela was born in Buenos Aires, Argentina and received a law degree from the Catholic University of Argentina and later a law degree from the Rutgers School of Law in Newark, New Jersey. Milena Yakimova Actavis, Bulgaria Director Ethics Compliance – Central Eastern  South Eastern Europe Milena holds a law degree from London School of economics, Strasbourg University and a post – graduate degree in law from College of Europe, Bruges. Currently Milena is a Director Ethics and compliance at Actavis with responsibility for managing the compliance program within the European region. She has an experience as a lawyer with the white collar defense and antitrust practices of US law firms, based in Brussels. Milena has extensively advised on the application of EU competition and regulatory law to the pharmaceutical sector, on the interplay between antitrust and intellectual property law and on how to comply with the Data Protection Act when transferring data overseas. She has also served as a legal officer at the Bulgarian competition authority. Neli Nedkova Boehringer-Ingelheim, Austria Head of Compliance Ethics Central and Eastern Europe Dr. Neli Nedkova is currently Head of Compliance   Ethics Central and Eastern Europe. She is responsible for the implementation of the Group’s corporate compliance program and development, implementation and monitoring of the regional compliance program for the CEE Region (19 countries): including establishing respective governance structures, performing risk assessment and due diligence, developing policies and procedures, performing training and creating awareness, conducting program monitoring and internal investigations. She also coordinates the network of subject-matter experts and local compliance officers in the region and provides guidance and advice to the management and all functions. She is a Member of the Global Compliance Leadership Team and Global Subject Matter Expert for Anti-corruption. Booking line: tel: +421 257 272 155, fax: 421 255 644 490 email: lesly.solei@fleming.events, www.fleming.events
  • 10. Nina Stoeckel Merck KGaA, Germany Director, Head of Group Compliance Programs LE-CP Nina is currently Director Global Compliance Program, where she is responsible for strategicdevelopmentandimplementation of the effective Compliance program and organization for all business sectors of the Merck companies, as well as for the maintenance of the Compliance framework and conducting complex Compliance projects. Between 2009 and 2014, she held variety of positions with the increasing responsibilities in the ethics and compliance area at Boehringer Ingelheim. Nina started her professional career in 2000 as an In-house lawyer and project manager at Media-Group Suddeutscher Verlag, where she became a member of the compliance team in 2007. Nina completed her Law studies at Ruprecht-Karls-Universitat Heidelberg, Germany in 1998. In 2008, she gained her Master of Laws, completing her postgraduate studies “International Business Law” at the University of Applied Sciences Mainz. Nicolas Giannakopoulos Global Risk Profile, Switzerland Founding Partner Nicolas Giannakopoulos is an internationally recognized expert in crime-related issues, including criminal risks inherent to the public and private sectors. After completing a MA in Political Science from University of Geneva, Mr. Giannakopoulos has carried out numerous research projects on behalf of large institutions. He was notably in charge of a three-year research program on corruption and organized crime in Switzerland, financed by the Swiss Confederation. In 2010, Mr. Giannakopoulos cofounded Global Risk Profile – a Swiss company providing Due diligence services. Lecturer at the University of Geneva, he is regularly called upon to intervene in various conferences, some at a ministerial level. Paul Melling Baker McKenzie Partner Paul Melling is an English solicitor and the founding partner of Baker McKenzie’s Moscow office (he is also founding partner of the Firm’s Almaty office).He first joined Baker McKenzie’s London office in February 1980, as a member of the Firm’s East-West Trade Department, specializing in the COMECON countries of Eastern Europe and particularly the USSR. He took up residence in Moscow in January, 1989 and has spent over 27 years as a partner in the CIS. Mr. Melling is the founder of and leads the pharmaceuticals and healthcare industry practice in Russia/CIS and is a Steering Committee member of the Firm’s Global and EMEA Pharmaceuticals/ Healthcare Practice Groups. For 22 years he has been Honorary Legal Adviser in Russia to the Association of International Pharmaceuticals Manufacturers (AIPM). He has also been the Honorary Legal Adviser to the British Ambassador in Moscow since 1990.and is a member of the Advisory Council of the Russo-British Chamber of Commerce. Mr. Melling also leads the compliance practice in the Firm’s CIS offices and is a Steering Committee member of the Firm’s European Compliance Practice Group. He is a member of the International Business Leaders Forum’s International Advisory Council for Russia and a member of the Leadership Group for IBLF’s “Improving Business Standards in Russia Initiative”. In 2013 he was appointed to Russia’s B 20 Task Force on Transparency and Anti- Corruption. In 2009 Mr. Melling received the Distinguished Service Award from AIPM for “Outstanding Contribution to the Development of the Russian Pharmaceuticals Market”. Booking line: tel: +421 257 272 155, fax: 421 255 644 490 email: lesly.solei@fleming.events, www.fleming.events