Corporate Compliance & Transparency in Pharma Zurich

1. www.flemingeurope.com
3rd Annual
Corporate
Compliance
& Transparency
in the Pharmaceutical Industry
25th – 26th February 2015, Zurich, Switzerland
Who will you meet?
Ethics and Compliance Officers General Counsel
Vice Presidents and Directors of:
Corporate Responsibility
International Contracts
Corporate Compliance
Legal Affairs
Internal Audit
Business Conduct
Transparency Operations
Private practice lawyers specialising in:
Corporate Governance
International Regulation & Compliance
White Collar Crime
Investigations
Life Sciences
Pharmaceuticals
What will you hear about?
EFPIA disclosure requirements
Change Management - How to prepare your team for
transparency
Defining a transparency framework: Local vs. regional vs.
global
The human side of compliance: communication, training
and talent management
How to prevent corruption in your organisation
The challenges in emerging markets and their impact in
Europe
Review tools and techniques for assessing risk posed by third
parties
For further information please contact:
Cristina Mendoza / Senior Conference Producer
Phone No.: + 421 257 272 193
Email: cristina.mendoza@flemingeurope.com
Our Speaker Panel:
Richard Bergström
EFPIA, Director General
Katrín Fjeldsted, CPME
(Comité Permanent des
Médecins Européens -
Standing Committee of
European Doctors)
President
Kersten Schmahl
Actavis, Vice President,
Ethics & Compliance Europe
and MEAAP
Klaus Geldsetzer, Santen
Chief Compliance Officer Europe
Ole Wendler Pedersen
Novo Nordisk, General Counsel
Region Europe Director Legal,
Compliance & Business Development
Swee Kheng Khor, AbbVie
Associate Director Office of Ethics
and Compliance Middle East and
Pakistan
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
Compliance Officer
Stephen Nguyen-Duc
Abbvie Europe, Office of Ethics
& Compliance Director TBC

2. www.flemingeurope.com
Our Expert Advisory Board:
Klaus Geldsetzer
Chief Compliance Officer
Europe
Santen (Germany)
Milada Brabcova
Compliance Director
Eli Lilly (Czech Republic)
Swee Kheng Khor
Associate Director Office of
Ethics and Compliance
Middle East and Pakistan
AbbVie (United Arab
Emirates)
Gian Luca Trinei
Chief Compliance Officer
Pfizer (Italy)
Jörg von Manger-
Koenig, Executive Vice
President Legal and
Compliance & Group
General Counsel, Nobel
Biocare (Germany)
Hal Glasser
Former Senior Director Chief
Ethics & Compliance Officer
Sanofi Pasteur MSD
(France)
Event Introduction
Transparency requirements are taking on global dimensions.
There has been a push for public transparency over the past
decade of interactions between the pharmaceutical and life
sciences industries and healthcare professionals and organisations.
Government authorities and voluntary self-regulatory industry
groups assert that enhancing the transparency of these interactions
will promote compliant behavior and thus mitigate potential
conflicts of interest. Transparency and disclosure requirements
have generally been country-specific, focusing primarily on
payments and transfers of value to HCPs and HCOs licensed
by or located within a specific country. However, the industry
has begun to develop initiatives to harmonize transparency and
disclosure requirements across geographic borders.
This conference will serve as a platform to discuss compliance
and transparency areas of key concern. Discuss with leading
speakers disclosure requirements, do‘s and don‘ts when
defining a transparency framework, how to prevent corruption,
the challenges in emerging markets, how to monitor third
parties, etc. Do not hesitate, take this great networking
opportunity and join us in Zürich!
For further information please contact:
Cristina Mendoza / Senior Conference Producer
Phone No.: + 421 257 272 193, Email: cristina.mendoza@flemingeurope.com

3. email: robert.markus@flemingeurope.com, www.flemingeurope.com
Booking line: tel: +36 1 411 1929, fax: +36 1 411 1841
Day 1 | 25th February 2015
8:30 Registration coffee
9:00 Welcoming note from Fleming Europe
9:05 Opening remarks from the Chair
9:10 EFPIA – Disclosure Requirements
• Analysing best practice to maintain the EFPIA code
leading up to 2016
• What has the feedback been so far?
• Enhancing cooperation to achieve transparency
• Expected impact on future relationships with HCPs and
on the industry
Richard Bergström, EFPIA, Director General
9:40 What the Pharma Industry Really Had to Do When
Getting Ready for Transparency
• From concept to practice – the actual impact on the
industry
• Communication approaches to professional societies
and/or public to explain transparency requirements
• Reporting obligations for companies
• Obtaining consent for disclosure of data from HCPs
• What to do if consent is not obtained?
Ole Wendler Pedersen, Novo Nordisk
General Counsel Region Europe Director Legal,
Compliance & Business Development
10:10 Morning coffee & networking
10:40 The ‚Customer‘ Perspective and their Concerns -
HCPs/HCOs and the Disclosure Requirements
• How does the medical community perceive the code?
• What obligations are imposed on HCPs with regards to
reporting?
• What is the impact in the medical community?
Katrín Fjeldsted, CPME (Comité Permanent des Médecins
Européens - Standing Committee of European Doctors)
President
11:10 The Legal Perspective – The Challenges of Data
Protection
The EFPIA Code has raised data protection issues as HCP
names and affiliations are recognised as personal data,
and, throughout Europe, data protection laws set out
roughly the same conditions regarding the use of personal
data. In this session we will take a closer look at the
interaction of transparency and data protection rules in
Europe and address what steps pharmaceutical companies
need to take to ensure they remain compliant.
11:40 Transparency Driven by Legislation
• Distinguishing between the EFPIA transparency code as
a “voluntary scheme” and specific legal obligations
• How business models have changed jurisdictions
impacted by transparency legislation
• What new ways of cooperation have emerged between
industry and HCPs?
12:30 Lunch
13:30 BRAINSTORMING SESSION – Defining your
Transparency Vision: Local vs. Regional vs. Global
To boost interactivity and networking, the audience
will break into smaller groups. Each table will have the
opportunity to discuss for 30 minutes the different
approaches and weigh the do‘s and don‘ts when defining
a strategy to address transparency.
• What are the do‘s and don‘ts when implementing local,
regional, or global approaches to transparency?
• What is right level of governance, collaboration and
visibility in terms of HCP/HCO spend across the EU?
• Wich country-specific compliance policies and privacy
laws would influence tracking and reporting cross-border
spend?
14:30 Change Management: Establishing a Compliant
and Ethical Culture
Organisational change directly affects all departments
from the entry level employee to senior management. The
entire company needs to learn how to handle changes
to the organisation. Research, surveys and experience
have shown that much, if not most, of the resistance to a
change can be eliminated through appropriate action:
• How to implement change management to achieve
compliance
Sangeetha Karpore Kumar, Dr.
Reddy‘s Laboratories, Associate Director
Compliance Head Emerging Markets
15:00 Setting Up an Effective Anti-Corruption
and Anti-Bribery Programme
• Determining whether your programme works in
practice
• Establishing cohesive reporting mechanisms
• Which functions in the organisation should be involved
to help mitigate corruption risks?
• Determining the most appropriate compliance
structure: centralised vs. local/regional
• The role of data collection in identifying risk and
exposures
15:30 Afternoon tea & networking
16:00 The Rare but Far-reaching Whistleblower:
A Tool to Detect Corruption
• Internal vs. third party alert line solutions
• Privacy and whistleblower programmes
• When should you respond to the whistle being blown
internally?
• Establishing an adequate investigation manual and
procedures
• Cooperation with the authorities
16:30 Analysing Best Practices to Establish a Compliance
Road-Map
• Strengthening communication from top to bottom
• Optimising collaboration between compliance and
other departments
• What are the tools available to manage internal
processes?
• How to ensure that compliance is a powerful and
respected partner for the business
• Training best practices to cope with the current
environment
17:00 Compliance as a Developing Discipline in Europe
• Compliance as a developing discipline in Europe
• What makes a good compliance officer? What are the
requirements?
• Empowering the role of the compliance officer
to embed compliance effectively within business
operations
• How do you train your own compliance officers?
Tomasz Kruk, Mallinckrodt Pharmaceuticals
Director International Compliance
17:30 Closing remarks from the Chair
Speakers and delegates are cordially invited to attend a
Networking Cocktail Reception

4. email: robert.markus@flemingeurope.com, www.flemingeurope.com
Booking line: tel: +36 1 411 1929, fax: +36 1 411 1841
Day 2 | 26th February 2015
9:00 Welcoming note from the Chair
9:10 Outside the Box Presentation: Lessons for the
Pharmaceutical Industry
What can the industry learn from other industries‘
compliance programmes? E.g. tobacco, mining,
banking, etc.
9:40 Best Practices for Managing and Monitoring
Third Parties
• Evaluation and monitoring activities to confirm Third
Parties’ compliance with the required standards
• Determining what information and due diligence is
required according to the type of third party
• Assessing our third party‘s awareness of corruption
and other risks and company‘s compliance practices
Nader Khedr, Sandoz
Head Regional Compliance – MEA
10:10 Handling Third Parties‘ Risk
• What are the strategies and tools available to assess
risk?
• What are the high risk third parties?
• What are the warning signs in the cooperation with
third parties?
Kersten Schmahl, Actavis
Vice President, Ethics & Compliance - Europe and MEAAP
10:40 Morning coffee & networking
11:10 Enhancing Collaboration with Third Parties
• Building partnerships with third parties that are able
to meet your requirements
• Support each other through the dissemination of
knowledge, expertise, teaching and mentoring
11:40 The Cross-Border Effects of Bribery and
Corruption Legislation
• Extraterritorial application of US law and UK Anti-
Bribery law in other countries and regions
• Key regions targeted when investigating pharma
companies
• What is the profile of a company at risk?
12:40 Lunch
13:40 Bridging Regions: Europe and Emerging
Markets
• Overcoming cultural challenges in cross-border
implementation of a compliance programme
• Key legislative provisions in the region that need to
be considered
• Enhancing cooperation to evaluate and manage risk
operations
14:10 Spotlight Session: Compliance & Transparency
in Emerging Markets
An opportunity for experts to share their
knowledge and experience with peers from
different emerging regions and to discuss the
challenges in managing corruption, risks and
third parties.
• Overview of political, legal and regulatory
approaches
• Understanding the local approach when it comes to
corruption
• How to handle the key challenges in the region
• How to shape the external environment into an
appropriate corruption-free climate for doing
business
• What are the strategies for dealing with unreliable
and inaccessible third parties in foreign jurisdictions?
• How can you conduct effective due diligence on
third parties in emerging markets?
• Understanding and investigating red flags in order to
avoid improper payments
• How can you ensure that your monitoring
programme has local relevance and efficacy?
Swee Kheng Khor, AbbVie,
Associate Director Office of Ethics and Compliance Middle
East and Pakistan
Sangeetha Karpore Kumar, Dr.
Reddy‘s Laboratories, Associate Director
Compliance Head Emerging Markets
15:40 Q & A session
15:55 Closing remarks from the Chair
16:00 Farewell Coffee and Networking
I would like to thank everyone who provided assistance
with the research and organisation of this event,
especially our expertadvisers and speakers.
Cristina Mendoza, Conference Producer
+ 421 257 272 193, cristina.mendoza@flemingeurope.com