corporate compliance & transparency - fleming · tomasz kruk, vifor pharma group, switzerland...

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22nd & 23rd February 2018 Renaissance Zurich Tower Hotel, Zurich

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Corporate Compliance & Transparency in the Pharmaceutical Industry

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Multi -stakeholder debate

GDPR workshop

Disclosure experience

Effective ABAC programs

Your prestigious speaker panelLeonor Pimenta PissarraNovartis, PortugalChief Legal Officer & Country Compliance Head

Adrian van den HovenMedicines for Europe, Belgium General Director

Maike BermuellerBoehringer Ingelheim, GermanyGlobal Healthcare Compliance Officer

Caitriona RyanGlaxoSmithKline, IrelandEthics & Compliance Director Europe

Ana Bayo BustaMenarini, SpainHead of Legal Affairs and Compliance

Mihaela ScarlatescuA&D Pharma, RomaniaHead of Legal and Compliance

Michael de VilliersRoche, SwitzerlandHealthcare Compliance Lawyer

Marc-Olivier LamaroValeant Pharmaceuticals – Bausch + Lomb, FranceVice President Corporate Compliance

Jan GeisslerEUPATI, GermanyDirector

Ananda PlateMyeloma Patients Europe, BelgiumCEO

Thomas RothBoehringer Ingelheim, GermanyGlobal Data Privacy Officer

Karl BoonenJ&J, Belgium Senior Director Business Practices & Compliance

Russell BarrIpsen, UKGlobal Ethics & Compliance Director

Carmelo PerroneAstraZeneca, ItalyCompliance Business Partner

David FinkBelgium formerly Head, Global Compliance Policies, Standards & Practices at Teva

Sarah Harris SteingrüberTransparency International, UKProgramme Manager Pharmaceuticals & Healthcare Programme

Jürg Granwehr scienceindustries, SwitzerlandHead of Pharma Department

Julienne JamesonEwopharma Group, IrelandGroup Legal Counsel, Deputy Group Compliance Officer

Arielle HungMerckgroup, GermanyCompliance Counsel

Tomasz KrukVifor Pharma Group, Switzerland Head of Compliance

Bella Rafael HovhannisyanCSL Behring, SpainCompliance Director Intercontinental Commercial OperationsMember of ETHICS

Saskia LangnickelNovartis, SwitzerlandGlobal Governance & Process Lead Spend Transparency Program

Guglielmo TrovatoCatania University, Policlinico di Catania, ItalyChief Physician, Clinical Professor of Internal Medicine

www.fleming.events tel.: +421 257 272 155 email: [email protected]

Key topics GDPR implementation – practical guidelines

effective ABAC programs

Compliance in patient engagements

Digitization and practical aspects of HCP interactions & the role of medical liaisons

Third-party due diligence

Disclosure experience & leveraging transparency data

Compliance monitoring & risk identification

Compliance culture & its measurement

embedding corporate compliance into business

Infusing ethics into compliance

Keys for distributor compliance & transparency

Key takeaways: The changing role of medical liaisons and ethical

interactions with HCPs

new anti-bribery & anti-corruption standards

Transparency driven by law vs disclosure code

Updates for the next reporting period

Third-party compliance - red flags in due diligence

How to create and follow risk maps

Utilizing transparency data for business

Measures to retain trust as an industry

Managing compliance & transparency in one simple system

Compliance model for multinationals and small or mid-size companies

Special features

Group exercise led by patient speakers

Dilemma debate on entrepreneurial approach vs corporate compliance

Pre-conference workshop on GDPR implementation

Best practices from big pharma, small pharma and distributors

Report from Transparency International

Updates from Medicines for Europe

Welcome keynote by scienceindustries


2017 Conference In Numbers

Participants

Speakers

Days

Hours in the Program

Participating Countries

Hours of networking

111

31

2

17

21

10

Testimonials How Did the Delegates Benefit?“Very informative, with a lot of practical examples from industry and patients.”

Marina Relly, Newport Pharmaceuticals, Ireland

“I enjoyed very much the part of the congress that I attended and I believe you are totally on the right direction. Fleming has a good reputation among compliance professionals so keep it that way.” Efi Gkika, Baxter, Switzerland

“I think this was a fantastic event, providing for a great opportunity not only to learn but also to network. I truly enjoyed it.” Karolina Czernicka Kuhl, Novo Nordisk, Poland

“Reflected on current industry issues in a pragmatic way, with knowledgeable speakers.” Savvas Palaistis, UCB, Greece

“This is my first compliance event which I enjoyed immensely, especially networking & hearing experience from others in the industry.” Daniel Reddy, Shire, Switzerland

of the attendees would recommend the event to their colleagues

of the attendees intend to attend next year

of attendees appreciated the many networking opportunities

90%

73%

91%


Who should attend:Vice Presidents, Heads, Officers, Managers, General Counsels:

Data Protection/Privacy Data Governance Compliance & Transparency

Legal, IT/IS, Security IT Compliance Data Controller/Processor

GDPR Workshop21st february 2018

14:00 Registration & coffee

14:30 Opening remarks from the workshop leader

14:40 Data privacy concerns and use of health data

Outlining challenges and workshop goals

KEY TOPICS:

•new data privacy laws around the globe •GDPr and the eU-US Privacy Shield framework •new roles & responsibilities of data processors

and controllers•Managing data privacy in transparency

disclosure•operationalizing a data privacy compliance

program•risk mapping and risk-based approach

15:40 Coffee break

16:10 Group work

17:10 Presentation of outcomes:

•Best practices to manage transparency reporting while complying with data privacy laws

•Understanding the impact of the GDPr on international transparency reporting

•Best practices for GDPr assessments and upcoming audits – how to build frameworks and timelines for complying with data privacy laws

17:50 Wrap-up and closing remarks from the workshop leader


DAY 122nd february, 2018

8:30 Registration & morning coffee

9:00 Welcoming note from Fleming.

9:05 Opening remarks from the chair

9:10 WELCOME KEyNOTE by scienceindustries: Transparency development – tackling the present, shaping the future

•Implementation of disclosure code in Switzerland

•Self-regulation vs. legislation – compliance gaps and future development

•Critical insights into consent rates and local strategies

Jürg Granwehr, scienceindustries, SwitzerlandHead of Pharma Department

9:20 Rooting out corruption in the pharmaceutical & healthcare sector

•Managing conflicts of interest•Standardising codes of conduct in emerging

markets•Latest projects & lessons learned

Sarah Harris Steingrüber, Transparency International, UK, Programme ManagerPharmaceuticals & Healthcare Programme

9:40 Leveraging transparency data

•expectations on data analysis•Utilizing data for business•How to share data with management to foster

compliance

Saskia Langnickel, Novartis, SwitzerlandGlobal Governance & Process Lead Spend Transparency Program

10:30 Morning coffee & networking

11:00 SPOTLIGHT SESSION: The impact of new EU data privacy rules Case study and debate featuring pharmaceutical companies preparing to comply with the new regulation

How to turn GDPR readiness into a success•Key success factors when implementing new

GDPr requirements•opportunities to foster a pro-active data privacy

management •Challenges & possible solutionsThomas Roth, Boehringer Ingelheim, GermanyGlobal Data Privacy OfficerDebate:•Interpretation & local implementation of the

new eU data protection regulation•Defining new roles •Practical aspects of implementation – examples

of tools, approaches and systems•GDPr: Privacy by design, the small company

experience

Caitriona Ryan, GlaxoSmithKline, Ireland, Ethics & Compliance Director Europe

Julienne Jameson, Ewopharma Group, IrelandGroup Legal Counsel, Deputy Group Compliance Officer

Thomas Roth, Boehringer Ingelheim, GermanyGlobal Data Privacy Officer

12:30 Luncheon

plus VIP Board Room Lunch (by invitation only)


DAY 122nd february, 2018

14:00 SPOTLIGHT SESSION: Third-party due diligence

After the two case study presentations, the participants will have the opportunity to share their knowledge and experience in the following discussion. 1. How to ensure third party adherence to company requirements•Why third party due diligence is important?•What are the key aspects of an effective due

diligence process?•Due diligence as multi-function process. What

functions shall be involved?•Tools vs. human approach. Shall we rely only on

automated due diligence?

Bella Rafael Hovhannisyan, CSL Behring, SpainCompliance Director Intercontinental Commercial Operations, Member of ETHICS

2. Effective approaches to managing third-party compliance•red flags in due diligence•Mitigation of third-party risks•examples, experience and learnings

Karl Boonen, J&J, Belgium, Senior Director Business Practices & Compliance

PAnELISTS:

Marc-Olivier Lamaro, Valeant Pharmaceuticals – Bausch + Lomb, France, Vice President Corporate Compliance

Tomasz Kruk, Vifor Pharma Group, Switzerland Head of Compliance

Karl Boonen, J&J, Belgium, Senior Director Business Practices & Compliance

Bella Rafael Hovhannisyan, CSL Behring, SpainCompliance Director Intercontinental Commercial Operations, Member of ETHICS

15:10 Afternoon tea & networking

15:40 Group exercise: Interactions between industry and patients

Interactive session led by patient speakers•Update on the project•Legal agreements – case study•Major steps forward

Jan Geissler, EUPATI, Germany, Director

Ananda Plate, Myeloma Patients Europe, Belgium, CEO

16:40 CASE STUDIES by Roche & Merckgroup

Industry Interactions with Patient Groups and Patients – a new compliance landscape or not?•Legitimate rights for interacting with Patient

Groups and Patients•review of selected compliance provisions •orphan disease areas

Michael de Villiers, Roche, SwitzerlandHealthcare Compliance Lawyer

Compliance in patient engagements•optimizing interactions in a highly regulated

environment•Patient centricity•next steps

Arielle Hung, Merckgroup, Germany, Compliance Counsel

17:10 SPOTLIGHT SESSION: Embedding compliance into business

After the two case study presentations, the participants will have the opportunity to share their knowledge and experience in the following dilemma debate•entrepreneurial approach vs. corporate compliance•Achieving business excellence without

compromising risks and compliance•examples & steps forward

Leonor Pimenta Pissarra, Novartis, PortugalChief Legal Officer & Country Compliance Head

Carmelo Perrone, AstraZeneca, ItalyCompliance Business Partner

18:10 Wrap-up and closing remarks from the chair


DAY 223rd february, 2018

8:30 Registration & morning coffee

9:00 Opening remarks from the chair

9:05 KEyNOTE: Medicines for Europe disclosure preparation – an update

•Medicines for europe report•final preparations before the first disclosure

in 2018•Addressing gaps and tackling challenges

Adrian van den Hoven, Medicines for Europe, Belgium, General Director

9:35 SPOTLIGHT SESSION: Effective ABAC programs

After the three case study presentations, the participants will have the opportunity to share their knowledge and experience in the following discussion.•Anti-bribery policy development: issues and

approaches•Best practices in current anti-bribery programs•new principles•Lessons learned

David Fink, Belgium, formerly Head, Global Compliance Policies, Standards & Practices at Teva

Ana Bayo Busta, Menarini, Spain, Head of Legal Affairs and Compliance

Tomasz Kruk, Vifor Pharma Group, Switzerland Head of Compliance

10:50 Morning coffee & networking

11:20 SPOTLIGHT SESSION: Best practices in compliance monitoring and risk identification

•After the two case study presentations, the participants will have the opportunity to share their knowledge and experience in the following discussion.

•effective risk identification & monitoring programs – examples & experience.

•How to create and follow risk maps•Automation of processes in compliance and

transparency monitoring•Managing compliance and transparency in one

simple system – ideal or reality?•Utilizing reporting tools – internal vs external

Case study: Compliance Investigations

Russell Barr, Ipsen, UK, Global Ethics & Compliance Director

12:20 PANEL DISCUSSION

Big data challenges

12:40 Luncheon

13:40 SPOTLIGHT SESSION: Practical aspects of the industry – HCP interaction & communication featuring HCPs/HCOs and industry speakers

•Digitization of HCP interactions•Sponsor/HCP/HCo best practices•Transparency & ethical principles•future expectations•Dos and Don'Ts in HCP relationship management

Maike Bermueller, Boehringer Ingelheim, Germany, Global Healthcare Compliance Officer

Guglielmo Trovato, Catania University, Medical Unit of Diagnostica e Terapia Medica of the University Hospital – Policlinico di Catania, Italy, Chief Physician, Clinical Professor of Internal Medicine


DAY 223rd february, 2018

14:30 CASE STUDy: Embedding a TRUST culture in pharmaceutical organisations

Practical session on how GSK have worked and continue to work in embedding a VALUeS culture of trust, respect for patients, integrity & transparency in the organisation

Caitriona Ryan, GlaxoSmithKline, Ireland Ethics & Compliance Director Europe

15:00 Afternoon tea & networking

15:30 CASE STUDy: by a small company: Strategic compliance - attempting to satisfy everyone

•Start simple. Usher in and allow absorption•ensure responsibility is shared between

management and colleagues•Use your contractual partners colleagues for

shared experiences•embrace audits. That’s how we improve•resources may not need to be full-time

– employees might wear two hats

Julienne Jameson, Ewopharma Group, Ireland Group Legal Counsel, Deputy Group Compliance Officer

16:00 Keys for distributors compliance & transparency

•How to combine partners requirements (efPIA and non-efPIA)

•Being transparent – a second nature•risks moved from producer to distributor

Mihaela Scarlatescu, A&D Pharma, RomaniaHead of Legal and Compliance

16:30 Wrap-up and closing remarks from the chair

I would like to thank everyone who has helped with the research and organization of this event, especially the speakers, for their support and commitment.

Dasa Janosikova, Production Manager Life [email protected]


Darius Slavik | MD, Corporate Learning Programs

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Terms and Conditions:1. PAYMenT TerMS. Fleming Events, s.r.o. (hereinafter as “fe”) requires the full payment of the invoiced amount within 7 working days

from the issue date of the invoice. fe reserves the right to refuse entry to any client who does not pay the invoice in full and on time. If the payment is not received on fe’s account on the seventh day from the date of the issue of the invoice, fe is entitled to charge the Client an overdue interest of 5% p.a. for every day, for which the Cleint’s payment is overdue. The registration fee includes: conference documentation, admission to all conference sessions, lunches and refreshments, admission to networking social breaks during the event. The registration fee does not include: travel, hotel accommodation, transfers or insurance.

2. HoTeL ACCoMMoDATIon. overnight accommodation is not included in the registration fee. A reduced rate may be available for fe’s clients at the hotel hosting the event. The reservation form will be sent to the client after the venue has been confirmed, but no later than one month before the event begins.

3. CAnCeLLATIon BY CLIenT. The client has the right to cancel his/her participation in the event. Cancellation must be received by fe in writing, either by mail, email or fax. If the client cancels with more than one month’s advance notice before the start of the event, fe shall be entitled to retain and charge 50% of the total invoiced amount. If the client cancels with one month’s (or less) advance notice, or fails to attend the event, then the client shall not be entitled to any refund nor any discount. Client’s failure to attend the event does not cancel, decrease or in any matter waives the client’s obligation to fully pay the fee invoiced to the client by fe.

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6th Annual Corporate Compliance & Transparency 22nd & 23rd february 2018 | Zurich

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