COMPLIANCE & TRANSPARENCY EXCELLENCE IN LIFE SCIENCES

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Event info

Amsterdam, The Netherlands

26th - 27th, September

Compliance Industry

Conference Summary

EuroEvents is pleased to invite you to the inaugural edition of the Compliance and Transparency Conference for Life sciences, on 26th and 27th of September 2019 in Amsterdam, The Netherlands.

As heavy regulated industry, the companies are facing ever changing regulatory requirements. The industry players endeavour to better design and implement, assess and improve their programs to drive compliance into the Corporate DNA. Putting in place a holistic compliance program requires building a state-of-the-art programs and practices, taking care of the all aspects of industry codes and regulatory requirements.

The new technologies promise to offer imminent value for the industry, at the same time pose challenge of adoption and adaptation of the existing programs and practices. The general shift towards these technologies is conditional on the robust evidence and understanding of the benefits their adoption. Nonetheless, industry leaders and early adopters have been testing and already put in place some of these solutions in their everyday operations.

Therefor, our Conference will give recognition to the best practices and offers a platform for open discussion and exchange of ideas on how to overcome the present-day challenges compliance professionals the life sciences industry are facing.  Benefit from the learning, benchmarking and networking opportunities and adapt the best practices to your company specific needs.

Join us in very new home of the European Medicines Agency for a remarkable experience!

Speakers and experts

Hear from the leading professionals and experts and learn how they are coping with the challenges in the industry

Detlef Geiges

Company:
Astra Zeneca

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Position:
Senior Director Compliance Assurance, Global Methodology & Europe & Russia/Eurasia Lead

Company:
Astra Zeneca

Country:
Germany

Liesbeth Bergmans

Company:
Teva Pharmaceuticals

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Position:
General Counsel EU Commercial

Company:
Teva Pharmaceuticals

Gabor Sulyok

Company:
Novartis

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Position:
Head of Compliance

Company:
Novartis

Martine Zimmermann

Company:
Alexion Pharma

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Position:
Global Head of Regulatory affairs

Company:
Alexion Pharma

Daniel Schafaghi

Company:
Boehringer- Ingelheim

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Position:
Head of Global Compliance Program and Regions Management

Company:
Boehringer- Ingelheim

Country:
Germany

Natacha Udo-Beauvisage

Company:
Servier

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Position:
Global Data Protection Officer

Company:
Servier

Tetiana Isaieva

Company:
Roche

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Position:
, Head of Compliance EEMEA and Indian Subcontinent

Company:
Roche

Aleksej Daineko

Company:
LEO Pharma

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Position:
Head of Global Compliance & Risk Business Partnering

Company:
LEO Pharma

Ariadna Quesada

Company:
AbbVie

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Position:
Ethics and Compliance Officer

Company:
AbbVie

Julien Durand

Company:
IFPMA Future Health Technologies Commission (invited)

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Position:
Executive Director Compliance Amgen & Chair

Company:
IFPMA Future Health Technologies Commission (invited)

Thomas Pfennig

Company:
Bayer, invited

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Position:
Global Head of compliance

Company:
Bayer, invited

Agenda

Agenda Learn the latest trends in the industry

08:30 - 09:00
Speaker:
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Registration & Morning Refreshments

08:30 – Registration & Morning Refreshments 

09:00 – Opening remarks from the Chairman

09:00 - 10:30
Speaker: Martine Zimmermann, Tetiana Isaieva,
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Session I: Latest updates on the regulatory landscape

09:00  –  09:30 Overview of the global landscape

Martine Zimmermann, Global Head of Regulatory affairs, Alexion Pharma

09:30  –  10:00 Life Science Risk Strategies in VUCA world

  • How to build a strong risk culture through effective risk positioning
  • New and rising Risks…or…Opportunities
  • Risk appetite: balancing of value creation and value protection

Tetiana Isaieva, Head of Compliance EEMEA and Indian Subcontinent, Roche

10:00  –  10:30 MDR & IVDR: Challenges and best practices

10:30 - 11:00
Speaker:
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Networking Break
11:00 - 12:30
Speaker: Aleksej Daineko
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Session II: Culture of continuous improvement: Specific aspects of the compliance programs

11:00  –  11:30 Culture of integrity: Balance between value-driven and control-based compliance.

Aleksej Daineko, Head of Global Compliance & Risk Business Partnering, LEO Pharma

 

11:30  –  12:30 Panel Discussion: Compliance culture and values as a competitive advantage

  • The role of the board in building compliance culture
  • Challenges of incorporating culture and corporate values in the DNA of the Company
  • How to deal with cultural differences across world?
12:30 - 14:00
Speaker:
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Lunch Break
14:00 - 15:30
Speaker: Daniel Schafaghi, Detlef Geiges
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Session III: From reactive to strategic approach: Building a holistic compliance program

14:00  –  14:30 Build and maintain global readiness to address compliance risks with flexibility

Daniel Schafaghi, Head of Global Compliance Program and Regions Management, Boehringer- Ingelheim

14:30  –  15:00 The (D)Art of Assurance

  • Global vs. regional vs. local Monitoring
  • Depth of Assurance
  • Use of Data Analytics
  • Adaptive, risk-based Monitoring
  • Learning from Darts

Detlef Geiges, Senior Director Compliance Assurance | Global Methodology & Europe & Russia/Eurasia Lead, Astra Zeneca

15:00  –  15:30 Improved training programs and adoption of e-learning Tools

15:30 - 16:00
Speaker:
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Networking Break
16:00 - 17:30
Speaker: Gabor Sulyok
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Session IV: Effective transparency programs as competitive advantage

16:00  –  16:30 Transparency in Disclosure of Payments and other Transfers of Values – considerations, challenges and best practices

– Global transparency snapshot

– EFPIA – new Code of Practice

– Key considerations in practice (roles and responsibilities, controls and monitoring, etc.)

– Key challenges (data privacy, outsourcing, etc.)

Gabor Sulyok, Head of Compliance, Novartis

 

16:30  –  17:30 Panel Discussion: Transparency: Beyond money transfers

  • Sponsorships and conferences participation
  • Patient-data interactions data availability & more
17:30
Speaker:
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END OF CONFERENCE DAY I

End of Day I

Summary and Conclusions

08:30 - 09:00
Speaker: /
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Registration & Morning Refreshments

08:30 – Registration & Morning Refreshments 

09:00 – Opening remarks from the Chairman

09:00 - 10:30
Speaker:
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Session V: Tech giants and start-ups: A new market landscape

09:00  –  09:30 Overcome barriers for innovation: regulatory, HR, financial

09:30  –  10:00 Competition landscape: Mergers & acquisitions in EU competition law

10:00  –  10:30 The impact of tech giants penetrating the market – what should be expected?

10:30 - 11:00
Speaker:
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Networking Break
11:00 - 12:30
Speaker: Natacha Udo-Beauvisage
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Session VI: Disruptive innovation: Application and challenges of emerging technologies

11:00  –  11:30 Manage the emerging technological risk: Overcome the challenges of adoption of cutting edge technologies

11:30  –  12:00 Unlock the possibilities of big data and ensuring data protection

  • further useof data
  • scientific research as compatible use
  • patients expectations on further use
  • transparency

Natacha Udo-Beauvisage, Global Data Protection Officer, Servier

 

12:00  –  12:30 Blockchain for Compliance and Transparency

  • Traceability within the supply chain,
  • Consent and clinical trial management
  • Real time red flags
12:30 - 14:00
Speaker:
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Networking Lunch
14:00 - 15:30
Speaker: Ariadna Quesada
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Session VII: Managing a patient-centric ecosystem: Third parties & more

14:00  –  14:30 Interactions with patients and patient organisations

14:30  –  15:00 Dealing with challenges of patient support programs

Ariadna Quesada, Ethics and Compliance Officer, AbbVie

15:00  –  15:30 Panel Discussion: Prevention over interventions: Effective ABAC programs

15:30 - 16:00
Speaker:
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Networking Break
16:00 - 17:30
Speaker: Liesbeth Bergmans
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Session VIII: Forethoughts on Compliance and Transparency

16:00  –  16:30 Social media as a rising compliance issue

  • Setting the stage
  •  Legal framework regarding Social Media Use
  • Do’s and Don’ts

Liesbeth Bergmans, General Counsel EU Commercial, Teva Pharmaceuticals

16:30  –  17:30 Continuous improvement of skills and competences among the Compliance professionals

17:30
Speaker:
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END OF CONFERENCE

Summary and Recap of the Conference

End of Conference

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