www.epharmaday.org

Thursday, May 31st, 2018

Copenhagen

Engvej 171

Copenhagen, Denmark

Park Inn by Radisson Copenhagen Airport Hotel

Event managed by

Clinical research 2.0Strategic, organizational, infrastructuraland quality aspects

Il Vaso di FioriMichela Rimondini e Monia Dardi

Taking part in the event, you support

“The Vase of Flowers” project

Sponsored by:

What is the evolution of skills, processes and tools in pharmaceutical companies, CROs and research centers, also in view of the regulatory changes taking place?

What organizational changes will we implement to adapt to a new environment, and which are the priority areas?

How will the healthcare technology evolution influence the way of doing clinical research?

What is the point of view of investigators/physicians, study nurses, research coordinators and data managers working in this sector who are experiencing this transformation?

ABOUT

The Scientific Board

Who should attend?

Representatives of Pharmaceutical and Biotechnology companies, Clinical Research Organizations, Academic centers,

Hospital Centers, and Clinical Technology companies. Especially Clinical Research Professionals, belonging to the

following departments:

www.epharmaday.org

Event managed by

Will lead a panel of experts to share best practices, knowledge and experience in this field.

Jesper Kjær

Manager for the IMPACT, portal and eTrials support department

within Clinical Systems, Data and Trial Management (CSDTM),

Clinical Operations at Novo Nordisk A/S

Martin Holm-PetersenCEO at Insife

• Clinical Research and Development

• Quality Assurance

• Regulatory

• Pharmacovigilance

• Clinical Operations

• Statistics and Data Management

• Information Technology

• Market Access

Official language: EnglishClinical research 2.0Strategic, organizational, infrastructural, and quality aspects

Nordic ePharma Day

The world of clinical research is in a phase of profound transformation.

The acceleration of scientific knowledge in recent years is leading to an exponential increase in the number of clinical trials

with new drugs. This increase in studies is associated with a profound methodological transformation.

To ensure rapid access to patients for new drugs and to contain high development costs, regulatory authorities, FDA and

EMA, show a readiness to accept new approaches ranging from new experimental designs, to early access models, to ma-

nagement of some aspects of the development with a “risk based” approach, up to the opening of the future use of Real

Word Evidence data.

In this context, the operators involved in the management of clinical research are facing new important challenges.

AGENDA

www.epharmaday.org

Event managed by

Official language: English

Clinical research 2.0Strategic, organizational, infrastructural, and quality aspects

Nordic ePharma Day

09:00 - 09:30 Registration and welcome coffee

09:30 - 09:40 Welcome from the Chair

Martin Holm-Petersen - CEO at Insife

Jesper Kjær - Manager for the IMPACT, portal and eTrials support department within Clinical Systems, Data and

Trial Management (CSDTM), Clinical Operations at Novo Nordisk A/S

09:40 - 10:10 Rasmus Nelund - Vice President at NNIT

Digitizing Drug Development: How Much Can It Save?

10:10 - 10:40 Jakob Wested - Post Doc in CeBIL at University of Copenhagen

Governing prospects, navigating minefields and protecting interests - Legal issues in big data driven biotech & biomedical innovation

10:40 - 11:10 Coffee break

11:10 - 11:40 Chris Hamilton - Director at CROS NT

Tony Hewer - Principal, Global Compliance & Strategy at Medidata Solutions Inc.

Adhering to data privacy and data transparency requirements - how technology and service providers can support sponsors

11:40 - 12:10 Vincent Laulagnet - Principal Delivery Lead Think Big Analytics at Teradata

Creating Value with Big Data the Clinical trials research area. From the proof of concept to operationalization

12:10 - 13:10 Networking Lunch

13:10 - 13:40 Inge Hansen - Director, Centralised Monitoring Unit at Novo Nordisk

Risk Based Monitoring - Why is that much broader than traditional monitoring?

13:40 - 14:10 Karen Kiilerich - Special Legal Consultant at The Danish Council on Ethics and National Committee

on Health Research Ethics

Lene Grejs Petersen - M.Sc.Pharm, Senior Adviser at Danish Medicines Agency, Medicines

Licensing & Availability, Clinical Trials

Clinical Trials Regulation: Preparation for the future in Denmark

14:10 - 14:40 Karina Markersen - Senior Network Manager at NEXT - National Experimental Therapy Partnership

NEXT partnership: a public-private partnership to make Denmark a prefered country for clinical trials

14:40 - 15:10 Coffee break

15:10 - 15:40 Mitchell Silva - CEO at Esperity

Patient engagement during drug development: why, how and what?

15:40 - 16:10 Valdo Arnera - Scientific Advisor and General Manager at ERT Geneva

What have we learnt about future eClinical Technology Adoption in Clinical Trials from the implementation of eDiaries and how does it help to predict the future?

16:10 - 16:40 Vittoria Reggiani - Clinical Process Manager at OPIS

Implementation of new Technologies: Complexity, Speed and Quality of Data - Lessons Learned

16:40 - 16:50 Conclusions

Nordic ePharma Day SPONSORS

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Event managed by

Engvej 171 - Copenhagen, Denmark

Park Inn by Radisson Copenhagen Airport Hotel

HOW TO REACH THE CONFERENCE VENUE

For further information

Please visit the conference website or contact the organisational offices:

Stefania Sarga Phone +39 (0)35.4123594 | stefania.sarga@LSacademy.it

www.epharmaday.org

Event managed by

SPONSORSHIP

OPPORTUNITIES

Situated near both the Copenhagen Airport and the city centre, the Park Inn is an ideal

place to stay while traveling for business and leisure. If you arrive by car, this hotel’s

location in Copenhagen, Denmark provides free parking. The nearby metro and train

stations are convenient for cyclists and guests without cars.

Transport options

Metro station Femøren (two stops to airport and six to city centre) - beside hotel

Copenhagen International Airport - 3 km (5 min by metro)

Copenhagen Central Station - 7 km (10 - 15 min by car)

For further information, please visit the website

Sponsor the event and take the chance to network with all attendees!

Exclusive benefits and high impact branding

before, during and after the conference.

Download the Events Summary 2018

Two ways to register

Date Signature

The fee includes: seat at the conference, copy of presentations of Speakers who

allow the distribution, informative literature for the day, networking lunch, coffee

break, organisational office assistance, certificate of attendance.

€ 655,00 Early Bird fee extended until Friday, May 25th, 2018

€ 765,00 Ordinary fee (after Friday, May 25th, 2018)

€ 570,00 Patronage members fee (Association )

€ 430,00 Academy, Public Administration, Freelance

(please, specify )

€557,00 Special offer for past events delegates

For any additional information, please contact:

Stefania Sarga

Terms of payment The registration fee must be paid at the time of registration. Confirmation of event admission will be given on receipt of payment. EasyB reserves the right to refuse late registra-

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stefania.sarga@LSacademy.it Phone: +39 (0)35.4123594