The leading event for all parties involved in the clinical trials market in CEE

17 - 18 April 2018

Conference Agenda - Day 1

Day 1


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Registration and Morning Coffee

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Opening Comments from the Organisers and the Chairperson

Chairperson: Dr Vladimir Misik, Board Member at SanaClis, Founder & Partner at LongTaal sro

Session 1: Keynotes Day 1

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KEYNOTE 1: The Global Landscape of Clinical Trials

A review of the current landscape of global clinical trials and perspectives of the CEE and its differentiators. Insights into trends and predictions as well as growth drivers that attract business to the region. Global factors that will affect clinical trials in the CEE and measures to strengthen its competitive advantage.

Vladimir Misik
Board Member, SanaClis, Founder & Partner

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KEYNOTE 2: Industry Perspective: Novo Nordisk

Our industry keynotes will share the company’s current plans for clinical trials in the CEE. Global data as well as specific cases will be discussed and the future outlook for clinical trials from a multinational perspective will also be revealed.

Joanna Nagorska
Lead Regional Trial Manager for Europe East
Novo Nordisk, Poland
Karolina Szulc
Clinical Operations Manager for Europe East
Novo Nordisk, Poland

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Coffee & Networking Break (with an opportunity for conversations and discussion)
Session 2: Regulations with CEE Focus

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Presentations Followed by a Discussion

Hear country insights and regulatory updates impacting trials in the CEE. Speakers will address the impact of regulations in specific countries as well as the:

  • Impact of GDPR enforcement
  • Impact of national requirements on trial delivery
  • Impact of regulations on timelines for trial delivery
  • Guidelines impacting patient recruitment for trials

Discussion: Your Trial, Your Questions!

Have your say and ask our speakers about what’s on your mind.

Topics include:

  • The impact of upcoming regulations on trials
  • Challenges of new regulations on multi-country trials
  • Medical reform in the CEE
  • Future predictions of clinical trial global shifts and emerging opportunities
  • Challenges of implementing the Clinical Trial Directive
Piotr Drobek
Deputy Director of the Social Education and International Department
GIODO, Poland
Czech Republic
Lucie Kravackova
Chief of Clinical Department
SUKL - State Institute for Drug Control, Czech Republic
Konstantin Kachulev
BADI (Bulgarian Association of Drug Information)
Kamen Doxev
BACR (Bulgarian Association of Clinical Research)
Beata Cecetkova
Clinical Research Director
TWMA Clinical Research and Pharmacovigilance, Czech Republic
Ottó Skorán
MD, President of Board, MCRN Hungary and Chief Executive Officer
Svabhegy Paediatric Hospital

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Panel Discussion: Unifying the CEE

In this panel discussion speakers will return to the stage and assess the idea of developing a single unified body for CEE clinical trial regulations and best practice. Questions include:

  • Current initiatives and new ideas.
  • The benefits, drawbacks and issues.
  • Who is best placed to manage and lead this?
  • What would it take to deliver?
  • What impact would this have on current practice?

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Lunch and Networking
Session 3: Regulations in Practice

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Interpretation of the EU 2016/679 Data Protection Regulation

The use of personal data is vital to ensure quality and reliability in trials and research. The regulation EU 2016/679 is to be enforced in May 2018. Its main objective is to harmonise the rules for protecting participants privacy when processing health data, genetic data and biometric data. This session shares the main key facts for industry to adapt their practices and ensure compliance to the law.

Piotr Drobek
Deputy Director of the Social Education and International Department
GIODO, Poland

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The Impact of the EU 2016/679 on Clinical Research

Understanding the modern meaning of personal data (new categories, definitions and main principles like privacy by design, privacy by default and limited purpose rule) and its application to clinical trials practice will be addressed. Specific details on:

  • Data processing (processes & rights)
  • Transfer of data outside the EU
  • Pseudonymisation/anonymization of data
  • The role and function of Data Protection Officers (DPO)
  • Joint Controllers responsibility
  • Right to data portability and the right to be forgotten
Karol Szczukiewicz
Regional Study Manager
Roche, Poland

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Preparing to Implement ICH GCP E6 (R2)

Join our speaker to find out how the ICH GCP E6 (R2) will impact clinical trials in the CEE. Details on the requirements that are related to third party oversight, as well as collection and maintenance of source documents will be shared.

Ingrid Klingmann
MD, PhD, Chairman
The European Forum for Good Clinical Practice (EFGCP)

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Meeting the Regulatory Safety Surveillance of Drugs in Clinical Trials

Pharmaceutical sponsors work proactively with all stakeholders to ensure an optimal approach to safety monitoring of drugs in trials. Preparing good risk management plans and assessments and training of the personnel are key to regulatory compliance. Find out what comprehensive and innovative approaches are applied to accumulate data from the discovery and preclinical clinical stages at Eli Lily.

Patrick Brossard
Principal Clinical Pharmacologist
Eli Lilly and Company, Switzerland

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Coffee & Networking Break (with an opportunity for conversations and discussion)
Session 4: Case Studies Followed by a Discussion

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Case Study 1: Successful Inspection Readiness: Preparation, Practice and Study Case

Regulatory inspectors are knocking at your door - are you ready? Listen to practical advice on how to be prepared for inspections at any time. Read the study case to gain insight into new perspectives on inspection readiness to improve your clinical operations for guaranteed success. Learn how to implement quality and compliance for inspection readiness of your trials.

Oleksii Mikheiev
MD GmbH, Germany

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Spotlight Session: Clinical Trials Using Radio-tracers – A New Opportunity for All Stakeholders

CEE may at last bring the medicine of tomorrow to today’s patients in the growing area of radiopharmaceuticals for PET imaging and therapeutics. With over 200 clinical trials requiring cyclotron produced radio-tracers conducted in Western Europe, Synektik with its GMP cyclotron facility in Warsaw, has launched the service for providing traditional and innovative PET-tracers in CEE.

In this spotlight session the speaker will present new opportunities for all stakeholders and provide details of their R&D facility in Warsaw currently being used to supply radio-tracers for clinical trials in CEE.

Eytan Oppenheim
International Business Development
Synektik S.A., Poland

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Case Study 2: Delivering Clinical Trials for Medical Devices

Hear the details of the ISO141155 clinical investigation of medical devices and how this will affect medical device trials. Hear first-hand how other organisations have successfully implemented the directive to deliver trials for medical devices.

Ramón López
Clinical Research Manager
Thrombotargets Europe
Session 5: New Partnership Models

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Round Table: Creating New Site Partnership Models

A partnership collaboration between CROs and sites are essential to the success of a trial. This round table presents a new model of partnerships between IQVIA and investigators in clinics and hospitals. Known as the Prime Site Partnership, two case studies will be demonstrated on the model and panel members will assess how these partnerships have evolved.

Chaired by Gjon Mirdita, Head of Site Management, Key Markets, R&D Solutions NEMEA & CESE, IQVIA

Gjon Mirdita
VP, Clinical Operations, R&D Solutions
Leanne Magne
VP, Clinical Operations, R&D Solutions
Gorazd B. Stokin
MD, Ph.D., FAAN, Chair at International Clinical Research Center, Translational Ageing and Neuroscience Program, Centre for Translational Medicine; International Clinical Research Centre
St. Anne’s University Hospital, Czech Republic
Mikhail V. Dvorkin
MD, PhD, Surgical Oncologist, Director
The Centre For International Clinical Trials, Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary, Russia

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Closing Remarks and Close of Day 1
Gjon Mirdita
VP, Clinical Operations, R&D Solutions

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Cocktail & Networking Reception
For Speaker Opportunities Please Contact: Dr Tahira Rashid; Tel: +44 20 800 45 694