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

17 - 18 April 2018

InterContinental Warszawa Hotel

Conference Agenda - Day 1

Day 1

08:30

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Registration and Morning Coffee
09:20

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Opening Comments from the Organisers and the Chairperson
Session 1: Keynote Addresses Day 1
09:30

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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.

10:00

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KEYNOTE 2: New EU Regulations and Compliance Updates

Analysis of the latest regulatory initiatives and compliance updates impacting clinical trials in Europe today. Results from the impact of Brexit on European trials and insight into the preparations for the implementation of the European data protection law

Francis Crawley
Executive Director
Good Clinical Practice Alliance - Europe (GCPA), Belgium
10:30

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Regulatory Q & A

Topics that will be discussed include:

  • The impact of upcoming regulations on trials
  • Challenges of new regulations on multi-country trials
  • Medical reform in practice
  • Future predictions of clinical trial global shifts and emerging opportunities
11:00

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Coffee & Networking Break (with an opportunity for conversations and discussion)
Session 2: Regulations with CEE Focus
11:30

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Regulations with CEE Focus

CEE insights from those working in country share updates and practices for national requirements. Details of the latest national regulations and initiatives will be shared by experts in clinical trials.

  • Preparation for GDPR enforcement
  • Impact of national regulations on timelines for trial delivery
  • National guidelines impacting patients for trials

Ask the experts: Your trial your questions!

  • Challenges of implementing the Clinical Trial Directive
  • Regulatory issues impacting your trial
  • The impact of upcoming regulations on trials
  • Challenges of new regulations on multi-country trials
Piotr Drobek
Deputy Director of the Social Education and International Department
GIODO, Poland
Ottó Skorán
MD, President of Board, MCRN Hungary and Chief Executive Officer
Svabhegy Paediatric Hospital
Lucie Špatenková
Clinical Operations Manager
CRC s.r.o. Czech Republic
13:00

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Lunch and Networking
Session 3: Regulations in Practice
14:30

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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
15:00

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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
15:30

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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)
16:00

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Coffee & Networking Break (with an opportunity for conversations and discussion)
Session 4: Case Studies
16:30

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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
Verum.de GmbH, Germany
17:00

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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: Panel Discussion: Multi-Country and Multi-Site Trials
17:30

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Panel Discussion: Multi-Country and Multi-Site Trials

Representatives from the site, the sponsor and the CRO share their expertise on multi-site and multi-country trials.

  • Delivering multinational trials
  • Developing international cooperation for clinical trials
  • Multi-site trial issues
  • Management of multi-site trials
  • How to effectively disseminate experience between sites
Karol Szczukiewicz
Regional Study Manager
Roche, Poland
Oleksii Mikheiev
MD
Verum.de GmbH, Germany
Ramón López
Clinical Research Manager
Thrombotargets Europe
18:00

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