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Programme Hints

1st Morning Session on 26 February 2018, 11:05 – 13:00

Clinical Trials Regulation 536/2014

Moderators: Dagmar Chase and Ulrike Lorch

The “coming into effect” of the EU Clinical Trials Regulation 536/2014 is approaching, despite delays. A number of supplementary guidelines have been published in EudraLex Volume 10 and the EU Portal is being worked on feverously.

Stakeholders are making progress in getting ready and also in identifying areas of benefits and concerns. This session will provide a perfect platform for stakeholders’ views as we are moving along and gaining more insight in the new processes and procedures. Many Member States have started – and some even finalized - their local implementation of areas where the Regulation leaves room for the Member States.

EMA, industry and academic sponsors, as well as Ethic Committees and patients will be represented in this session expressing their perception – good and bad – of Regulation 536/2014.
A lively discussion following the presentations is guaranteed - don’t miss this session…

1st Afternoon Session on 26 February 2018, 14:30 – 17:00

Risk Based Quality Management

Moderator: Michèle Garot

Risk based approach is a one of the key drivers to optimise quality in Clinical Trials. This requires an adequate design and plan, an engagement of all parties, Sponsor and Investigator and an alignment with regulatory expectations. In order to properly tackle such a complex topic, 3 brilliant European experts who will join our conference in Vienna: a Pharmaceutical Sponsor, member of Transcelerate, an Investigator, the European representative of the Society of Clinical Research sites, and the Head of the GCP inspectorate of a major National Competent Authority, all on stage to update you with current practices and perspectives.
Last but not least, a 4th expert will present the value of computerised Clinical Trials as a modern way to gain quality.
If the implementation of risk based models still poses questions, if you look for direction, solutions and want to understand danger zones, join us in Vienna on 26 and 27 February

1st Parallel Session on 27 February 2018, 08:30 – 10:30

GCP compliance of e-Systems and Technical Solutions
Outcome of an EMA workshop on this complex subject in June, 2017

Moderator: Alan Yeomans

The adoption of new technologies in clinical research remains complex raising numerous questions and issues with limited guidance being available.

The EMA GCP Inspectors Working Group has recently taken the initiative of inviting industry representatives to a workshop to discuss issues arising from the adoption of new technologies in clinical research.

  • What are the problems?
  • What is the consensus between regulators and the industry on what should be done to alleviate them?
  • Where is there still work to be done?

EuCROF had the privilege to be invited and contribute to this working forum; the key highlights of this meeting will be presented during the session.

2nd Parallel Sessions on 27 February 2018, 11:00 – 12:30

Medical Devices

Moderator: Dr. Antoinette van Dijk

The European Medical Device Regulation is bringing significant changes from the Directives it is replacing. The new EU Medical Device Regulation (MDR 2017/745) was published in May 2017 and the clock of the 3-year mandatory transitional period has started since then. The year 2020 to be fully compliant with the Regulation is not far away and it is easy to lose precious time to get ready.

Transition from the directives to the Regulation will require considerable changes to be created and implemented by the Notified Bodies and Manufacturers.

In this session you will be able to listen to the General Highlights on this new European Medical Device Regulation, followed by the impact assessment of a large manufacturer describing how and when a Manufacturer needs to adapt and approach these changes.

Closing finally the Medical Device session with a more in-depth overview on what a Clinical Evaluation Report needs to contain.

Data Protection

Moderator: Isabelle Abousahl & Thierry Lepoutre

The emergence of patient centric approaches, digital strategies, as well as responsible data sharing policies, has generated a new issue: to protect sensitive personal data while maximising its value for innovation.

As part of the plenary session, light will be shed on the value for patients, as well as for companies, of the new EU data protection framework.

Would you like to hear how to approach an effective General Data Protection Regulation (GDPR) implementation?

Then join us for a dedicated breakout session where you could meet with experts and colleagues, and consolidate your views on some key matters, such as:

  • Taking into account the clinical trial sites’ experience, to help you setting up GDPR compliant Clinical Trial Agreements
  • Adapting your GDPR implementation to an innovative and global environment
  • Implementing de-identification standards to support secondary uses of clinical data

1st Afternoon Session on 27 February 2018, 13:30 – 15:30

Peri and post-approval research environment in 2020:  Boldly shaping the future while not going overboard of this shaken ship!

Moderator: Xavier Fournie

Peri and post-approval research environment is challenging, quickly evolving and has limited secure global gold standards.
Late phase research requires anticipation and agility, regulatory intelligence, innovative designs and methods to deliver fit for purpose outcomes and meet stakeholders needs.
This heterogeneity in scientific study designs, tools and regulations generate turbulent conditions and need for continuous update of knowledge and skills.
With this objective in mind, our session will tackle the actual use of Real World data,  the near future of pragmatic and low-intervention trials; the increasing engagement and influential impact of patients and the needs for transparency and scientific independence throughout the post-authorisation research process (ENCePP/EMA Code of conduct).

Conference Secretariat: C-IN, 5. kvetna 65, 140 21 Prague 4, CZE | tel.: +420 261 174 301 | fax: +420 261 174 307
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