Challenges with the new EuropeanRegulation and Data Transparency

Paris, FranceWednesday, 25th November 2015 - 9:30 am- 5:00 pm

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Challenges with the new European Regulation andData Transparency

On 16 April 2014, the new Regulation EU No 536/2014 of the European Parliament on clinical trials on medi-cinal products for human use was adopted.

The Regulation entered into force on 16 June 2014 and will be fully implemented after 28 May 2016.

The new Regulation, better known as the “Clinical Trials Regulation”, aims to create an environment that is favorable for conducting clinical trials, with the highest standards of patient safety, for all EU Member States. Intrinsic to this is the simpli�cation of current rules, for example:

• a streamlined application procedure via a single entry point;• a single authorisation procedure for all clinical trials;• the extension of the tacit agreement principle to the whole authorisation process.

Not less important the strengthened transparency for clinical trials data.

All information in the EU database submitted in the clinical trials application and during the assessment procedure shall be in principle publically accessible unless the con�dentiality of the information can be justi�ed on the basis of any of the below listed grounds:

• protection of commercially con�dential information;• protection of personal data;• protection of con�dential communication between the Member States in relation to the prepara- tion of the assessment report.

Additionally, the Regulation obliges the sponsor to submit to the Database a summary of results and a lay person summary 1 year after the end of the trial in the EU.

In consideration of the big changes and the new requirements, Sponsors are all focusing in understanding the impacts on their good practice and clinical systems, trying to anticipate any grey areas, critical issues and risks.

Discussion is still open and not all the new processes are clearly de�ned.

Sponsors, Investigators, CROs, Members States and Institutions are all committed in this new challenging arena.

The Scienti�c Board, Erick Gaussens, Chief Scienti�c O�cer at ProductLife Group and Mathias Ganz, Vice Presi-dent R&D IT at Ipsen, will share best practices, results and experiences in this �eld.

O�cial language: French ( slides will be in English )

Who should attend the conference?

The conference is addressed to all the Clinical Research Professionals, belonging to the following departments:

Clinical Research and Development, Quality Assurance, Pharmacovigilance, Clinical Operations, Statistics and Data Management, Information Technology

from Pharmaceutical and Biotechnology companies, Clinical Research Organizations, Academic Centres, Hospital Centres, and Clinical Technology companies.

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Agenda

09:00 - 09:30 Registration and welcome co�ee

09:30 - 09:40 Welcome from the Chair Erick Gaussens , Chief Scienti�c O�cer, ProductLife Group Mathias Ganz, Vice President R&D IT, Ipsen

Speakers con�rmed:

Artem Andrianov - CEO, Cyntegrity Germany Practical methods how to master the new EU Clinical Trials Regulation with risk-based monitoring (RbM)

Eveline Van Keymeulen - Senior Associate, Advocaat, Member of the New York Bar, Allen & Overy LLP Transparency of Clinical Trial Data: The New Regulation and its interaction with the EMA Transparency Policies

Topics that will be covered:

Accelerating Clinical trial through usage of EHR and source data

How EU member states are getting prepared for the new EU Regulation on clinical trials - How the Clinical Trial Regulation �ts with non EC country New EU Regulation on Clinical Trials: challenging issues and associated risks Regulations and their impact on life science companies and the industry - How Data Transparency, IDMP and regulatory inquiries will change the way Life Science companies work

Transparency and vigilance in clinical operation and post marketing

Usage of electronic health records in clinical trial and Clinical data transparency vs the harmonization of clinical data

Final agenda will be available soon

IN ORDER TO ATTEND THE FRENCH ePHARMA DAY, PLEASE COMPLETE THE REGISTRATION FORM FOREACH ATTENDEE AND SEND IT VIA FAX: +39.035.4501262 O VIA EMAIL: epharma@epharmaday.org

Terms of payment

The registration fee must be paid at the time of registration. Con�rmation of event admission will be given on receipt of payment. EasyB reserves the right to refuse late registrations or additional registrations above the maximum accepted number of participants or registrations of roles that are not included in the target of the event.

CancellationPlease note that refunds (70% refund of the registration fee) will only be given if cancellation is received at least one week before the event date. Cancellations will only be valid if made in writing (by email). Transfer of registrations (or name changes) are allowed and should be made in writing within 7 days prior to the event. EasyB reserves the right to postpone or cancel an event, to change the location of an event or to alter the advertised speakers for an event. EasyB is not responsible for any loss or damage as a result of substitution, alteration, postponement or cancellation of an event due to causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade of industrial disputes, terrorism, or hostilities.

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The fee includes: seat at the conference, copy of presenta-tions Speakers who allow he distribution, informative literature for the day, networking lunch, co�ee breaks, organisational o�ce assistance, certi�cate of attendance.

Methods of payment

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€ 490,00 Early Bird fee by 24th October 2015

€ 610,00 ordinary fee (after 24th October 2015)

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For any additional information, please contact: Stefania Sargaepharma@epharmaday.orgPhone: +39.035.515684 - Fax: +39.035.4501262

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