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Challenges with the new European
Regulation and Data Transparency
Thursday, 11th June 2015
The Westin Grand Munich - MUNICH (Germany) - Arabellastraße 6
09:30 - 17:30
EVENT SPONSORED BY:
MEDIA PARTNER:
Event organised by:
WWW.EPHARMADAY.ORG
Challenges with the new European Regulation and
Data Transparency
Thursday, 11th June 2015 - The Westin Grand Munich - Munich (Germany), Arabellastraße 6 - 09:30 - 17:30
On 16 April 2014, the new Regulation EU No 536/2014 of the European Parliament on clinical trials on medicinal 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 simplification 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 confidentiality of the information can be justified on the basis of
any of the below listed grounds:
•
protection of commercially confidential information;
•
protection of personal data;
•
protection of confidential communication between the Member States in relation to the preparation 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 defined.
Sponsors, Investigators, CROs, Members States and Institutions are all committed in this new challenging arena.
The Scientific Board, Heike Schön, Managing Director at LUMIS International and Dr. Herbert Eskötter, Medical
Consultant, will share best practices, results and experiences in this field.
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.
Official language: German (slides will be in English. Legal texts - if applicable - in German language)
WWW.EPHARMADAY.ORG
Challenges with the new European Regulation and
Data Transparency
AGENDA
EVENT SPONSORED BY:
09:00 - 09:30
Registration and welcome coffee
09:30 - 09:40
Welcome from Scientific Board
Heike Schön, Managing Director, LUMIS International
Dr. Herbert Eskötter, Medical Consultant
09:40 - 10:20
Dr. Martine Dehlinger-Kremer - Global Vice President Medical and Regulatory
Affairs, SynteractHCR Germany
News and Challenges from the regulatory point of view
10:20 - 11:00
Dr. Thorsten Ruppert - Senior Manager, Research/Development/Innovation, VFA
(Research-Based Pharmaceutical Companies)
A new Clinical Trial Regulation in the EU – chances and risks
11:00 - 11:30
Coffee break
11:30 - 12:10
Dr. Jens Peters - Head of Clinical Research, BPI. e.V.
Approval of the study by the Competent Authority (CA)
12:10 - 12:50
Prof. Dr. Kurt Racké - Institute of Pharmacology, University of Bonn
The role of the Ethics Committee for approval
12:50 - 13:50
Networking Lunch
13:50 - 14:30
Dr. Claudia Werner - Medical Advisor, A. Menarini Research & Business Service
GmbH
EMA policy on publication of clinical data for medicinal products for human
use (2014): Outline and relation to the new Clinical Trials Regulation
MEDIA PARTNER:
14:30 - 15:10
Dr. Hans-Juergen Lomp - Medical Data Services / Biostatistics, Boehringer
Ingelheim
Pharma GmbH & Co KG
Public Data Sharing in real life: Boehringer Ingelheim’s experience as a
member of ClinicalStudyDataRequest.com
15:10 - 15:40
Coffee break
15:40 - 16:20
Dr. Heike Wachenhausen - Attorney at Law, Wachenhausen Rechtsanwälte
Protection of personal data
16:20 - 17:00
Dr. Artem Andrianov - CEO, Cyntegrity Germany GmbH
Practical methods how to master the new EU Clinical Trials Regulation
with risk-based monitoring (RbM)
17:00 - 17:10
Conclusions
WWW.EPHARMADAY.ORG
EVENT SPONSORED BY:
Registration
In order to attend the German ePharma Day conference, you can send the filled registration form,
for each attendee, via email: [email protected] or via fax: +39.035.4501262 and pay by
bank transfer
OR
you can directly register online and pay by credit card, clicking on:
http://events.lsacademy.it/conferences
Registration fee
€ 490,00 Early Bird extended until 29th May 2015
€ 610,00 ordinary fee (after 29th May 2015)
€ 440,00 Patronage members fee
€ 360,00 for Universities, Hospitals, public administration and Freelancer
The fee includes: seat at the conference, copy of presentations of Speakers who allow the distribution, informative literature for the day, networking lunch, coffee breaks, organisational office
assistance, certificate of attendance.
Methods of payment
MEDIA PARTNER:
If you pay by bank transfer, please attach proof of payment to the registration form.
Bank transfer payable to:
EasyB S.r.l.
Via Roma, 20 - 24022 Alzano Lombardo (BERGAMO)
VAT number: IT03633040161
Banca Popolare di Vicenza - Filiale di Nese
IBAN: IT36 B057 2853 2508 2657 0697 999
SWIFT Code: BPVIIT21826
If you pay online (by credit card), you need to register clicking on:
http://events.lsacademy.it/conferences
Invoice will be sent following receipt of payment as proof of received payment
How to reach The Westin Grand Munich - Munich
For further information please visit:
www.epharmaday.org or
www.westingrandmunich.com
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 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.
Cancellation
Please 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.
Information collection and use
Participants information is collected and utilised by EasyB S.r.l. and sponsor companies in accordance with Italian Legislative Decree 196/2003. Data collected will be used and communicated to third parties for
the purposes of event organisation and may be used to communicate future similar initiatives. Participants may at any time verify the accuracy of the information and request changes or deletion.
WWW.EPHARMADAY.ORG
IN ORDER TO ATTEND THE EVENT, PLEASE COMPLETE THE REGISTRATION FORM FOR EACH
ATTENDEE AND SEND IT VIA FAX: (+39) 035.4501262 OR VIA EMAIL: [email protected]
€
€
€
€
490,00
610,00
440,00
360,00
Methods of payment
Early Bird fee extended until 29th May 2015
Ordinary fee (after 29th May 2015)
Patronage members fee
for Academy, Public Administration, Freelance
(please specify................................)
The full amount must be paid on registration to
EasyB s.r.l by bank transfer.
If paying by bank transfer please attach proof of
payment to the registration form. Bank transfer
payable to:
The fee includes: seat at the conference, copy of presentations Speakers who allow
the distribution, informative literature for the day, networking lunch, coffee breaks,
organisational office assistance, certificate of attendance.
For any additional information, please contact:
[email protected] Tel.: +39.035.515684
Name
Company
EasyB S.r.l.
Via Roma, 20 - 24022 Alzano Lombardo (BG)
VAT: IT03633040161
Banca Popolare di Vicenza - Filiale di Nese
IBAN: IT36 B057 2853 2508 2657 0697 999
SWIFT Code: BPVIIT21826
Fax: +39.035.4501262
Surname
Job Title
Address
City
Phone number
Post Code
Fax
E-mail
Special dietary requests
INVOICING DETAILS
Company name
Address
Mail address
(if different)
City
Post Code
VAT number
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 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.
Cancellation
Please 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.
Information collection and use
Participants information is collected and utilised by EasyB S.r.l. and sponsor companies in accordance with Italian Legislative Decree 196/2003. Data collected will be used and communicated to third
parties for the purposes of event organisation and may be used to communicate future similar initiatives. Participants may at any time verify the accuracy of the information and request changes or
deletion.
Date ……………..….......
Signature…...........………………