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German ePharma Day

The Westin Grand Munich, Munich, Germany

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Check ePHARMA DAY happening in Milan, Italy on 20 May 2020

The German ePharma Day, organized by the EasyB will take place on 11th June 2015 at the The Westin Grand Munich in Munich, Germany. The conference will cover areas like Welcome from the Scientific Board, Practical methods how to master the new EU Clinical Trials Regulation with risk-based monitoring (RbM), Public Data Sharing in real life: Boehringer Ingelheim’s experience as a member of ClinicalStudyDataRequest.com.


09:00 AM - 05:10 PM General Hours

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Paid Ticket Starts from 360 EUR View Details


100 - 500
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Science & Research


11 Jun 2015

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ePHARMA DAY at other locations
Milan, Italy 20 May 2020
Copenhagen, Denmark 27 May 2020
Brussels, Belgium 07 Nov 2019
Paris, France 20 Nov 2018
Hoofddorp, Netherlands 11 Oct 2018
London, UK 17 Oct 2016
Berlin, Germany 13 Apr 2016
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EasyB Italy

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Artem Andrianov

Artem Andrianov

CEO & Founder at Cyntegrity Germany GmbH Germany
Dr. Martine Dehlinger-Kremer

Dr. Martine Dehlinger-Kremer

Global Vice President Medical and Regulatory Affairs at SynteractHCR United States
Amit Bahulayan

Amit Bahulayan

Heike Meininger-Schön

Heike Meininger-Schön

Heilpraktikerin Psychotherapie, Kinesiologin Germany
Hans-Juergen Woerle

Hans-Juergen Woerle

Vice President Therapeutic Area Metabolism, Corporate Devision Medicine at Boehringer... Germany

Schedule & Agenda

Thu, 11 Jun 09:00 AM - 09:30 AM
Thu, 11 Jun 09:30 AM - 09:40 AM
Welcome from the Scientific Board
About the speakerDr. Herbert Esku00f6tterHerbert Esku00f6tter MD, PhD, MSc studied chemistry and medicine at the University of Cologne, Germany until 1989. He made two theses in biophysical chemistry and experimental surgery. After additional training at the Battelle Institute e.V. in Frankfurt he received his license as a physician. Additionally he has a diploma in sports medicine. He started his career in the pharmaceutical industry with Sandoz AG (Nuremberg) in 1991. After this he held various positions in clinical research and medical affairs within the pharmaceutical industry (e.g. Boehringer Ingelheim GmbH & Co KG as Head of Hospital group) and CROs (e.g. Omnicare Clinical Research GmbH & Co KG as Senior Medical Director). He has more than 20 years experience in clinical research and performed national and international studies (Phase I-IV) across various therapeutic areas including paediatric trials.Heike Schu00f6nHeike Schu00f6n, based in Germany, is co-founder and Managing Director of LUMIS International GmbH.She has worked in leading positions in clinical research for more than 20 years. Her experience ranges from conducting national and international Phase I clinical trials all the way to registration and post marketing activities and business development on behalf of contract research organizations (CROs) and the biotechnology industry. Her previous positions included operational management and general management. She holds a masteru2019s degree in psychology and a masteru2019s degree in business administration.Since 2002, she has been active in the Association of Clinical Research Professionals (ACRP) where she also served as a member of the Board of Trustees and as its Chair in 2010. She is regular lecturer and committee member of the Drug Information Association (DIA).
Thu, 11 Jun 09:40 AM - 10:20 AM
EMA policy on publication of clinical data for medicinal products for human use (2014): Outline and relation to the new Clinical Trials Regulation
EMAu2019s decision to proactive disclosure of clinical trial data was first outlined in the article u2018Open clinical trial data for all? A view from regulatorsu2019 (PLoS Medicine, April 2012). The developmental steps leading to adoption of the policy included a public consultation process. In 2013, the Agency received about 1,138 comments from many stakeholders; besides others also from the European Federation of Pharmaceutical Industries and Associations (EFPIA). The EMA policy on publication of clinical data for medicinal products for human use was released on 2nd October 2014 (policy/0070) with the effective date on 1st January 2015.The policy determines how EMA will publish information on clinical trials that are part of marketing authorization applications (MAAs) for medicines that have been authorized via the agency.The presentation will provide a summary of the purpose, main objectives and scope of this new policy. The main characteristics of the policy (such as introduction of a publication process for clinical reports, management of commercial confidential information [CCI] in clinical reports and redaction principles, methods for balancing the protection of patientsu2019 privacy whilst retaining scientific value of the data, the stepwise implementation of the policy) will be introduced and commented in detail.Finally, it will be addressed that this policy is beyond the scope of the new transparency requirements based on the European Clinical Trial Regulation EU No. 536/2014 (known as the new Clinical Trial Regulation), as it applies for example also to clinical trials conducted outside the EU but submitted to EMA for marketing authorization in Europe. The EMA policy on publication of clinical data will serve as a useful complementary tool ahead of the implementation of the new Clinical Trials Regulation when it comes into force no sooner than May 2016, and is without prejudice to the provisions of the Clinical Trials Regulation.
Thu, 11 Jun 10:20 AM - 11:00 AM
Public Data Sharing in real life: Boehringer Ingelheimu2019s experience as a member of ClinicalStudyDataRequest.com
This presentation starts with a description of BIu2019s experience to develop and implement its comprehensive transparency policy. We focus both on theoretical aspects like compliance with data protection laws and patientu2019s informed consent, but also on the practical challenges such as anonymization of individual subject data sets from clinical trials. Then we describe the framework of ClinicalStudyDataRequest.com (CSDR) and provide BIu2019s experience from the practical handling of more than 30 incoming research proposals since beginning of CSDR in 2014. Finally, we put our CSDR experience into perspective and reflect on the potential public benefit of the different aspects of clinical trial transparency.About the speakerHans-Juergen LompHans-Juergen Lomp, Dipl.Math.More than 20 years of pharma industry experience as a statistician. Worked for 10 years for Hoechst, now Sanofi, as a project statistician in Diabetes and Cardiovascular, as well as a statistics manager. Changed to Boehringer Ingelheim (BI) to become Group Head Statistics, covering all statistical aspects from basic research, non-clinical development, pharma production development, as well as clinical development and medical affairs support. Chaired the statistics leader group of the VFA (Association of Germanyu2019s researched based pharma companies) for several years. In 2013 has been appointed Global Head of Statistics for BI. Co-chairs the BI Transparency Initiative and is also responsible for clinical trial results disclosure at BI as well as for public access procedures to BI data.
Thu, 11 Jun 11:00 AM - 11:30 AM
Coffee break
Thu, 11 Jun 11:30 AM - 12:10 PM
Protection of personal data
The presentation will focus on the protection of personal data in the framework of clinical trials with humans. In this context data protection aspects concern mainly study participants but also the investigator and his/her study team, the sponsor and the monitoring team and finally the competent authorities in the member states are affected. The speaker will summarize the status quo of data protection and discuss various legal aspects concerning the collection, use and transfer of coded and anonymized data to different stakeholders. She will consider in addition the development and impact of modern data collection and monitoring tools (e.g. remote monitoring, use of health apps, software, etc.) on the data protection. The interface between regulatory requirements and data protection regulations has to be defined and considered when planning clinical trials. Finally the question has to be discussed which consequences the new Clinical Trial Regulation and the forthcoming European data transparency activities for the disclosure of clinical trial data might have for the effective protection of personal data in particular with regard to sensible health data.About the speakerDr. Heike WachenhausenDr Heike Wachenhausen studied law at the University of Gu00f6ttingen. Her dissertation on u2018Medical experiments and clinical trials on people unable to give their consentu2019 won the Science Award bestowed by Gesellschaft fu00fcr Recht und Politik im Gesundheitswesen (GRPG e. V.) in 1999. At the same time, she gathered valuable experience in the research and development of pharmaceuticals and medical devices providing legal support to two ethics committees (Gu00f6ttingen and Hannover).From 2000 to 2003 she worked as a lawyer in the industry working group u2018Healthcare, life sciences & chemicalsu2019 at the international law firm Clifford Chance in Du00fcsseldorf. She then moved to the law firm, Stru00e4ter Rechtsanwu00e4lte in Bonn, where she worked from 2003 to 2009. At both firms she specialized in advis
Thu, 11 Jun 12:10 PM - 12:50 PM
A new Clinical Trial Regulation in the EU u2013 chances and risks
The new EU Clinical Trial Regulation (Regulation (EU) No 536/2014) was adopted on the 16th April 2014 and published in the Official Journal of the European Community on the 27th May 2014. This new EU Clinical Trial Regulation (EU-CTR) shall enter into force at the earliest on 28 May 2016, but the final decision is linked to the official declaration by the EMA/EU-Commission that a new European-submission portal is fully functional at least six months in advance. So delays may occur. The EU-CTR will fully replace the current EC directive 2001/20, which has governed clinical trials in the European Union since 2004.Main focus of the EU-CTR is a European authorization procedure for clinical trials to be conducted in the EU. In this regard the new European-submission portal, national processes/systems and new transparency measures have to be set up, adjusted or newly implemented. The presentation will address the basics behind the new European authorization procedure for clinical trials and discuss the potential opportunities and challenges that may arise from this new EU-CTR for EU-member states, academic institutions, Pharma companies and other stakeholders.About the speakerDr. Thorsten RuppertDr. Thorsten Ruppert is senior manager for research, development and innovation in the Association of Research-Based Pharmaceutical Companies - vfa. In 1999 he received a doctorate in biochemistry at the Free University in Berlin. Also in 1999 he joined NOXXON Pharma AG as a scientist in the Department of Research & Development. From there he moved internally in the clinical research department and in 2002 he became Director of Scientific Marketing, Division of Business Development. In 2004 he joined the vfa, where - among other areas u2013 he is responsible for clinical trials, research issues, animal research and biobanking.
Thu, 11 Jun 12:50 PM - 01:50 PM
Networking Lunch
Thu, 11 Jun 01:50 PM - 02:30 PM
Approval of the study by the Competent Authority (CA)
About the speakerDr. Jens PetersThe biography will be available soon
Thu, 11 Jun 02:30 PM - 03:10 PM
The role of the Ethics Committee for approval
According to the new clinical trial regulation 536/2014 (CTR) authorisation for a clinical trial will be divided in two parts. In multinational trials a single European decision will be obtained for Part I which covers the aspects i) of whether a clinical trial is a low-intervention clinical trial, ii) the anticipated therapeutic and public health benefits, the risks and inconveniences for the subject, (based on the pharmacology and toxicology of the investigational medicinal product (IMP) and previous clinical studies as documented in the Investigatoru2019s brochure (IB) and on the research protocol) iii) quality of the IMP and iv) completeness and adequateness of the IB. National aspects are evaluated in Part II which covers informed consent, arrangements for rewarding or compensating subjects and investigators, data protection, suitability of clinical trial sites and of individuals conducting the clinical trial, damage compensation and rules for the collection, storage and use of biological samples. According to the CTR, the review by ethics committees (ECs) shall be performed in accordance with national law and may encompass aspects of Part I and Part II. The aspects i) and ii) of Part I and all aspects of Part II should, however, be evaluated by ECs, in order to meet the requirements of the Declaration of Helsinki. Rules and timelines for the interaction between EC and competent authority must be developed to ensure a timely single national decision of the concerned Member State .The final authorization of a clinical trial by a concerned Member State will have to be refused, if the national EC issued a negative opinion.About the speakerProf. Dr. Kurt Racku00e9Kurt Racku00e9, born in 1952, studied medicine (University of Mainz 1972-78), was research fellow and associate professor at the Department of Pharmacology University of Mainz and became Professor of Pharmacology and Toxicology (University Frankfurt 1992-1995, University Bonn since 1995). His current major researc
Thu, 11 Jun 03:10 PM - 03:40 PM
Coffee break
Thu, 11 Jun 03:40 PM - 04:20 PM
News and challenges from the regulatory point of view
The original intent of the Clinical Trials Directive 2001/20/EC was to simplify and harmonize the administrative provisions governing clinical trials in the European Union. However, experience has proven that a coordinated approach to the regulation of clinical trials has been only partly achieved, making it difficult to perform a clinical trial in several Member States. As a consequence the European Commission determined to develop a legal Regulation that would repeal the earlier Directive and harmonize the procedures for conducting clinical trials. The Regulation of the European Parliament and of The Council on Clinical Trials on Medicinal Products for Human Use, repealing Directive 2001/20/EC was published in the Official Journal on 27th May 2014 and is expected to become effective in June 2016 if the given preconditions are met.The scope of the new Regulation is extensive, with several primary components covered in the core text and multiple appendices, including: Authorization procedures; Start of trial, suspension or temporary holds, early termination; Protection of subjects, informed consent; Conduct of trials; Safety reporting; IMP manufacturing, labelling and import; Insurance.Certain aspects are not covered by the Regulation and remain country specific, including: Ethics; Legal representative of the subject not able to provide IC, Substantial rules of liability in the case of damages; Requirements for investigators and site qualification; Requirements for country/site specific documents such as originals and copies, notarization, language. Additional approvals might still be required in some countries.That said, there are several advantages and simplifications brought by the new Regulation and at the same time some challenges.The presentation will provide an overview of the Regulation from the Regulatory point of view as well as some of the challenges the Regulation might bring.About the speakerDr. Martine Dehlinger-KremerDr Martine Dehlinger-Kr
Thu, 11 Jun 04:20 PM - 05:00 PM
Practical methods how to master the new EU Clinical Trials Regulation with risk-based monitoring (RbM)
The new EU Clinical Trials Regulation (CTR) becomes applicable not earlier than on 28th of May 2016. It introduces a number of changes in the clinical trialu2019s application, operations, documentation, and assessment. Although CTR is not taking the direct reference on RbM, it refers to principles of Good Clinical Practice (GCP) and Quality by Design (QbD). These principles are the underlying in RbM as well. Therefore, the author offers to apply RbM as a practical mechanism and process in order to embrace the new EU regulation.The regulation underlines the interest of subjects and assigns to them an ultimate priority over all other interests.What tools are available in order to help us in the implementation of the new regulations? The RbM approach offers large flexibility and control for these purposes.The identification of risks, which appear if the regulation is not correctly implemented, helps to avoid them. How to achieve that? Apply several key risk indicators (KRIs) within the digital infrastructure, which can help to monitor automatically the clinical trial and free your time for the real research.RbM can be defined rather u201cnarrowu201d following the FDAu2019s definition:Remote monitoring (application of technologies to access the data remotely, saving the costs of on-site visits.)Reduced monitoring (targeted Source Data Verification) orTriggered monitoring (monitoring based upon pre-defined triggers, i.e., when risk was already identified)or u201cbroaderu201d, following the EMAu2019s definition:RbM is u201cpreventive clinical trial management approach, which aims to identify, assess, control, communicate and review the risks associated with the clinical trial during its lifecycle in order to guarantee the protection of trial subjectsu2019 rights, well-being, integrity and safety and the assurance of quality of data and the trial credibility.u201d1In the EMA reflection paper the RbM is more as a risk management, which goes beyond the CRAu2019s responsibilities. The author is an advo
Thu, 11 Jun 05:00 PM - 05:10 PM

Visitor Ticket Price

490 EUREarly Bird fee By 11th May 2015
610 EURordinary fee After 11th May 2015
440 EURPatronage members fee
360 EURAcademy, Public Administration, Freelanc
48.151998 11.617150

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