GENERAL INFORMATION. The Venue. The 4 th European Conference on Clinical Research will take place in Vienna, Austria on February 2018.

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2 Table of Contents GENERAL INFORMATION... 2 The Venue... 2 Organisers... 3 CONFERENCE PROGRAMME... 5 PARTNERSHIP OPPORTUNITIES... 8 Target Audience... 8 Partners and Exhibitors Benefits... 8 PARTNERSHIP PACKAGES... 9 GOLD PARTNER... 9 SILVER PARTNER... 9 EXHIBITION PACKAGES NON-MEMBER EUCROF MEMBER VILLAGE BOOTH BRANDED ITEMS FOR DELEGATES Lanyards Conference Bags Conference Bag Insert Pens and Pads Advert in the Printed Programme FURTHER OPTIONS: Public Water Fountains Poster or roll-up banner in the exhibition area Charging Box Satellite Symposium Social Event ORDER FORM

3 GENERAL INFORMATION The 4 th European Conference on Clinical Research will take place in Vienna, Austria on February The Venue Austria Trend Hotel Savoyen Vienna Rennweg Wien, Austria The Hotel Savoyen features a number of event rooms with state-of-the-art technology and elegant design. The large ballroom, measuring a total of 1056 m², is ideal for any kind of event and accommodates up to 1,000 guests. Along with an optimal use of space and flexible room dividing options, the hotel team displays an exceptionally high level of professionalism and service orientation. 2

4 Organisers EUCROF - Executive Board: President: Martine DEHLINGER-KREMER (Germany) Vice-President: Stefano MARINI (Italy) Treasurer: Yoani MATSAKIS (France) Secretary: Simon LEE (UK) Member: Christophe GOLENVAUX (Belgium) EUCROF was founded in Fall The aims and objectives of EUCROF were defined as follows: Promote clinical research of high quality in Europe in general and in the European Union in particular; Form a legal entity to represent the interests of CROs in the EU, for example, in transactions with regulatory bodies, the pharmaceutical-biotechnology industry and the medical research community; Promote a close relationship and mutual understanding between the national member associations and the above-mentioned bodies; Promote the exchange of information between member associations; Develop training and educational programmes for clinical research, and assist the national member associations in setting up such programmes and ensuring their quality; Distribute information on developments in clinical research to health professionals; Organise international conferences and meetings. The Federation consists of members and associate members from over 22 countries: Albania, Algeria, Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Germany, Greece, Israel, Italy, Portugal, Serbia, Slovakia, Spain, Sweden, Switzerland, the Nethrelands, Turkey, UK and Ukraine. It stands for over 352 member CROs and, over 20,000 employees. Since December 2006, the Federation is managed by an Executive Board (see here below) which holds monthly meetings. Each year, the Federation organizes two General Meetings (Spring & Fall) with all its members. 3

5 Organising Committee Chair of the Organising Committee: Darina Hrdlickova, Director, Clinical Management, PPD, Member of the Steering Committee, ACRO-Cz Phone: Darina.Hrdlickova@ppdi.com Chair of the Program Committee Michèle Garot, MD, Managing Director CLINCellence michele.garot@clincellence.com Local Organising Representatives QPS Austria GmbH Representative for EUCROF Robert Wronski, Director Clinical Research Phone: Fax: robert.wronski@qps.com Iveta Nováková Phone: iveta.novakova@qps.com Conference secretariat C-IN Prague Congress Centre 5. kvetna , Prague 4 Czech Republic Phone: info@eucrof-conference.eu Sponsorship and Exhibition Manager: Jana Dvořáková Phone: jana.dvorakova@c-in.eu 4

6 CONFERENCE PROGRAMME Clinical Research in Europe: Are you ready to embrace the changes? Monday 26 February Good Clinical Practice, the new addendum E6 (R2), Part 1: Risk Based Quality Management Chair: Dr. Michèle Garot, Managing Director CLINcellence, Belgium. Time Topic Speaker 14:30-15:00 Risk-Based Monitoring: Where are we in 2018? An Inspector s Experience Gabriele Schwarz, Head of GCP Inspectorate, Federal Institute for Drugs and Medical Devices, BfArM, Germany. 15:00-15:30 The Good, the Bad and the Site in Risk Based Monitoring, the sites perspective over the years. Dr. Vivienne van de Walle, MD, Ph.D., CPI Director PT&R, The Netherlands. Member of the Leadership Council the Society of Clinical Research sites (SCRS). 15:30-16:00 Defining Risk factors and tolerance limits, hints and tips. Mag. Claudia KRIEBAUM Manager, Risk Based Monitoring Eli Lilly Regional GmbH; Austria. 16:00-16:30 Computerized Clinical Trials? A modern way to gain quality in study design and optimise drug development. Francois-Henri Boissel, MSc, CEO Novadiscovery, France. 16:30-17:00 Coffee Break Part 2: Operating Models further re-enforced by new regulations & guidelines Chair: Yoanni Th. Matsakis, President Telemedicine Technologies S.A.S., France. 17: 00-17:30 Inspection findings from etmf implementations. Andy Fisher, Senior GCP Inspector, GCP Inspectorate, MHRA, UK. 17:30-18:00 General Data Protection Regulation (GDPR) & big data in the healthcare sector: How to draw value for patients and companies out of the new EU framework and its challenges? Cécilia Alvarez, European Data Protection Officer Lead, Pfizer, Spain. Cécile Théard-Jallu, Partner Attorney, De Gaulle Fleurance & Associés, France. 18:00-18:30 esra - esource Site Readiness Assessment tool: Is your EHR system suitable for originating records that will be used in regulated clinical trials? Dr. Yvonne Rollinger, Managing Director, Omnicomm Europe, Germany. Representative of the eclinical Forum esra Initiative. 19:15-20:00 Cocktail 20:00 Social Event 5

7 Clinical Research in Europe: Are you ready to embrace the changes? Tuesday 27 February 1 st Parallel Sessions: GCP compliance of e-systems and Technical Solutions Chair: Alan Yeomans Quality Manager, PCG Solutions, Sweden, Co-chair of the eclinical Forum Regulatory Expert Group, Co-chair of the EUCROF Working Group New Technologies. Clinical Trials in the Paediatric Population Chair: Dr. Martine Dehlinger-Kremer, President EUCROF Vice-President, Global Medical and Regulatory Affairs, SynteractHCR, Germany, Chair of the EUCROF Working Group Paediatric. Co-chair: Georg Mathis, CEO Appletree CI Group AG, Switzerland. Time Topic Speaker Topic Speaker 08:30-09:00 What makes a good audit trail dataset? Andy Fisher, Senior GCP Inspector, GCP inspectorate, MHRA, UK. The Paediatric Regulation revision/update. Dr. Marek Migdal, Deputy Head of Children s Memorial Health Institute, Poland. Member EMA Paediatric Committee (PDCO) 09:00-09:30 Contractual requirements on the responsibilities of e-systems Vendors with regards to GCP. Wolfgang Summa, Merck Group, Germany. Pan European Paediatric Network. Dr. Mark Turner, Institute of Translational Medicine, University of Liverpool, UK. Chair European Network of Paediatric Research at EMA, UK. 09:30-10:00 Risk based validation and Agile development. Jesper Rosendal, Senior Manager Corporate Quality Assurance IT, Lundbeck, Denmark. Certification of clinical trial center in paediatric perspective. Prof. Paolo Rossi, Director Institute of Child Health, Bambino Gesu Children s Hospital, Italy. Member EMA Paediatric Committee (PDCO) 10:00-10:30 Panel Discussion. All Patient involvement in paediatric clinical research. Claas Röhl, Founder NF Children, Chair Austrian EUPATI platform; EUPATI fellow, Austria 10:30-11:00 Coffee Break 6

8 Clinical Research in Europe: Are you ready to embrace the changes? Tuesday 27 February 2 nd Parallel Sessions: European Medical Device Regulations Chair: Dr. Antoinette van Dijk, Scientific Director AICRO, Italian association of CROs Co-chair of the EUCROF Working Group Medical Devices. New European Data Privacy Regulation Chair: Isabelle Abousahl, President Alcoam by design SAS, France, Member of the EUCROF Working Group New Technologies. Co-chair: Thierry Lepoutre, Managing Director, Lambda Plus, Belgium. Time Topic Speaker Topic Speaker 11:00-11:30 Highlights and Challenges of the EU Medical Device Regulations. Gert Bos, Executive Director & Partner Qserve Group, Netherlands Data Protection and Clinical Trial Agreements, seen through the eyes of a trial site. Markus Kastelitz, Data Protection Officer,(formerly) Medical University of Vienna, Austria 11:30-12:00 MDR Impact Assessment for Manufacturers. Luca Orlandini MD, Vice President Global Medical Affairs, Smith & Nephew, Switzerland How to comply with the GDPR in a global and innovative environment? Sarah Taïeb, Global Data Privacy Manager, IPSEN, France 12:00-12:30 Clinical Evaluation according to MEDDEV 2.7/1 revision 4 and Medical Device Regulation. Carolina Gualtieri, Member Medical Device Group SSFA, Fondazione Policlinico Gemelli, Italy PhUSE Data deidentification standard for CDISC Data Models Jean-Marc Ferran, Consultant & Owner, Qualiance; Data Transparency Working Group Lead, PhUSE; Denmark 12:30-13:30 Lunch Break 7

9 PARTNERSHIP OPPORTUNITIES We invite you to take your brand, product or message to the next level by joining an elite group of professionals who have one goal in mind: to help you reach your full potential. Around 500 individuals in the same place, each one leaving with a career-changing experience. Reach Individuals, Not Targets! Ignite your brand visibility, create meaningful international connections & network your way to success. Get the opportunity to meet with individuals from the following sectors: Pharma, Biopharma, Biotechnology, Medical Device Organizations CROs, Site Management Organizations Clinical Trial Investigators, Site Personnel, Academic Researchers Regulators Patients and others Partners and Exhibitors Benefits The Exhibition is the central place of interaction at the EUCROF Conference. All coffee and refreshment breaks, lunches, welcome reception and other EUCROF activities are held in the exhibition hall, giving exhibitors ample opportunities to connect with the attendees. Your participation as a partner or exhibitor will automatically include the following benefits: Listed as a partner or as an exhibitor including your company s logo and web link on the official website of the conference. Listed as a partner or as an exhibitor including your company s logo and company profile in printed materials. Visibility on roll up banners dedicated to partners. Expression of thanks at the Opening and Closing Ceremonies. Logos on slides during breaks in the lecture rooms. 8

10 PARTNERSHIP PACKAGES GOLD PARTNER EUR The Gold Partner will be offered the following benefits: Satellite Symposium (1 hour timeslot) 12 sqm Exhibition space (additional space will be charged at a special rate of 200 EUR per sqm) and priority of booth location choice 5 complimentary Conference registrations 3 complimentary tickets to Conference dinner 3 complimentary exhibitors passes Full page advertisement in programme book Premium placement of the Partner s logo and URL on the official website, Insert into delegate bags Mailing to the delegates before or after the conference Description (max. of 200 words) in the programme book Permission to use the partnership of the Conference for own advertising SILVER PARTNER EUR The Silver Partner will be offered the following benefits: 9 sqm Exhibition space (additional space will be charged at a special rate of 200 EUR per sqm) and priority of booth location choice after Gold Partner) 3 complimentary Conference registrations 1 complimentary ticket to Conference dinner 2 complimentary exhibitors passes Half page advertisement in programme book Premium placement of the Partner s logo and URL on the official website Insert into delegate bags Description (max. of 100 words) in the programme book Permission to use the partnership of the Conference for own advertising 9

11 EXHIBITION PACKAGES NON-MEMBER The Non-member Exhibition Package including following: EUR / 6 sqm 6 sqm (2x3m) exhibition space Special price for additional exhibition space: 400 EUR/ sqm and 200 EUR/sqm per shell scheme package 2 complimentary exhibitors passes Special price for additional exhibitor registration: 200 EUR Visible as exhibitor on the conference webpage (logo and web link) Visible as exhibitor in the programme book (logo and company profile) 6 sqm of booth equipment package that includes: White panels/silver alloy construction Electricity supply 220V / 3,5 kw Fascia board company name Daily cleaning Carpet 1 round table and 4 chairs Spotlights (1 spotlight per 3 sqm) EUCROF MEMBER EUCROF member Exhibition Package including following: EUR / 6 sqm 6 sqm (2x3m) exhibition space Special price for additional exhibition space: 200 EUR/ sqm and 200 EUR/sqm per shell scheme package 1 complimentary conference registration 2 complimentary exhibitors passes Special price for additional exhibitor registration: 180 EUR Visible as exhibitor on the conference webpage (logo and web link) Visible as exhibitor in the programme book (logo and company profile) 6 sqm of booth equipment package (as described above) 10

12 VILLAGE BOOTH EUR / 9 sqm EUR / 12 sqm The Village booth offers more visibility with a larger space. Associations can share the exhibition area and promote their members Type Size in sqm Free exhibitors Promotion of: Price in EUR excl. VAT passes A 9 (3x3m) 4 2 to 5 entities B 12 (3x4m) 6 6 to 9 entities The same services as the exhibition package for EUCROF members described above applies. All entities (the Association and its members) will be visible individualy on the website, and on printed material. EXHIBITOR REGISTRATION INCLUDES Access to the exhibition hall Welcome reception Coffee breaks Lunches A good flow of delegates is guaranteed thanks to catering stations (for coffee breaks and lunches) being spread throughout the exhibition floor. Booth allocation is organised on a firstcome, first-served basis. 11

13 BRANDED ITEMS FOR DELEGATES Lanyards (Exclusive) Each delegate will be given a lanyard with a name badge, which will indicate their name and the country they come from and act as an identification pass. The partner s logo will be printed on the lanyard, together with the conference logo. The partner will also be mentioned in the final programme and on the conference website. Lanyards provided by the partner Lanyards produced by the organiser EUR EUR Conference Bags One bag including Conference materials will be distributed to all full registered delegates as they arrive on site at the Conference. As a partner of the Conference bags, you will have your company logo printed in a prominent position on the bag along with the Conference logo. (Type, size and color of the bags as well as position and size of the logo will be at the organizer discretion). Sponsored conference bag (exclusivity, produced by the partner with both logos) EUR Conference bag produced by the organiser (with both logos) EUR Conference Bag Insert An insert in the conference bag could be A4 or A5 size double-sided, color or black and white flyer/promotional piece. This flyer could be text only promoting activities on your exhibition stand or it may be an existing corporate flyer of information on your services or products. Rate per insert 900 EUR Pens and Pads This is an exclusive opportunity. The logo of your company will be, along with the conference logo on notepads and pens. Delegates particularly appreciate receiving writing pads and pens as they are very useful for the scientific sessions. Pens and pads provided by the partner. Rate for writing pads insertion (exclusivity) Rate for pens insertion (exclusivity) EUR EUR Advert in the Printed Programme The final programme will be provided to all registered delegates including speakers, official guests, and exhibitors. Advertisement on the inner full page Advertisement on the inner half page EUR 900 EUR 12

14 FURTHER OPTIONS: Public Water Fountains Water fountains for the delegates will be placed in all public areas for the whole conference period. In case you decide to sponsor this item, your company logo will be placed on every crucible and on the water tanks as well. The partner will be mentioned in the printed material. Rate EUR Poster or roll-up banner in the exhibition area The partner has an opportunity to place a company s poster (Maximum A0 size: 84.1cm x 118.9cm) or roll-up banner in the exhibition area. The stand for the poster will be arranged by the organizer. The production of posters or banners for the partners is possible upon agreement with the organizer with extra charge. Rate for displaying your poster or roll-up banner 500 EUR Rate for the production of a bigger banner (200X240cm) 900 EUR Charging Box Attendees are using their smart phones and tablets that need to be regularly charged. Charging stations are increasingly becoming a standard and popular feature of modern day events. By sponsoring this item, you can brand the box the way you want and connect with a wide audience. Rate per charging box including full branding EUR 13

15 Satellite Symposium (offered on quotation) The organisers will be happy to assist with the booking of the space, installation of AV equipment, and refreshments for any meetings you may need inside or outside the venue. Communication about allocated meeting space can be communicated through the official website of the conference. Quotations are done on a case-by-case basis according to your needs. Social Event (offered on quotation) All partners of a social event will be mentioned in the conference website and printed programme book. All social events are offered on an exclusive basis. Hang your company banner, distribute the napkins or menus with your company s logo and be visible during informal moments of the conference such as coffee breaks, welcome reception or conference dinner. Quotations are done on a case-by-case basis according to your needs. Contact: Jana Dvorakova, Sponsorship Manager Mob: jana.dvorakova@c-in.eu 14

16 ORDER FORM COMPANY NAME: CONTACT NAME: COMPANY ACTIVITY: POSTAL ADDRESS: ZIP CODE AND CITY COUNTRY: TELEPHONE: FAX: Your VAT Number: LIST OF PACKAGES SELECT ITEM Main Partner Partner Non-Member Exhibition Package EUCROF Member Exhibition Package Village booth (9 sqm/ 12 sqm) PRICE IN EURO (excl. OTHER ITEMS Please fill in PRICE IN EURO (excl. All prices are VAT excluded. DATE:...SIGNATURE AND COMPANY STAMP: Please fill in the order form and send it to The advance invoice will be sent to you upon receiving the filled order form Please send your company logo in curves format and your weblink along with the order form. 15