2014 berlin_ operational excellence in clinical trails

www.kp-morgan.com / [email protected]

OECT Summit 12th – 13th March 2014, Berlin, Germany

Two Days Conference

Speakers Include:

Jo Burmester, Director Global Operations, PharmaSchool Ltd.

Klaus Beinhauer, Regional Head Global Monitoring and Site Management EU

Kai Langel, Founder and Director, eClinical Health

Pieter Proot, Senior Global Trial Leader, Novartis.

Pete Chan, Chief Innovation Advocate,Tudor Reilly Health

Urban Olsson, Clinical Development Manager,AstraZeneca

Philippe Auby, Divisional Director Paediatrics and CDC, Lundbeck

Dr Ulrike M. Grimm Vice President, Global Clinical Operations, Vifor Pharma

Wolfgang Summa, Vice President of outcomes delivery and support, ERT

Michaela Kroeger, Performance & Metrics Lead, Global Clinical Operations, Merck Serono.

Aleksandra Jankielewicz, Clinical Director, Head Europe North/Central/East Site Management & Monitoring, Abbvie

Sanja Bordessoule, International Clinical Trial Manager, Sanofi

Iva Dumbovic Dubravcic, Clinical Trial Manager, Roche

Rosamund Round, Associate Director Patient Recruitment, Parexel International

Lydia Dorrego, Former Clinical Operations Director, Spain

Yamin Khan, Executive Vice President Clinical Development, Pharm-Olam

Jolanta Bilinska, Head of Department of International Cooperation National health Fund Lodz, International Alliance of Patients Organizations chair elect and President Patient Safety Foundation Poland.

Chairman: Jo Burmester, Director Global Operations, PharmaSchool Ltd & Editor The Journal of Clinical Research & GCP

Operational Excellence in Clinical Trials Summit Study Feasibility, Patient Recruitment Retention and Social Media in Patient Recruitment

12th – 13th March 2014, Berlin, Germany

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Two Days Conferencewww.kp-morgan.com / [email protected]

Operational Excellence in Clinical Trials Summit12th – 13th March 2014, Berlin, Germany

Topics at a Glance: You should not miss this annual opportunity if you are – Chiefs, Directors, Heads, Senior Manager, Leaders and Executives from

Clinical Operations, Clinical Developments/Research, Clinical Trials, Clinical Program, CPM, Study and Feasibility Management, Global Monitoring Operations, International Clinical Research, Patient Recruitment & Retention, Medical Operations, Medical Affairs, Medical Advisors, MSL, Data Management, Compliance and Regulatory

A basic fact about clinical trial research: “Even though a study may be very well designed and funded,it cannot bring a drug to market without the availability of suitable subject.“

Got a question?

Contact Mr. Andreas Raab [email protected]

Tel: +35 31 437 85 75Web: www.kp-morgan.com

Study Feasibility

• Risk assessment

• Operational risk and competitive risk within study feasibility and site selection

• Site Selection and Activation

Clinical Project Management – Communication between sites, CROs & Patients, Investigators, Clinical Trial Teams

• Importance of effective communication between sponsor - CROs – sites

• Establishing long run relations between the site

Risk/Centralised Monitoring

• Effect on quality of the trials

• Impact on patient recruitment

Evaluating the Study budgets

• Minimizing the unpredictable environment on budget perspective or business perspective

• Minimizing the confusions between sponsors & physicians/sites/labs

• How to stay ahead with study budgets in competitive environment

KPIs - Speed, Cheap & Quantity

Patient Recruitment and Retention

• Future of patient recruitment in 2015 and beyond

• Relationship management in recruitment and retaining of the patients

• How and why current industry is driven by patients

• Site staff motivation

• Monitoring plan triggers related to the patient R&R

• How to maximize study participation

Effectiveness Questionnaire and Data Management

• Setting up effective questionnaire and dividing a study feasibility questionnaire

• Privacy and security of personal health information

Clinical Trial Data Capture – balancing quality, speed and cost

Clinical Outcome Assessments/ePRO (electronic Patient-Reported Outcome) Methods

Successsfully Implementing Global Clinical Trials using eCOA

Paediatric Clinical Trials: why are they different?

Outsourcing strategies - Patient recruitment challenges when studies are outsourced

Implementation of Business Models in Clinical Trials – Patient Recruitment and Retention

Engagement of Investigators in Business Models or Clinical Trial protocols

Social Media in Patient Recruitment - Facebook, blogs, SMS & Advertisement through Online Communities

• What role can social media play in improving patient enrolment through clinical sites?

• Patient attitudes and best practices in the social media recruitment space

• Driving the patients traffics from other websites, blogs, community sites to Pharma companies local websites

Digital strategies within the Patient recruitment and retention

Regulatory/Government Support and Strategy

Best Models for Site Operations

Latest trend in Clinical Trials and importance of technology in patient recruitment

• Use of Smartphone apps are increasing in popularity

• Testing a cheaper way to do clinical research

• How to translate technology/databases knowledge into identification of patients and attracting them to clinical trials – current challenges and opportunities

• Involvement of new technology in forecasting the result of the clinical trials

Patient Recruitment in Emerging countries and Challenges for Global Trials

• Challenges for Global Trials and changing regulatory environments

• Innovative Ideas for Global Patient Recruitment



Session I 9:15hrs

Risk Based monitoring – Its impact on Patient Recruitment Jo Burmester, Director Global Operations, PharmaSchool Ltd.

Session II 10:00hrsPaediatric Clinical Trials: why are they different?Philippe Auby, Divisional Director Paediatrics and CDC, Lundbeck• New Regulatery Framework• Recruitment Challenges• Case Study: Psychopharmacology Case Studies

10:45hrs Networking Tea & Coffee with Continental Breakfast

Session III 11:15hrsHow online patient-centric platforms will transform the way clinical trials are done Kai Langel, Founder and Director, eClinical Health

Special Feature 12:00hrsInsight on: Informed consent - it’s role in subject recruitment and retention Jo Burmester

Interactive Discussion 12:30hrs• How much information should we really be giving patients?• Do we make our protocols too restrictive?• Would you personally take part in a clinical trial?• What are the ethical issues with recruiting patients in developing

countries?Panellists: Philippe Auby, Rosamund Round, Pieter Proot, Urban Olsson

13:00hrs Complimentary Lunch Session IV 14:00hrs Enrolment and Retention in a Large Diabetes Study Pieter Proot, Senior Global Trial Leader, Novartis

• Enrolment challenges & how to manage them• Use of generated data to enhnace enrolment in the study• Retention Strategies• Case Study: Type 2 Diabetes Study(Long-Term)

Session V 14:45hrsUsing online tools to accelerate clinical trial recruitment Pete Chan, Chief Innovation Advocate, Tudor Reilly Health

• Digital trends, the rise of the epatient and a key tipping point in how patients receive information about clinical trials

• How pharmaceutical-sponsored disease awareness and clinical trial websites can accelerate patient recruitment; lessons from recent online recruitment programmes in mental health

• Advantages of independent online health communities versus pharma-sponsored sites

• How big data can transform the planning and implementation of clinical trials; highlights from Tudor Reilly Health’s ePatient InsightsTM analysis in non-small cell lung cancer; how to reach epatients in a digitally smart way

• Case Study: PracticalAlzheimers.com, Hepatitiscnews.com

15:30hrs Networking Tea & Coffee with Bakery Delights

Session VI 16:00hrsGlobal Clinical Studies, Patient Recruitment Challenges and Observations Urban Olsson, Clinical Development Manager, AstraZeneca • Clinical Project Management• Clinical Outcome Assessments/ ePRO methods• Patient Recruitment in Emerging Countries and Challenges for

Global Trials

Session VII 16:45hrs – Special FeatureInsight on: How and why current industry is driven by patients Rosamund Round, Associate Director Patient Recruitment, Parexel International• Changing Environment• Advocacy Group Movement• Online Communities

Session VIII 17:05hrs Overcoming Challenges in Emerging MarketsYamin Mo Khan, Executive Vice President Clinical Development, Pharm-Olam• Should we conduct trials in THEK regions?• Abundance of Patients - A good thing?• Logistical, Legal and Financial Hurdles Open Discussion Panel 17:35hrs Closing Remarks by Jo Burmester, Director Global Operations PharmaSchool Ltd 18:05 hrs

18:10hrs Cocktail ReceptionAll attendees are welcome to join at the complimentary cocktail reception. An extended opportunity to network and benchmark.

DAY 1

8.15 - 9.00 Registration/ check in with tea and coffee Opening Remarks by Chair – Jo Burmester, Director Global Operations, PharmaSchool Ltd & Editor The Journal of Clinical Research & GCP



Session IX 9:15hrsClinical Project Management and Sponsor Oversight Dr Ulrike M. Grimm, Vice President, Global Clinical Operations, Vifor Pharma• KPI’s-benchmarks-dashboards• Implementation of efficient communication processes• Risk Management• Escalation Process

Session X 10:00hrsSuccesssfully Implementing Global Clinical Trials using eCOAWolfgang Summa, Vice President of outcomes delivery and support, ERT• Collecting your eCOA data on a Global Scale• Picking the right technology solution for your trial based on

Ptaient population, IT infrastructure of participating countries, validation status of used instruments(Linguistic and Modality)

• Global Support: Translations/Linguistic validation, Submission of Ethics committees, Logistics / Hardware, Training, Helpdesk

10:45hrs Networking Coffee Break With Continental Breakfast Session XI 11:15hrs KPI’s – Speed, Cheap & Quality Michaela Kroeger, Performance & Metrics Lead, Global Clinical Operations, Merck Serono

Session XII 12:00hrs Improving Clinical Study Site ProductivityAleksandra Jankielewicz, Clinical Director, Head Europe North/Central/East Site Management & Monitoring, Abbvie

Interactive Panel Discussion 12:45hrs• Will Risk Based Monitoring be good or bad for patient

recruitment?• Is it ethical to use social media to recruit patients?• How can we get the balance between encouraging recruitment

and coercing patients or encouraging fraud?• Why do patients withdraw from clinical trials?

Panellists: Ulrike Grimm, Aleksandra Jankeilewicz, Pete Chan

13:15hrs Complimentary Lunch

Session XIII 14:15hrs Future of Patient Recruitment: Meeting the needs of Patient Rosamund Round, Associate Director Patient Recruitment, Parexel International• Embracing Technology• Enhancing communication• Exploring other industries

Session XIV 15:00hrsTitle: Clinical Development PlanFormer Clinical Operations Director, Spain

15:45hrs Networking Coffee Break With Bakery Delights

Session XV 16:15hrs Patient Empowerment in Clinical TrialsJolanta Ewa Bilinska, Head of Dept. Int. Cooperation health Fund Lodz, International Alliance of Patients Organizations

• Mission and Vision of IAPO - how to empower patients• The proper information for patients about clinical trials• How to raise awareness about clinical trials

Special Feature 16:45hrsOpen Round Table Discussion to summarize the information learned through out the 2 days conference to raise final questions and comments.

Closing Remarks 17:10hrsJo Burmester, Director Global Operations PharmaSchool Ltd

17:30hrs Cocktail ReceptionAll attendees are welcome to join at the complimentary cocktail reception. An extended opportunity to network and benchmark.

DAY 28.15 - 9.00 Registration/ check in with tea and coffee Opening Remarks by Chair – Jo Burmester



Patient recruitment and retention offer major challenges to the clinical researcher with potential for significant impact on timelines, budgets, and ultimately the scientific integrity of the trial itself. Many factors affect the recruitment of patients and difficulty in finding suitable patients is driving the develop-ment of many innovative methods for accessing new patient groups. The rise of social media means that new technolo-gies and changing strategies for communication can be used to great effect to reach out to patients directly and through special interest groups, and to communicate with patients enrolled in clinical trials. How to maximise the benefit of this approach and ensure our regulatory obligations are appropri-ately met will be the subject of several sessions during the summit. Conducting trials in developing countries is becom-ing more common, because of the potential for large numbers of treatment naive patients and the willingness of healthcare

staff to learn about clinical research and work with sponsors. There are, of course, challenges with this approach and dur-ing the conference there will be opportunities to discuss the advantages and obstacles, and hear from colleagues working in these areas. Feasibility studies conducted before a clinical trial commences can identify risks associated with the trial in terms of patient recruitment and retention. Also the increasing emphasis of certain Regulatory Agencies on Risk Assessment and Risk Based Monitoring can serve to focus our attention on identifying risks to patient recruitment and therefore develop strategies to mitigate those risks. There will be sessions during the summit looking at getting feasibility right, performing risk assessment in a constructive way and considering the impact of on-site monitoring on patient recruitment and retention rates, and how to use this information in a risk based monitor-ing setting.

A word from the chairJo Burmester, Director Global Operations PharmaSchool Ltd and Editor The Journal of Clinical Research & GCP:

I am very pleased to be involved with this summit on an increasingly important area in the conduct of clinical trials. The development of new medicines can only continue if we can recruit patients to our trials and then keep them on board. In my time in the industry, working with pharmaceutical and biotechnology companies, CROs and non-commercial researchers, I have seen a dramatic rise in the regulation of clinical trials and also in public awareness of the advantages and risks of taking part in research as a patient. These changes offer challenges and opportunities which I look forward to exploring during the summit.

Conference Benefits:Opportunity to meet top expert and decision makers from Pharma, Biotech and CRO industry under one roof.

Venue BerlinA rewarding opportunity to visit Berlin, GermanyBerlin is a world city of culture, politics, media, and science. Its economy is primarily based on high-tech industries and the service sector, encompassing a diverse range of creative industries, research facilities, media corporations, and convention venues. Berlin also serves as a continental hub for air and rail transport and is a popular tourist destination. Significant industries include IT, pharmaceuticals, biomedical engineering, biotechnology, electronics, traffic engineering, and renewable energy. Berlin is home to renowned universities, research institutes, orchestras, museums, and celebrities and is host to many sporting events.

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2014 berlin_ operational excellence in clinical trails

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