Operational Excellence in Clinical Trials. Summit. Overview. 9 th 10 th March 2016 Berlin, Germany

Transcription

1 Operational Excellence in Clinical Trials #OECT14 Operational Excellence in Clinical Trials Summit Study Feasibility & Patient Recruitment Retention 9 th 10 th March 2016 Berlin, Germany Overview 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. Study Feasibility and Patient recruitment & 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 development of many innovative methods for accessing new patient groups. How the Big Data can have a significant impact in clinical trials. The rise of social media means that new technologies and changing strategies for communication can be used to great effect to reach out to patients directly. Additionally outreach through patient advocate groups, social service agencies are becoming more important to communicate with patients viable for trial participation as well as for those already enrolled in clinical trials. How to maximise the benefit of this approach and ensure our regulatory obligations are appropriately met will be the subject of several sessions during the summit. 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. Join our successful summit, raise your challenges, and exchange your experience with the top experts from the industry.

2 Two Days Topics at a Glance: Insights, key presentations, panel discussions, demos, live case studies, and debates on the topics 9 TH MARCH - DAY ONE 8:35hrs Registration/ Check-in with morning tea/coffee Section One Disruptive Technology and Data Management Patient Centric Approach to data Management Big Data - Pharmacy data, prescription records, heat maps, trial result database Role of Electronic Patient Reported Outcome and PRO in Clinical Trials Clinical Trial Data Capture balancing quality, speed and cost Importance of Cloud Technology in Clinical Development Wearables and Growing involvement of Mobile Health in Clinical Trials Challenges and Best Practices in eclinical Trials Involvement of new technology in forecasting the result of the clinical trials Technology Advances in Patient Recruitment How to translate technology/databases knowledge into identification of patients and attracting them to clinical trials Interactive Panel Discussion: All attendees will have an opportunity to get interact directly with the members of the panel to discuss a selection of the most interesting topics addressed during the conference. 12:30hrs Complimentary Lunch Break Section Two Identifying Challenges and Managing Risk: Study Feasibility, Site Management and Patient Enrollment Clinical Project Management Communication & relationships between sites, CROs, investigators and sponsors Changing Roles of Clinical Project Managers Practical approach to site selection, process timing and activation How to improve the study conditions and site performance Identifying, Screening and qualifying investigative sites Improving Clinical Study Site Productivity and how to motivate Site Staff Best Models for Site Operations Evaluating Study Budgets How to deliver clinical studies on-time and within budget Complexity of sponsors SOPs and Protocols Additional sponsor requirements How to establish long run relations between the sites How to determine rate capacity and speed of enrollment Investigator meetings How to structure them correctly Operational Risk and Competitive Risk How to develop a global strategy for enrollment Effect of Risk Based and Centralised Monitoring What would make a patient willing to participate in a trial? Special Insights: A focus on Oncology Trials and Long run trials Section Three Clinical Research Strategy and Patient-Centric Approach Role of Patient Advocates and Patient Advocacy Patient Centricity and Patient Engagement How emphasize on patient understanding Patient empowerment and impacts of Patient Centric approaches Holistic approach: Incorporate Patient Centricity Importance of Patient Centricity in Clinical Trials Incorporating patient advocacy into the clinical matrix Communication between stakeholders Patients are KOLs too Influence of epatient and Patient Advocacy Patient Involvements in CT Evolving business models in Clinical Trials Open Round Table Discussion and Daily Wrap up Session: Open Round Table Discussion to summarize the information learned throughout the day one of the conference to raise additional questions and make comments. 18:00hrs Cocktail Reception: All attendees are welcome to join at the complimentary cocktail reception. An extended opportunity to network and benchmark

3 10 TH MARCH DAY TWO 8:35hrs Registration/ Check-in with morning tea/coffee Distinct Feature: A success story Paediatrics Trials Section Four Best Practices & Latest Trends - Patient Recruitment & Patient Retention Patient Recruitment Strategies Innovative Ideas for Global Patient Recruitment Intelligent Patient Recruitment Multi-channel Recruitment New trends of recruitment campaigns Pharma 2020 Future of Patient Recruitment Regulatory and Legislative Challenges in patient recruitment Systems to manage retention Retention Strategies How to retain the patients in Long run studies and Mega Trials Successful patient recruitment techniques Challenges when studies are outsourced Globalization of Recruitment Innovation Emerging Markets Perspective Interactive Panel Discussion: All attendees will have an opportunity to get interact directly with the members of the panel to discuss a selection of the most interesting topics addressed during the conference. Section Five Social Media in Patient Recruitment - Blogs, SMS, Facebook & Advertisement Through Online Tools Patient attitudes and best practices in the social media recruitment space Patient Recruitment online tools Patient attitudes and best practices Role of Social Media in Clinical Trials Digital Evolution New ways to achieve digital excellence Overcoming Clinical Trial Marketing Challenges Driving the patients traffics from other websites, blogs, community sites to Pharma companies local websites Understanding that all Social Media is not on the Internet What role can social media play in improving patient enrollment through clinical sites? Open Round Table Discussion and Daily Wrap up Session: Open Round Table Discussion to summarize the information learned throughout the 2 days conference to raise final questions and comments. 17:30hrs End of the two days conference with Closing Remarks by Chair 13:00hrs Complimentary Lunch Break Who will you meet? Got a question? Chiefs, Directors, Heads, Senior Managers, Leads and Executives from: Clinical Operations, Clinical Developments/Research, Clinical Trials, Clinical Program, Clinical Project Management, Study and Feasibility Management, Global Monitoring Operations, International Clinical Research, Patient Recruitment & Retention, Medical Operations, Medical Affairs, Medical Advisors, MSL, Data Management, Patient Advocacy, Patient Communities, Strategic Marketing, Compliance and Regulatory Contact Mr Andreas Raab Andreas.Raab@kp-morgan.com Telephone: Linked Group: Operational Excellence in Clinical Trials Twitter: #OECT14

4 A rewarding opportunity to visit Berlin Berlin 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. Be a part of the notable thought leaders and challenging executives who are perfecting the practice of study feasibility, site management, patient recruitment & retention, and bring the new ideas back to your organisation. Conference Benefits Opportunity to meet top expert and decision makers from Pharma, Biotech and CRO industry under one roof. The two days international forum consists of 20+ sessions. More than 10 Case Studies presenting by the top experts from the industry, Networking Breaks, Benchmarking Opportunities, Daily Wrap-ups, Round Table Discussions, Panel Discussions, One-to-one interactions, Cocktail Reception. and much more! YEAR 2015 Speakers at glance: Jo Burmester Director Global Operations, PharmaSchool Ltd Kai Langel Founder and Director, eclinical Health Pete Chan Chief Innovation Advocate, Tudor Reilly Health Philippe Auby Divisional Director Paediatrics and CDC, Lundbeck Dr Ulrike M. Grimm Vice President, Global Clinical Operations, Vifor Pharma Yamin Khan Executive Vice President Clinical Development, Pharm- Olam Frank Verheggen Clinical Program Management Director, Astellas Nan Brinchmann Hildebrandt Associate Director Clinical Research, GCTO Europe, Merck (MSD) Elizabeth Coxon Director, ClinicalDevelopment Programs, Ipsen Magnus Dahl, Clinical Development Manager,, AstraZeneca Virgil H. Simons Founder & President, The Prostate Net Europa Sjaak Vink CEO, mytomorrows Bettina Bergtholdt Managing Director & Principal Investigator Emovis Savitha Ram Moorthi Director Clinical Operations Europe, Novo Nordisk Magdalena Margasinska- Brach Senior Project Manager Premier Research Group Mike Ryan Chief Business Officer Longboat Pilar de la Rocha Mur Head of Planning and Operational Excellence Novartis Pernilla Sandwall Chief Operating Officer, Index Pharma Anna Gibernau Senior Global Project Manager, MedSIR Tomasz Kosieradzki Quality Assurance Advisor Polpharma Karsten Roth Director Clinical Operations Cinfa Biotech Olga Maria Martinez- Casares Head Clinical Research Strategy & Patient Advocacy, GSK Rasmus Hogreffe Patient Recruitment Specialist, i-recruit Suzanne Pozsonyi, Local Enrollment Specialist, Regional Manager CSSi Enroll Richard Burrell Director Business Development, Charité Research Organisation And many more!!!

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