DIA EuroMeeting 2014 Advance Programme now available ~ March 2014 in Vienna

DIA and the EuroMeeting 2014 Programme Committee have worked hard over the past month to present you with an outstanding conference programme. We invite you to view the Advance Programme today, and to begin planning your attendance in March. Let the Co-chairs tell you what will be special about this EuroMeeting and why you should come to Vienna in March Advance Programme Download the Advance Programme to find out more about themes, Theme Leaders, exhibition, hotels and travel.                 Programme Co-chairs Angelika Joos Head Regulatory Policy EU and Most of World, Merck Sharp and Dohme, Belgium Marcus Müllner Head, Austrian Medicines and Medical Devices Agency (AGES) EuroMeeting 2014 Topics of Global Relevance The links will take you directly to the right page of the programme Tutorial 9: Early Access Schemes: Considerations for developing regulatory strategies Tutorial 13: Clinical Trials in Emerging Markets: Fostering strategic relationships, building capacity and enhancing capability Session 0105: Biosimilars – Building on European foundations to achieve global harmonisation Session 0107: Optimising Regulatory Operations Through Use of Information Technology Session 1002: Surviving Safety and Quality Inspections in the Era of Globalisation: Harmonising systems and processes across company units Session 1005: Global Submission and Review Strategy – How rapidly Innovation can reach global markets Session 1007: Current Status and Future Challenges of Asian Regulatory Environment Session 1205: Quality by Design (QbD) and Innovation in Development and Manufacturing Session 1402: Innovation Through Public-Private Partnership Collaborations Session 1604: Regulatory Intelligence in Practice – How regulatory authorities inform about decision making Stand-Alone Session: Japanese Regulatory Session/PMDA Update

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Insights From Canada’s Thought Leaders on Patient’s Voice, Plain Language Labeling Project, Pharmacovigilance

Exclusive Scoop from Canada's Key Thought Leaders       In this edition of the Insider Update you’ll hear insights from Canada’s key industry thought leaders regarding the impact of patient’s voice in the ever changing regulatory environment, the emerging areas of change in Pharmacovigilance in Canada, and what international regulatory cooperation means to key stakeholders in the development and regulation of health products. In addition, we will address the need to provide the patient and the health care professional with increased accessibility to drug information and comprehension of drug labels, plus more.   “Those who are in the pharmaceutical industry and those in the regulatory realm need to acknowledge the patients’ voice and perspective." "New approaches and collaborations are required to keep up with the realities of the pharmaceutical industry today..." Get the Insider Scoop NOW!    Read More Insider Update

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Clinical Operations Track at DIA's 49th Annual Meeting

 

• What are the emerging challenges with patient registries? 
• What do you need to know about statistics?  Variability~confidence intervals~hypothesis testing~p-values
• What are the best practices in patient recruitment, budgets and contracts, and FDA audit readiness?
• How do you ensure data integrity with reduced expenditures on traditional 100% on-site monitoring and SDV?
• How do different enrollment metrics/analyses benefit different stakeholders (site/sponsor/recruiter)? 
• Do you know how to shape your cost with hard and soft coverage analysis trends?
• How can investigator sites pave the way for running successful Clinical Trials?
• Is this trial worth it? Finding answers for Site and Project Managers.
• How should you tailor existing patient recruitment programs to engage parents for Pediatric Trials?  
• How do you establish metrics for Optimal Patient Recruitment and Retention?  
• What global requirements are needed in the Informed Consent Process? 
• What are the Domestic and Global trends in Clinical Trial budgeting?  
• How can we use Big Data to design smarter clinical studies? 
• Can a mathematical algorithm used in point-of-care risk assessment id and screen Clinical Trial subjects?  
• How do you build Patient engagement to make Clinical Research better for everyone?  
• Learn to apply innovation, avoid controversy and implement best practices in Clinical Trials 
• How can site metrics be used to improve enrollment timelines?
• Can you identify Pharmacy-directed outreach and Patient  Recruitment strategies for your Clinical Trial? 
• What do you need to maintain regulatory compliance with continuously evolving import/export processes? 
• How do you solve key challenges to running efficient investigator meetings during Clinical Study startup? 
• What impact will FDASIA have on your need to recruit diverse clinical subjects?  
• What 4 pillars support comprehensive operational feasibility assessment for Clinical Trial planning?  
• Fed Up with tracking pointless Metrics? Learn how to select and use Metrics that work.  
• What are the challenges and requirements of implementing Central Statistical Monitoring? 
• What unique challenges are associated with pediatric trial recruitment, retention and blood sample collection?  
• What are the Diverse Operational Approaches to generating evidence in the Late-phase Environment? 
• What are the areas of potential risks when undertaking Global Clinical Trials in Emerging Markets? 

PCORI Board of Governors Meeting (Feb 4) and Health Affairs Briefing (Feb 6)

February 1, 2013 We'd like to let you know about two exciting events next week and how you can participate. Board of Governors Meeting On Monday, the PCORI Board of Governors will hold a public meeting in San Francisco. The meeting will take place 8:00 a.m. to 5:00 p.m. PT and will include a 30-minute public comment period at 2:30 p.m. Click here to register to provide comments during the public comment period. A webcast will be available for participants who cannot attend in person. Click here to register for the webcast. Monday, February 4 8:00 a.m. - 5:00 p.m. PT At the meeting the Board will review our plans to develop funding announcements on a set of specific high-impact research topics. We have identified five such topics to consider for an initial round of Targeted PCORI Funding Announcements: treatment options for uterine fibroids; treatment options for severe asthma in African-Americans and Hispanics/Latinos; preventing injuries from falls among the elderly; treatment options for neck and back pain; and obesity treatment options in diverse populations. Additional Board business includes reports on: PCORI Advisory Panels. PCORI's strategic plan. An ongoing evaluation of PCORI's research funding application review process. PCORI's conflict of interest policy. For more information, including an agenda, presentations, a link to the workshop webcast, visit the PCORI website. Health Affairs Briefing On Wednesday, PCORI will join Health Affairs for a briefing to discuss its February 2013 issue, "New Era Of Patient Engagement."PCORI Executive Director Joe Selby, MD, MPH will speak at the briefing on how PCORI is engaging patients and stakeholders in shaping its research agenda. Wednesday, February 6 8:00 a.m. - 2:30 p.m. W Hotel Washington, 515 15th Street NW, Washington, DC Click here for more information Follow @PCORI and @HA_Events on Twitter for live coverage of the briefing.

Patient-Centered Outcomes Research Institute | 1828 L Street, NW | Suite 900 | Washington | DC | 20036

25th Annual DIA EuroMeeting - Session Overview - 5-6 March 2013 Amsterdam

Session Overview - March 5 & 6
RAI Center
Europaplein
1078 GZ Amsterdam
Netherlands

Accepting onsite registrations!


The themes for the EuroMeeting 2013 include the professional disciplines of regulatory affairs, safety and efficacy for human medicines, diagnostics and devices. Much innovation will be fostered by interaction between disciplines and jointly between the stakeholders of healthcare innovation such as industry professionals, academia, regulatory competent authorities, patient representatives, and the general public.

Theme 1 | Health Technology Assessment (HTA)/Sustainability of Health Systems in EuropeLuca De Nigro, Coordinator, Drugs Monitoring Registers Unit, Italian Medicines Agency, Italy
Lidia Retkowska-Mika, Head Legal Unit, Office for Registration of Medicinal Products, Poland

Theme 2 | Development of Medicinal Products for Paediatric, Elderly and other Special Populations
Gesine Bejeuhr, Regulatory Affairs/Quality, vfa Research-Based Pharm Companies, Germany
Markus Pasterk, COO and VP of Science, International Prevention Research Institute, France

Theme 3 | Legal/Transparency/Risk & Litigation
Burkhard Sträter, Lawyer, Kanzlei Sträter, Germany
Theme 4 | PharmacovigilanceVicki Edwards, Senior Director, European Pharmacovigilance, Abbott, UK
Jan Petracek, CEO, Director of Pharmacovigilance Services, Pharminvent, Czech Republic

Theme 5 | Clinical Research and DevelopmentAndrei Kravchenko, Head of Office, Harrison Clinical Research, Ukraine
Nermeen Varawalla, Founder and CEO, ECCRO, UK

Theme 6 | Quality (including Falsified Medicines)Susanne Keitel, Director, European Directorate for the Quality of Medicines and Healthcare (EDQM), Council of Europe, EU
John Kerridge, Quality Leader, EU QA External Relations, Lilly, France

Theme 7 | Devices & In Vitro Diagnostics and Combination ProductsShayesteh Fürst-Ladani, Managing Director, SFL Regulatory Affairs and Scientific Communication, Switzerland
Siniša Tomić, Counselor for European Affairs, Agency for Medicinal Products and Medical Devices, Croatia

Theme 8 | eHealth
Hans van Bruggen, Director, eCTDConsultancy, Netherlands
Rob Middel, Head of R&D Business Development, Pharmaceutical R&D Quality & Compliance, Senior Director Janssen Biologics, Netherlands

Theme 9 | Involvement of Patients and Academia as Experts in the Drug Approval ProcessGonzalo Calvo Rojas, President of the European Association for Clinical Pharmacology and Therapeutics (EACPT), Spain
Judith Creba, Head EU Liaison & Policy, Novartis, Switzerland

Theme 10 | Known Active SubstancesMaren von Fritschen, Director Regulatory Affairs, PharmaLex, Germany
Marta Marcelino , Member CMDh, Medicines Evaluation Department, National Authority of Medicines and Health Products (INFARMED), Portugal

Theme 11 | Antiobiotics/Anti-Infective TreatmentsRichard Bergström, Director General, European Federation of Pharmaceutical Industries and Associations (EFPIA), Belgium

Theme 12 | Effectiveness and Efficiency of the EU Regulatory system - Does new legislation enable innovation and facilitate co-operation?Isabelle Stöckert, Head Global Regulatory Affairs Europe/Canada, Bayer Healthcare Pharmaceuticals, Germany
Melek Bostanci Önol, Head of Regulatory Affairs & Quality Assurance, Boehringer Ingelheim, Turkey

Theme 13 | GlobalisationChrister Backman, Member CMDh, EU Coordinator and Senior Expert, Medical Products Agency, Sweden
Ning Xu, Executive Director, Head of CDS, Covance Pharmaceutical R & D, China

Theme 14 | Regulatory ScienceChristine Gispen-De Wied, Clinical Coordinator; Member of SAWP, Medicines Evaluation Board (MEB), Netherlands
Hubert Leufkens, Chairman, Medicines Evaluation Board (MEB), Netherlands

Theme 15 | Growing Demand for Quantitative Approaches in Drug DevelopmentJürgen Kübler, Global Head, Clinical Sciences, CSL Behring, Germany
Steven Teerenstra, Statistical Evaluator, Medicines Evaluation Board, Biostatistics Working Party (BSWP), Netherlands

 

Theme 16 | Non-Clinical
Jan Willem van der Laan, Senior Pharmacological Toxicological Assessor, Medicines Evaluation Board (MEB), Netherlands

Theme 17 | The IMI Public-Private Partnership in Medicines Research Education and Training – for Professionals and for PatientsHans Lindén, Leader European Projects , European Federation for Pharmaceutical Sciences (EUFEPS), Sweden

See also:
Searchable Program
List of Program Committee Members

PCORI's Patient-Researcher Matching Challenge webinar Jan. 28

January 24, 2013

Would you like to help connect researchers and patients interested in partnering to design and conduct patient-centered comparativeness research studies? We at the Patient-Centered Outcomes Research Institute hope so. And we have a way for you to do just that.

Join us on Monday, January 28, at 12:00 pm - 1:00 pm for a webinar exploring PCORI's Patient-Researcher Matching Challenge. We announced this initiative in December with $50,000 in prize money for applicants who submit the best concept or prototype for a system connecting researchers and patient partners interested in pursuing rigorous patient-centered outcomes research. We are undertaking the challenge in collaboration with the San Francisco-based company Health 2.0. The webinar will provide an overview of the challenge and let potential applicants pose questions to me and to our Director of Communications, Bill Silberg. Our approach to research is neither traditional nor simple because it requires sustained and meaningful engagement with patients, caregivers and other stakeholders. We know many researchers are interested in adopting this approach and seek funding from us, but don't necessarily know the best or most effective way to proceed. Likewise, many patients are interested in working with researchers, but are unsure of how to make the connection that will allow them to participate. The PCORI Challenge offers an opportunity for innovators to help researchers and patients connect, and help PCORI fulfill our commitment to "research done differently" by bringing together in collaboration the many voices that represent our diverse healthcare community. Applicants may consider submitting a well-articulated conceptual model, adaptation of an existing matching protocol reimagined for the purpose outlined in this challenge, a prototype for an entirely new web-based service or app, some combination of these approaches, or something else entirely. Winners of the challenge will receive cash prizes and their work may be considered for additional PCORI support. We thank you for your continued interest in our work and encourage you to register for the webinar to learn more about this exciting approach to problem-solving.

Thank you. Sue Sheridan, MIM, MBA Director, Patient Engagement