Move Toward Better Communication and Collaboration Among Patients, Payers, and Product Developers

Move Toward Better Communication and Collaboration Among Patients, Payers, and Product Developers Share   DIA and the Brookings Institution are collaborating to strengthen communication between health care stakeholder communities. A Model of Patient, Payer, and Product Developer Collaboration to Support Innovating for Value will focus on highlighting the perspectives and outcomes most relevant to patient communities, reimbursement requirements and innovative payment models of most interest for payer groups, and how both can help inform product developers as they drive toward novel value-based innovation. By exploring these issues and setting an actionable agenda for improving communication moving forward, this conference will be an important step toward ensuring that patients, payers, and product developers are each contributing to the creation of cost-effective, quality-producing therapies. DIA Members Save $100. Register by October 9!    Overview | Register Today Session Topics:      • Aligning Perspectives on Value and Outcomes      • Identifying Stakeholder Needs and Challenges to Strategic Communication      • Exploring Opportunities for Efficient Engagement Throughout Discovery,        Clinical Development, Regulatory Review, and Product Use      • Case Studies and Current Initiatives      • Next Steps: Charting a Course Forward      • And More Keynote Speaker:      • James Heywood, Co-Founder, Chairman, PatientsLikeMe Confirmed Speakers:      • Anne C. Beal, MD, MPH, Chief Operating Officer, Patient-Centered Outcomes Research Institute      • Marc M. Boutin, JD, Executive Vice President and Chief Operating Officer, National Health Council      • Shari M. Ling, MD, Deputy Chief Medical Officer, Centers for Medicare & Medicaid Services        Center for Clinical Standards & Quality      • Sean R. Tunis, MD, MSc, President and CEO, Center for Medical Technology Policy      • Rhonda M. Medows, MD, FAAFP, Executive Vice President & Chief Medical Officer        UnitedHealthcare      • Tehseen Salimi, MD, Vice President of Global Evidence and Value Development, Sanofi Aventis      • Frances M. Visco, President, National Breast Cancer Coalition      • Reed V. Tuckson, MD, FACP, Managing Director, Tuckson Health Connections, LLC Who Should Attend?      • Patient groups interested in strengthening patient involvement in medical product development      • Payer groups involved in reimbursement for innovative new products      • Product developers considering the role of external stakeholders in the creation of cost-effective,        quality producing medical products      • Regulators, providers, and academic researchers pursuing cross-sector collaboration to        improve health care stakeholder communication Co-sponsored by:             More Exciting Offerings: US Conference on Rare Diseases & Orphan Products: The New Era in Health Care October 7-9 | North Bethesda, MD Co-sponsored with National Organization for Rare Disorders The annual conference where all stakeholders in the rare disease/orphan product community convene to focus on rare diseases and orphan product research, development, and access. Search the Online Program. Beginning with the End in Mind – Study Endpoints: Targeting Patient-Centered Outcomes October 21-23 | North Bethesda, MD | Register by September 30 and Save up to $200! Gain insight into the tradeoffs and various stakeholder perspectives for developing a study endpoint measurement strategy, including detailed and practical tips for ensuring that measurement tools are adequate to support the targeted objectives with a focus on establishing instrument content validity for the specified clinical trial context of use. Benefit-Risk Assessment from Inception to Maturation: Aligning Regulatory and Industry Goals February 10-14 | Bethesda, MD Join FDA, EMA, Health Canada, and other regulatory agencies, patient, industry and academic representatives to discuss the progress and application of Benefit-risk assessment throughout the development and post-approval life cycle.

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Clinical Project Management Training course Mexico City on November 7

Get the Latest Expert Advice in Managing a Clinical Trial There’s just one month to go until the Clinical Project Management Training course, to be held in Mexico City, Mexico on November 7. Attend this training course to learn how to define the scope of interventional and observational clinical studies, evaluate the main requirements, and identify suppliers for the feasible conduction of a clinical trial. Participants will also develop an understanding of the global regulatory framework and its application to accomplish a successful clinical study. Find out More Download Program Register Session highlights: Drug Development Global Regulatory Framework Clinical Studies in Latin America Role of the Study Manager Clinical Study Management Clinical Data Management Safety Find out More Download Program Register

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The Electronic Trial Master File: So Much More than Just a Secure Document Repository

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Register for this FREE Solution Provider Webinar

The Electronic Trial Master File: So Much More than Just a Secure Document Repository
September 17 | 1:00-2:30 PM ET
Brought to you by DIA in cooperation with NextDocs

Implementing an electronic Trial Master File (eTMF) is becoming a standard business model for the clinical industry. The benefits of moving to an eTMF have been well documented, e.g. increased TMF quality, efficiency, and access to all stakeholders. However, there are additional benefits when considering the move to an eTMF, such asthe benefits gained from leveraging the data within the eTMF.

This FREE webinar will demonstrate how to leverage data to maximize the potential of an eTMF. Presenters will include Sharon Ames, Enterprise Program Director at NextDocs Corporation, and Gabor Fari, Director of Life Sciences Solutions at Microsoft Corporation.

Featured topics:

• Using eTMF Data to Define and Measure Key Performance Indicators and Operational Metrics
• Search vs. Findability – Obtaining Quick and Thorough Query Results
• Using Interoperability and Standards for Streamlining the Clinical Trial Process
• Ensuring the Availability of Data through Recommended and Mandatory Metadata

Who Should Attend? Professionals involved in:

• Coordinating and Managing Clinical Trial Operations for Drug Development in Sponsor or CRO Organizations
• Optimizing Clinical Trial Business Processes
• Administering and Reconciling TMF Records
• Overseeing Regulatory Compliance and Audit Readiness for Clinical Trials
• Maintaining IT Infrastructure for Clinical Trials

Overview | Register Online for FREE!

DIA2013 offers a custom-fit leadership approach for women in middle-management RA and legal functions.

The DIA - HBA Skill Building Series: A Custom-Fit Leadership Approach for Women in the Regulatory, Medical, Legal and Compliance Functions

This interactive workshop will be held June 23 from 1:00 - 6:00PM in Boston, MA and is designed to improve leadership agility and performance. You will learn how executives in these functions express their value and will work with tools to help them identify and articulate their own unique value to their business partners within the pharmaceutical, biotechnology, and medical device industry. The new insights and leadership skills gained at the workshop will be immediately applicable in the work setting.

Instructors:
Welcome & Opening Remarks
Minnie Baylor-Henry, JD, RPh, DIA President Elect
Worldwide Vice President, Regulatory Affairs
Johnson & Johnson Medical Devices & Diagnostics

Session 1: Industry Trends and Key Criteria for Business Success in Today’s Environment

Session 2: Business Acumen: Framing Your Role with a Business Context
Ilyssa Levins, Winner of HBA President’s Award and Rising Star
President
Center For Communication Compliance (CCC)

Session 3: Moving from Technical to Strategic Thinking
Catherine Angell Sohn, PharmD, HBA Women of the Year
Dean's Professor; President, Sohn Health Strategies LLC
University of the Sciences

Networking Break

Session 4: Commanding Executive Presence
Karen Hough, Nationally Recognized Author
Founder and CEO
ImprovEdge, LLC

Session 5: Working with or as a Mentor
Hayley A. Norman, Author and Former Pharmaceutical Executive
Managing Member
Metajourn, LLC

What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.

Visit www.diahome.org/DIA2013 for more details on the DIA 2013 Annual Meeting being held June 23-27 in Boston, MA.

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Take advantage of DIA’s live webinars

Stay ahead in your field with DIA's live webinars
Take advantage of DIA’s live webinars to learn about the latest issues in your field. Upcoming webinars include:

• Eight-Part Webinar Series: Assessing the Benefits and Risks of Medicines, Part 5: Stated Choice Methods for Valuing Benefits and Risks (April 24, 11:00 a.m. - 12:30 [p.m. ET)
• Two-part Webinar Series: Impact of the New European Pharmacovigilance Legislation and Important Updates (April 25 and 26, 10:00 a.m. - 11:30 a.m. ET)
• Using Patient-Reported Outcomes to Assess Product Safety and Tolerability: Methodological and Regulatory Considerations (May 17, 11:00 a.m. - 12:30 p.m. ET)

View more upcoming webinars.

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Oportunidades de Capacitación para Mejorar su Desarrollo Profesional

La DIA, entiende  que a la vez que usted cumple con sus ocupaciones necesita mejorar sus habilidades y mantenerse actualizado sobre las novedades de la industria-- todo dentro de su horario de trabajo. Es por eso que la DIA ha creado Programas de Certificación que ofrecen instrucción interactiva impartida por expertos en el ramo, conveniente para su campo laboral.   Los Programas de Certificación de la DIA ofrecen capacitación real que fomente su desarrollo profesional. Muchos de nuestros programas ofrecen créditos de educación continua y Certificados de Terminación expedidos por la DIA.   Los Programas de Certificación se ofrecen en cuatro áreas clave. Haga clic en su campo de su interés para obtener más información sobre el programa a la medida que le interese: Seguridad Clínica y Farmacovigilancia Gestión de proyectos Asuntos Regulatorios Investigación Clínica Otros Eventos Programa de Certificación en Seguridad Clínica y Farmacovigilancia Instructores de clase mundial de la DIA abordan aspectos teóricos y prácticos sobre la aplicación de la farmacovigilancia, con  un enfoque especial  en la comprensión de temas que abarcan desde procesos efectivos hasta los principios básicos del cumplimiento de normas regulatorias internacionales, así como los principios de seguridad. Temas principales: Pre y post-mercadeo en seguridad clínica y farmacovigilancia Estrategias de gestión de riesgo Cómo prepararse para una inspección de seguridad Enfoque médico en diagnóstico y tratamiento de las reacciones adversas a los medicamentos Señal de detección y gestión de datos Vigilancia del Manejo Seguro de Medicamentos y epidemiología   Descargar Requisitos del Programa     Formulario de inscripción   Programa de Certificación sobre Gestión de Proyectos El Programa de Certificación de Gestión de Proyectos de DIA le ofrece una amplia selección de cursos que ayudarán a los profesionales a reducir los tiempos de los ciclos de desarrollo de productos, a mejorar la calidad del producto y asegurar su rentabilidad. Temas principales: Retos actuales en la gestión de proyectos Planificación y gestión de proyectos Programación, recursos y manejo de costos Construcción de equipos y comunicaciones Gestión de riesgos Paradigmas para el desarrollo de fármacos   Descargar Requisitos del Programa     Formulario de inscripción   Programa de Certificación en Asuntos Regulatorios Este programa le proporciona una formación integral en la normativa vigente y su aplicación práctica para su desarrollo, comercialización de productos farmacéuticos, biotecnología, dispositivos médicos y productos relacionados con el cuidado de la salud.   Temas principales: Asuntos regulatorios de los EE.UU: las fases IND y NDA Requisitos regulatorios de los EE. UU. Preparación para los encuentros con la FDA Requisitos Regulatorios Post- Aprobación Requisitos reglamentarios para el etiquetado y publicidad de productos Cursos de regulación que cubren lo relativo a medicamentos, dispositivos médicos y productos biológicos Control de calidad   Descargar Requisitos del Programa     Formulario de inscripción   Programa de Certificación sobre Investigación Clínica Instructores de clase mundial de la DIA ofrecen un plan de estudios único que combina los principios de negocio, la comprensión de las buenas prácticas de investigación clínica, así como también el desarrollo de las habilidades necesarias para enfrentar los cambiantes escenarios políticos, regulatorios y financieros. Temas principales: Buenas prácticas clínicas Fundamentos de Investigación clínica y seguimiento Estadísticas clínicas para personal no familiarizado Gestión de proyectos clínicos Elaboración de reportes sobre estudios clínicos   Descargar Requisitos del Programa     Formulario de inscripción   ¿Desea llevar a su empresa un entrenamiento In-company? Permita que la DIA le diseñe el programa de capacitación in-company (en su sitio de trabajo) adecuado, una experiencia de formación que le permita alcanzar objetivos y metas específicas, todo esto a la medida del presupuesto y calendario de su organización. Vaya a www.diahome.org/Incompany; llene una forma de consulta o llame a Alejandro Bermudez-Del Villar al Telefono +1.215.293.5825 o por correo electrónico Alejandro.Bermudez@dialatinamerica.org

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