Navigate Your Way to Success at the Largest Life Sciences Meeting in the Region - DIA2013

Navigate Your Way to Success at the Largest Life Sciences Meeting in the Region We want to make your DIA 2013 49th Annual Meeting experience a breeze. Navigating through more than 250 educational offerings across 22 tracks can be overwhelming to select the sessions that best fit your needs. We have provided a tailored schedule for Clinical Safety and Pharmacovigilance Professionals. We did the work for you! What’s more, bring your colleagues or your whole team - divide and conquer - with so many exceptional sessions, spilt the sessions and benefit from more at DIA 2013 49th Annual Meeting. Contact our Group Discount Representative for details! Don't miss out on this opportunity to meet with people from around the world, share your views and knowledge, network, and build new relationships with the greatest educational offerings under one roof. Lead the Way to Expedite Products to Market! Monday, June 24 Electronic Health Records (EHRs) in Signal Detection and Evaluation 11:00AM-12:30PM ET This session will provide and in-depth update on various initiatives that have been launched worldwide to investigate the uses of electronic health records (EHRs). Narrative Medicine and Pharmacovigilance 11:00AM-12:30PM ET In recent years, pharmacovigilance has emphasized the collection and submission of tabular data. Using ideas from narrative medicine, we can re-focus on the patient’s story to better understand adverse drug reactions and Benefit-risk balance. European Town Hall: Implementation of New Safety Legislation and Other Hot Topics 11:00AM-12:30PM ET Get the first experiences with the new PRAC and how the PRAC interacts with the different EU committees (such as the CHMP and CMDh). The New Standards for the Identification of Medicinal Products and Individual Case Safety Reporting Applied in Pharmacovigilance 2:30-4:00PM ET The development of the international standards arising from the International Conference on Harmonization (ICH) are close to finalization and implementation. Hear about the status of the two related projects from an EMA and FDA perspective and the industry response to this work. Characterizing Drug Shortages and Their Causes: Anticipating Future Trends 2:30-4:00PM ET This session includes information on a 2012 study highlighting where and why drug shortages occur, as well as the impact of other forecasted drug development and commercialization trends. Tuesday, June 25 Aligning Statistical Science and Regulatory Practices for Expedited Safety Reporting 8:00-9:30AM ET Recommendations are presented from projects of the CTTI exploring expedited safety reporting for clinical trials, and aligning regulatory practices for reporting with statistics and patient expectations. Social Media, Mobile Applications and Patient Support Programs: Challenges and Solutions for Handling Drug Safety Information 8:00-9:30AM ET Discuss pharmacovigilance implications including adverse event handling and risk mitigation solutions from the regulatory and drug safety point of view. Big Data: Impact on Innovation 10:15-11:45AM ET Examine pharma, safety, and patient perspectives on big data and the need for real-world examples. EU Update: PROTECT and EnCePP 10:15-11:45AM ET Learn about PROTECT, which aims to develop and validate innovative methods for Benefit-risk assessment of medicine Periodic Reporting in Drug Safety: From Safety Updates to Continuous Signal Monitoring and Benefit-Risk Evaluations 1:45-3:15PM ET The session will present the new structure of PSURs/PBRERs according to the GVP/ICH E2C(R2) guidance. Requirements and challenges will be outlined. Quality Assurance for Signal Detection Programs 1:45-3:15PM ET New EU legislation requires quality assurance of critical safety processes, including signal detection. This forum will discuss the best practices for a signal detection program. Risk Management in the US, EU and Japan: The Challenges of Diversity 4:00-5:30PM ET This interactive forum will discuss the differences in legislation and the challenges of risk management planning in the United States, Europe, and Japan. Wednesday, June 26 Molecular Predictors of Drug-induced Harm: From Clinical Development to Postmarketing Surveillance 8:00-9:30AM ET This session will describe opportunities to identify molecular predictors of drug-induced harm in clinical development and postmarketing surveillance. Pharmacovigilance Update for Japan, Developing Asia and Latin America 8:00-9:30AM ET Review the current status of pharmacovigilance and provide suggestions on how to meet reporting requirements and working with licensing partners and affiliated companies in Japan and the developing world in Asia and Latin America. An Interactive Course on Likelihood Ratio Test-based Method for Signal Detection 1:45-3:15PM ET This workshop will provide an overview of the likelihood ratio test-based signal detection method for FDA’s AERS database, as well as a demonstration of the (LRT) tool. TransCelerate’s Collaborative Approach to Risk-based Monitoring: The Methodology 1:45-3:15PM ET Learn about the methodology developed by TransCelerate members for quality risk management and risk-based monitoring implementation. Herbal-induced Organ Toxicity (HILI): How That May Impact Rx Benefit-risk 4:00-5:30PM ET Discuss the role of natural health products in risk assessment and the importance of the internal review process. Developing a Patient Aid to Make Information about Treatment Benefits, Harms and Uncertainties Meaningful to Individual Patients and Enhance Their Decisions 4:00-5:30PM ET The session will: 1) raise awareness across the decision-making health community about recent drug regulatory science innovations driving a patient-focused approach; and 2) be a springboard to trigger further engineering of applications for these trends for use across the community. Thursday, June 27 Tracking Misuse and Abuse of Marketed Products: Is Pharma Doing All that It Can? 9:00-10:30AM ET This session will focus on the best practices involved in monitoring, tracking and reporting off-label use and misuse and abuse of pharmaceutical products. Coding with Confidence 9:00-10:30AM ET You will apply the key principles of the “MedDRA® Term Selection: Points to Consider” document by engaging in practical coding exercises in an interactive format. Off-target Blood Pressure Changes and Evaluation in Drug Development: Safety,Clinical and Regulatory Considerations 10:45-12:45AM ET Gain insight into the “off-target” BP response of drugs outside of cardiovascular drugs from a development and regulatory perspective. Sunday, June 23 Preconference Tutorials Kick off the week by extending your education prior to the start of the Annual Meeting. Register for two half-day tutorials or one full-day tutorial and SAVE $100 on of your Annual Meeting registration. Risk Communications 9:00AM-5:00PM ET Analysis of Safety Data from Clinical Trials 1:00-4:30PM ET Highlights of the New Pharmacovigilance Legislation in the EU: Key Points to be Taken into Account for Successful Implementation and Lessons Learned 1:00-4:30PM ET Keynote Speaker Hotel & Travel Exhibiting Daniel Kraft, MD Executive Director, FutureMed Book within the DIA Room Block, get special perks! 90% of the hall is SOLD. Reserve your booth today!

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Advancing Therapeutic Innovation and Regulatory Science - DIA2013 Preliminary Program available

Preliminary Program Now Available Online With our continued efforts to , DIA decided for the first-time to go digital with the Preliminary Program! Everything you need to know about DIA 2013 49th Annual Meeting can be found in the digital version: • Schedule At-A-Glance • Monday-Thursday Highlights • Global Regulatory Presence • Networking Opportunities • Quick Guide to this Year's Program • Getting to Boston, Hotel, and Travel • 450+ Exhibiting Companies • 250+ Sessions TransCelerate's Collaborative Approach to Risk-based Monitoring: The Methodology Wednesday, June 26 | 1:45-3:15PM Keynote Speaker: Daniel Kraft, MD, Executive Director, FutureMed Monday, June 24 | 8:30AM Start Planning Your DIA 2013 49th Annual Meeting Experience Today! View Preliminary Program Overview | Preliminary Program | Register Today

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DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Sciences - Boston, June 23-27

About DIA 2013 DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Sciences is the largest multidisciplinary event that brings together a global network of professionals to foster innovation that will lead to the development of safe and effective medical products and therapies to patients.

DIA 2013 49th Annual Meeting will:

• Provide a global unbiased platform to raise the level of discussion to facilitate innovation that will change the future of health care
• Provide comprehensive coverage of the full development and life cycle management process for all health care products
• Offer a holistic and integrated approach to the development and life cycle management of regulated health care products

To that end, DIA 2013 49th Annual Meeting provides the best opportunity to meet with people from around the world, share your views and knowledge, network, and build new relationships.

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“A lot is being done to try to advance clinical development to become more efficient, to become more effective, and that the DIA provides an opportunity to share those kinds of ideas.” - Jeffrey McMullen, President and CEO, PharmaNet/i3

“Well, DIA really prides itself on providing a neutral forum. And that aspect of neutrality not only means that our attendees can have more confidence in the content, but it also means we have a lot more diversity of stakeholders presenting.” - Craig Lipset, DIA 2012 Program Chair

“It’s definitely one of the leading meetings that we attend.” - Josef von Rickenbach, Chairman and CEO, PAREXEL International

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DIA’s Annual Meeting brings together all the stakeholders to enhance the health and well-being of patients.

Deadline for Application Feb 1 - Patient Advocate Fellowship Program

 

Special Opportunities for Patient Representatives Patient Advocate Fellowship Program: Do you represent a 501(c)(3) organization in the United States or registered charities in Canada that serve constituents with: • Major chronic diseases; and/or • Rare/ Orphan diseases? Then you can’t afford to miss your opportunity to apply for a scholarship to attend the DIA 2013 49th Annual Meeting as part of the Patient Advocate Fellowship Program. 20 patient representatives, chosen through a competitive process, will have opportunities to develop, strengthen, and support collaborations with policymakers, industry, academia, and health professionals by taking part in all facets of DIA 2013 49th Annual Meeting. Deadline for Applications: Friday, February 1, 2013 What is the Patient Advocate Fellowship Program?  The DIA Patient Advocate Fellowship Program is designed to: • Develop, strengthen, and support patient collaborations with policy makers, health professionals, industry representatives, and academia • Increase the knowledge and understanding of patient groups about key issues central to patient-centered health care, biomedical research, and drug development • Develop the capacity of patient groups to advocate for change • Improve alliances between patient groups and other health care stakeholders • Stimulate cooperation, promote dialogue, and share best practices DIA 2012 48th Annual Meeting Participating Organizations: ARPKD/CHF Alliance,  Averys Angels Gastroschisis Foundation, Canadian Organization for Rare Disorders, Cholangiocarcinoma Foundation, HepTREC, Huntington's Disease Society of America, International Cancer Advocacy Network, International WAGR Syndrome Association, Lupus Foundation of America, Mass General Cancer Center, Mastocytosis Society, MRSA Survivors Network, National Alliance for Medication Assisted Recovery, National Dysautonomia Research Foundation, Nueva Vida (Latin Women with Cancer), Ovarian Cancer National Alliance, Soft Bones, Sturge-Weber Foundation, United Nations Bone and Joint Decade, Vestibular Disorders Association   What is the DIA 2013 49th Annual Meeting? DIA 2013 49th Annual Meeting connects all partners involved in bringing new therapies to patients. Historically, this enterprise has focused on drug development, but today those partners include a very diverse range of stakeholders from biotechnology, diagnostics, and medical device companies, to regulatory agencies, scientific and academic communities, service payers and providers, and patient organizations. See for Yourself... Global Patient Initiatives Patient organizations are key players in DIA’s mission to foster innovation to improve health and well-being worldwide. Find out how you can make an impact as a patient group representative. Questions About the Application or Eligibility? Contact Donna Mayer at Donna.Mayer@diahome.org. Special Discount for Patient Organizations: DIA offers another opportunity for patient organizations at the Annual Meeting by offering registration for only $250, which includes a one-year complimentary e-membership. Proof of 501 c3 status required. Download the registration form. Just Released! Keynote Speaker: Daniel Kraft, MD Executive Director, FutureMed Hear from Dr. Kraft regarding the DIA 2013 49th Annual Meeting

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Keynote Speaker Announced for the DIA 2013 49th Annual Meeting: FutureMed's Dr. Daniel Kraft

Keynote Speaker Announced for the DIA 2013 49th Annual Meeting Keynote Speaker:  Daniel Kraft, MD Executive Director FutureMed DIA is pleased to announce Dr. Daniel Kraft as the Keynote Speaker for the DIA 2013 49th Annual Meeting. Dr. Kraft will speak on Monday, June 24 during the Opening Plenary scheduled for 8:30 AM ET. Daniel Kraft, MD is a Stanford and Harvard trained physician-scientist, inventor, entrepreneur, and innovator with over 20 years of experience in clinical practice, biomedical research, and health care innovation. Dr. Kraft chairs the Medicine track for Singularity University and is Executive Director for FutureMed, a program which explores convergent, exponentially developing technologies and their potential in biomedicine and health care. Dr. Kraft’s Accomplishments:      • Founded IntelliMedicine, focused on enabling connected, data driven, and integrated        personalized medicine      • Invented the MarrowMiner, an FDA approved device for the minimally invasive harvest of        bone marrow      • Founded RegenMed Systems, a company developing technologies to enable adult stem        cell based regenerative therapies   Register by January 31 to Save! Registration and Housing is Now Open Only registered attendees have access to hotels within the closest proximity of the BCEC, and the DIA Courtesy Shuttle will only be available to attendees staying at DIA room block hotels. Register and book your room today! Register Online | Book Your Hotel Important DIA 2013 49th Annual Meeting Deadlines Fast Approaching      • Call for Professional Posters Deadline: Thursday, February 28, 2013      • Call for Student Posters Deadline: Monday, March 11, 2013      • Patient Advocate Fellowship Program Deadline for Applications: Friday, February 1, 2013 Start Your Week Off Right! Extend Your Education Prior to the DIA 2013 49th Annual Meeting Register for two half-day tutorials or one full-day tutorial and receive $100 off of your Annual Meeting registration. View Tutorials and Reserve Your Seat Today!