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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DIA's Annual Canadian Meeting: New Reality/New Frontiers

DIA's Annual Canadian Meeting: New Reality/New Frontiers DIA Members Save $150. Early-bird expires October 7. Collaborate with key stakeholders: boost awareness and deliver value to today’s patient reality driving change in drug development and regulations. At this Annual Meeting, stakeholders from industry, regulatory agencies, academic researchers, patient and patient advocacy groups will have the opportunity to work together to recognize the challenges faced by the industry and regulators in drug development, market access, and regulations in Canada.  Opening Remarks: Kathryn McDade Assistant Deputy Minister of the Health Products and Food Branch Health Canada Plenary Sessions:     • International Regulatory Cooperation            - Trends and Impacts            - Stakeholder Perspective Break Out Sessions:     • Harmonizing in the Post-Approval Pharmacovigilance:       Challenges and Opportunities     • Social Media     • Update on ICH: What You Need to Know     • Research Networks and Translational Medicine     • Support Programs: The Pursuit of Patient Advocacy     • Update on the Legislative and Regulatory Modernization Initiative     • IT Modernization     • Plain Language Labeling in the Regulatory System: Consumer- and       Patient- Centered Information     • Publicly Accessible Registries: What Clinical Trial Information Needs       to be Disclosed?     • Cool Tools in Medical Devices     • Plus More Tutorial Topics:     • The Emerging PV Landscape in Canada     • Trends in Health Canada Inspections Register 3, Get the 4th FREE! Register three individuals from the same company and receive complimentary registration for a fourth! All four individuals must register and prepay at the same time. Table Top Exhibits: Showcase your products and services to key decision makers in Canada. View Application Now.   View Agenda | Overview | Register Now

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Your Tailored Agenda Covering Rare/Orphan Diseases for DIA 2013 49th Annual Meeting

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 professionals involved with Rare/Orphan Diseases. We did the work for you! What’s more, bring your colleagues or your whole team - divide and conquer - with so many exceptional sessions, split 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.   Monday, June 24 European Town Hall: Implementation of New Safety Legislation and Other Hot Topics 11:00AM-12:30PM ET The focus of this forum will be on the first experiences with the new PRAC and how the PRAC interacts with the different EU committees (such as the CHMP and CMDh). Roundtable on Personalized Therapy Innovation in Rare Disease: Focus on Public Policy 2:30-4:00PM ET Orphan product developers face unique challenges that multiply when combined with the need for co-registered diagnostic devices. This forum will discuss the latest policy trends impacting personalized orphan products and patient access. Tuesday, June 25 Research Advances for Rare Diseases and Orphan Products 8:00-9:30AM ET In 2012, a third of the drugs approved by the FDA had orphan designation. This session will examine the current research efforts and discuss the role of the patient community, the FDA, the NIH and the drug industry in research priorities and challenges. Is There a Recipe for Successful Implementation of Registries for Rare Diseases? 1:45-3:15PM ET This session will describe how registries can support development of new drug for rare diseases, how they can contribute to regulatory approval, and decisions on access to orphan medicinal products. Roundtable on Personalized Therapy Innovation in Rare Disease: Focus on Public Policy 2:30-4:00PM ET Orphan product developers face unique challenges that multiply when combined with the need for co-registered diagnostic devices. This forum will discuss the latest policy trends impacting personalized orphan products and patient access. Development for Rare Disease Treatments 4:00-5:30PM ET This symposium will review various aspects of therapy development for rare and orphan diseases. The difficulties and trade-offs in developing a comprehensive patient registry to assess natural disease progression and treatment effects will be highlighted using pemphigoid as a case example. Wednesday, June 26 Models for Genomic Research Success: How a Patient-Researcher Relationship Led to the Discovery of a Norepinephrine Transporter Deficiency and the Emerging Role of Crowd Sourcing in Rare Disease Research 8:00-9:30AM ET Get a review of successful genomic studies that have been driven by strong patient-investigator relationships, and the recent role of social media and crowd sourcing in rare disease studies. Using Legislation to Advance Regulatory Science: "I'm Just a Bill..." 8:00-9:30AM ET Several legislations have been introduced for regulatory reform of the drug approval process. This session will discuss impacts on the pharmaceutical industry, investment community, and patient community. Rising to the Challenge of Developing Novel Orphan Medicines for the Global Market 1:45-3:15PM ET One in ten people could be affected by a rare disease; for many there is no treatment, yet modern technology could resolve this. This session investigates the opportunities available to facilitate successful global development of novel orphan medicines. Rescuing and Repurposing Drugs: Challenges and Opportunities 4:00-5:30PM ET Drug rescue and repurposing presents an opportunity to spur the drug development process by building upon previous research and development efforts. However, this strategy also has challenges, particularly related to treatments for rare and orphan diseases. Thursday, June 27 The Not So Rare Challenge that Faces Rare Disease Development: Demonstrate Value 9:00-10:30AM ET Increased development of orphan products has changed how payer regulators view rare diseases. Rare disorders can now have several products FDA indicated for use; this requires that developers demonstrate the value of these rare disease products. Orphan Drug Development Strategy by Big and Medium/Small Pharmaceutical Industries 9:00-10:30AM ET This session will address considerations for planning the development and commercialization strategy of orphan drugs by large as well as small companies. 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. View Preconference Tutorials ‘Class of 2013’ Patient Advocate Fellowship Program      • African-American Community Health Group        of the Central Coast      • AIM at Melanoma      • American Cancer Society Cancer Action        Network      • Angioma Alliance      • Ann's Place: the Home of I CAN      • Coalition for Pulmonary Fibrosis      • Dystonia Medical Research Foundation      • Hepatitis Education Project      • Hermansky-Pudlak Syndrome Network      • Leukemia & Lymphoma Society - Mass Chapter • Lymphatic Research Foundation • MitoAction • National Foundation for Celiac Awareness • NephCure Foundation • PMP Pals • Program in Personalized Medicine & Targeted   Therapeutics • Recurrent Respiratory Papillomatosis    Foundation • Spinal Muscular Atrophy Foundation • The Michael J Fox Foundation for Parkinson's     Research 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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Speak at the Clinical Forum 2013 - Submit an Abstract – Deadline Thursday, 4 April 2013

Event Title: 7th Annual Clinical Forum       

Meeting Date:
10/8/2013 9:00:00 AM - 10/9/2013 5:30:00 PM

Location:
The Convention Centre Dublin, CCD Spencer Dock North Wall Quay Dublin 1 Ireland       

Overview:
The DIA Clinical Forum is widely recognised as the only European conference that brings together industry thought leaders across the key disciplines of data management, clinical operations, drug safety and medical communications. This affords delegates the opportunity to network with professional colleagues from all disciplines and from more than 20 countries. You will meet professionals from the pharmaceutical and biotech industries, professionals from academia, CROs, clinical trial sites, health regulatory agencies and delegates from patient organisations.

Target Audience:

Professionals at all levels in the following disciplines:

• Clinical data management
• eClinical
• Clinical research
• Clinical operations
• Post-marketing development
• Clinical safety and pharmacovigilance
• Personal development
• Validation
• Quality assurance
• Medical information and communications
• Medical writing
• Patient advocacy

Special Opportunities for Patient Representatives - Deadline for application is Feb. 1

Special Opportunities for Patient Representatives Dear Colleague, 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. Through the Patient Advocate Fellowship Program, DIA is working to ensure that the "voice of the patient" is heard globally in every facet of the life cycle management of pharmaceuticals, medical devices, and related health care products. Twenty 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 in Boston. Deadline for Applications: Friday, February 1 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 Hear more about DIA's Patient Advocate Fellowship Pogram: 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 What Others Say about the DIA Annual Meeting... Global Patient Initiatives Patient organizations are key stakeholders 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 (c)(3) status required. Download the registration form. Keynote Speaker: Daniel Kraft, MD Executive Director, FutureMed Hear from Dr. Kraft regarding the DIA 2013 49th Annual Meeting

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