The 4th Pharmacovigilance Conference in India is now only three days away.

Don’t Miss Your Chance to Exchange Knowledge The 4th Pharmacovigilance Conference in India is now only three days away. Take this opportunity to discuss the latest global challenges in drug safety with professionals worldwide. Professionals attending the two-day conference, to be held in Bangalore from March 8-9, will learn about current global safety reporting requirements for prescription and over-the-counter drugs and discuss new, pragmatic approaches to pharmacovigilance. Other key topics will include the regulatory agency clinical safety and pharmacovigilance inspection program in the US, Europe, and Japan, and identifying best practices for quality assurance in post-marketing pharmacovigilance and clinical safety. Read More View Program Register EXHIBITING OPPORTUNITY Download the application for a tabletop display at the event. Other events of Interest Download the India Calendar of Events Conference Highlights Updates on recently released GPvP Modules by EMA Japanese model of EPPV – a way forward for other Asian countries Challenges in authoring PSUR for generic manufacturers An insight into Drug Induced Liver Injury (DILI) Global regulatory compliance: challenges and the way forward Safety regulations in emerging Middle East region Efficient management of literature searching Enhanced productivity and quality through process re-engineering; case studies Global outsourcing trends in PV – Indian potential and challenges by China, Taiwan, and Latin America RSI management – best practices to safeguard against pitfalls Attrition and manpower stability; KPO perspective Technology-watch against safety hazard of spurious and adulterated drugs Training; A Formality or a Reality – an industry insight Panel discussion: compensation for trial related injuries This Pharmacovigilance Conference is perfect for professionals with experience in clinical safety and who are involved in: Pharmacovigilance Clinical research Risk management Compliance Medical information Regulatory affairs Academia Pharmacology Read More View Program Register To know more, contact Manoj.Trivedi@diaindia.org Thank You to our Media Partner

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Rare Disease, Orphan Conditions, Patient Advocacy sessions at Philly June DIA2012

DIA 2012 Collaborate to Innovate

48th Annual Meeting
June 24-28, 2012
Philadelphia, PA
Pennsylvania Convention Center

•Orphan Drug Development: Global Regulatory Challenges and Initiatives
This impactful session will focus on the critical need for developing orphan drugs, provide a review of global orphan drug development challenges, and offer information on various strategies designed to overcome these challenges.

•Challenges of Orphan Drugs in the US, EU, and Japan
This session addresses the current status and forthcoming activities related to orphan drugs in the US, EU, and Japan. Orphan drug development is obviously essential in these regions, and the provisions in place on drugs including rare diseases are often passed over. We will also address the unique market situation of orphan drugs in the US and development and commercialization strategies of orphan drugs in each region.

•Natural History Studies for Rare Diseases and Orphan Conditions
This session presents an overview of the design, conduct, and benefits of natural history studies of rare diseases and orphan conditions from varied perspectives of researchers, patients and a regulatory agency.

•Social Media 2.0: The Power of Online Rare Disease Communities to Connect and Engage ePatients
FORUM

•Drug Development Strategies for Integrating Academia, Non-governmental Organizations (NGOs), and Industry Based on Experience in Neglected and Infectious Diseases
This session will describe drug development strategies for integrating academia, non-governmental organizations (NGOs), and industry based on experience for the development of drugs for neglected and infectious diseases in the global health arena.

•Patient Advocacy in Medical Product Development: The Evolving Relationship Between FDA and Its Patient Stakeholders
This session will explore the role of patient advocates in FDA decision-making. FDA will describe its patient advocacy programs and the value they have added. A patient representative will discuss their interactions and experience with the agency.

•Rare Disease Clinical Research Consortia: Immediate and Rich Sources of Translational Research Data, Partnering Opportunities
Rare disease clinical research consortia offer a rich data source for translational research. Investigating diseases from porphyria to pediatric cholestasis, they present an array of collaborative opportunities for the pharmaceutical industry.

•Patient Advocacy and Your Next Generation of Research:  How Nonprofit Organizations Can Accelerate Product Development
This session provides insights into the rapidly emerging world of collaborations between pharma and patient advocacy organizations to accelerate basic and clinical research by leveraging the data and participation from patients.

•Understanding the Challenges of Conducting Studies for Orphan Indications and Rare Diseases
Conducting a research study for an orphan indication and/or rare disease involves unique considerations in addition to the more common challenges of clinical research. Key logistical and operational considerations will be discussed including sharing of specific, relevant examples from different therapeutic areas and clinical settings as well as strategies and techniques to navigate the challenges. The session will also address specific examples of materials, procedures and techniques developed and utilized for protocol/study design development, site identification and support, IRB/EC approval, subject recruitment and retention, subject support, and program timeline and budget management.
 
•Emerging Role of the Patient Voice on Drug Policy in Japan
Patients and lay people in Japan now form one of the major groups that support current drug development, safety, supply, and regulatory affairs. This session will discuss recent change and the significant effect of the patient voice on drug policy and the progress of the amendment of the Pharmaceutical Affairs Law.