Essentials for Success! – Join DIA China Medical Affairs and Medical Writing Training Now

Essentials for Success! – Join DIA China Medical Affairs and Medical Writing Training Now December 9-10, 2013 | Shanghai, China With the changes in local and global environments and requirements for compliance in the healthcare, more challenges are expected for the professionals working in the medical affairs and medical communication communities. The course, which is designed based on adult learning principles, evidence and rich experience, will provide highly interactive opportunities for participants to learn. The course will benefit professionals by providing knowledge, experience, and tools to better navigate ways through the challenges associated with communication and trusted relationships development with external and internal customers. Who Should Attend Medical Affairs Medical/Scientific Writing Clinical Research & Development Medical Communications/Information Professional Development Download the Program   Program Chairperson   Main Instructors   Min IRWIN, MD, PhD Vice President, Medicines Development, GlaxoSmithKline, China   Karen WOOLLEY, PhD CEO, ProScribe Medical Communications, China, Japan & Australia Professor, University of Queensland and University of the Sunshine Coast, Australia Julie MONK, PhD Medical Writer, ProScribe Medical Communications, China, Japan & Australia Upcoming Event DIA China Member Online Management Dear Member DIA China Member Management is now online. You can log in DIA China website at www.diachina.org to view and manage your data for receiving the latest international pharmaceutical information.

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DIA's 8th Annual Conference - The New Clinical Research Environment in India

Join Prominent Professionals to Discuss the Changing Industry Join academia, industry, regulators and researchers to discuss the new environment for health care product development at DIA India’s 8th Annual Conference. The event, to be held in Bangalore from October 24 to 26, will provide a forum for professionals to hear how their peers are coping with the challenges of new regulations and how they are planning to realize the promise of emerging opportunities. More than 90 renowned experts will speak on key issues, including keynote presenters Prof. Ranjit Roychaudhuory, Chairman of the Task Force for Research at Appollo Hospitals Group, and Mukhtar Ahmed, Oracle HSGBU’s Vice President of Product Strategy. The conference will also feature 12 tracks with 48 sessions on the key themes of clinical research, IT, life sciences, medical writing, and biostatistics. Program highlights include: Direction, outlook and vision for health related research in India Review of recent changes in regulations and their implications Challenges to global development and commercialization ex-India New opportunities for India-centric global delivery solutions Global benchmarks in health care research regulations Patient-centric endeavors for awareness and ethics of research Exhibiting and Support Opportunities are available! Click here for more information. Overview View Program Register Now upcoming events THANK YOU TO OUR MEDIA PARTNERS Keynote Speakers Padmashree Ranjit Roy Chaudhury Apollo Hospitals Group Mukhtar Ahmed Oracle HSGBU Featured Topics Drug Discovery Development Manufacturing Commercialization Regulatory Ethical, Social, Legal, Technology & Standards Lean Strategy Outsourcing Strategy Pharmacovigilance Therapeutics Overview View Program Register Now

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What's the best design processes to guide you through the progression of research and development?

Fourteen Steps from Research to Development
June 23 from 1:00PM – 4:30PM in Boston

This tutorial will include discussion of each of the 14 steps used to develop the optimal strategic plan will address the resources and various approaches to tailoring the plan to a sponsor’s specific product under development and obtaining FDA concurrence with the strategic plan. A smooth progression through the preclinical process into early clinical programs will be presented in this half day tutorial targeted to familiarize pivotal staff in startup companies with the required terminology and functions, pharmaceutical/biological companies that have yet to file INDs and those who want to improve their early development approach.

Instructor:
Michael R. Hamrell, PhD,RAC
President
MORIAH Consultants, United States

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.

Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.

What do you need to know about statistics? Variability~confidence intervals~hypothesis testing~p-values?

Clinical Statistics for Nonstatisticians
June 23 from 9:00AM – 5:00PM in Boston

This tutorial will introduce basic statistical concepts that are fundamental to clinical research. It is designed for individuals with some exposure to statistics (either through course work or on-the-job experience) that is equivalent to an introductory statistics course. While a few formulae are included for individuals who are interested in computational details, the overall emphasis of the tutorial will be on the application of statistical concepts to clinical investigation.

Instructor:
Michael C. Mosier, PhD
Director, Biostatistics
EMB Statistical Solutions, LLC., United States

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.

Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.

What are the ethical considerations in conducting clinical research?

Overview of Drug Development
June 23 from 9:00AM – 5:00PM in Boston

This tutorial will provide an introduction to the drug development process under FDA and ICH Guidelines, including how various parts of companies fit into the overall process of pharmaceutical development.

Instructor:
George H. D'Addamio, PhD
President
PharmConsult Inc., United States

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.

Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.

Nonclinical and Translational /Early Phase Clinical Development Track at DIA's 49th Annual Meeting

 

	How can we optimize the transition from Preclinical to Clinical Research?
	How can we design a strategy for efficient, rapid and inexpensive assessment of drug-related QT effects?
	What is the Impact of Subject Dual Enrollment on Study Data Validity?
	What are the opportunities for drug-induced vacsulitis biomarkers and translational medicine research areas.
	What are the benefits of PET imaging in preclinical and clinical therapeutic drug development?
	What is the impact of Pharmacometrics in Preclinical to Early Phase Clinical Development?
	When are human abuse liability studies indicated by FDA?
	What is the impact of regional cooperation on drug development innovation in China and Latin America?

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? 

Share Your Expertise with a Global Audience - CALL FOR ABSTRACTS

Share Your Expertise with a Global Audience Submit an abstract for one of DIA’s events around the world to help advance health care and exchange knowledge with industry colleagues. 7th Annual Clinical Forum October 8-9 | Dublin, Ireland Deadline: April 4 14th Conference on European Electronic Document Management (eDM) November 20-22 | Dublin, Ireland Deadline: April 18 26th Annual EuroMeeting 2014 March 25-27, 2014 | Vienna, Austria Deadline: May 29 DIA's Annual Canadian Meeting: New Reality/New Frontiers October 29-30 | Ottawa, ON, Canada Deadline: April 16 This Annual Meeting brings together Canada’s key thought leaders to discuss how to embrace the changes to drug development and regulatory requirements, as well as patient safety and greater access to efficacious drugs. Abstracts can be submitted for a topic for following three tracks: New Frontiers, Communications and/or New Realities. DIA/NORD US Conference on Rare Diseases and Orphan Products October 7-9 | North Bethesda, MD, United StatesAbstract submission opening soon!The US Conference on Rare Diseases & Orphan Products is the 3rd annual program representing collaboration among academic researchers, clinical researchers, pharmaceutical and biotechnology companies, regulatory and health agencies, patient organizations, payors and venture capital/private equity to address the need for effective therapies for rare diseases. EDM and ERS/eCTD: Impact of e-Initiatives October 2013 | San Diego, CA Abstract submission opening soon! By focusing on the entire content continuum from authoring to submission delivery and maintenance, we’ll look at approaches, impacts and challenges in implementing the necessary standards to ensure regulatory compliance. For more information about abstract submission click here.

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