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Thursday, November 05, 2009 |
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Discuss Current Developments in eCTD in the US and Europe, Filing CTD formatted Submissions in Other Markets, and Emerging Technologies Affecting Electronic Submissions.
• Discuss emerging and future trends in electronic submissions including Regulated Product Submission (RPS);
• Identify challenges and benefits of transitioning to eCTD;
• Identify the various methods of submitting electronic submissions to global health authorities;
• Create guidance-compliant INDs, NDAs, MAAs, NDSs, DMFs, and ANDAs in eCTD format to ensure acceptance and reviewability;
• Differentiate between "guidance" and "regulation" and their impact on the process;
• Recognize the vital role of good document management and best business practices in the overall process of preparing the eCTD; and
• Describe the role of eCTD standards and their impact to the development/delivery process.
Click Here to Learn More |
More Top News |
LEARN BIOSCIENCE BUSINESS DEVELOPMENT IN THE HEART OF SILICON VALLEY
Bioscience Business Development: Building Value
UCSC Extension in Silicon Valley
December 3-4, 2009
Santa Clara, California
Gain insight into the critical roles that business development and licensing play in the commercialization of a new product and the development of a successful bioscience company. Through lectures and case studies, the expert instructional team addresses the importance of well-executed opportunity assessments, the hallmarks of viable business models and strategies, and the key financial vehicles for funding and maintaining companies.
With courses spanning discovery, clinical, regulatory and market, UCSC Extension in Silicon Valley helps busy professionals gain the practical knowledge they need to excel in this dynamic industry.
Visit www.ucsc-extension.edu/biosciences to learn about all of our bioscience programs. Questions? E-mail biosciences@ucsc-extension.edu or call 408-861-3860.
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More Featured News |
Neuroscience & Spine Centers of Excellence Summit
January 27th-29th
Barrow Neurological Institute: Phoenix, AZ
With an estimated one in three Americans suffering at some point from a neurological disorder, and an increasing number of aging population with an increased awareness of neurological diseases/treatments, the Neurosciences is becoming one of the most important clinical areas for hospitals and health systems to manage. Due to the recent advances in technology, declining payor reimbursements, and increasing number of baby-boomers, most hospitals, physicians and healthcare facilities are starting to see the benefits of defining themselves by centers of excellence and are willing to invest in comprehensive neuroscience programs. It is imperative for you to develop the planning and investment strategy to succeed in this highly competitive field and capture the
For more information, please visit: http://www.acius.net/wiki.aspx/Conferences/Upcoming?view=overview&id=143 |
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The CRO Market Outlook: Emerging Markets, Leading Players and Future Trends
• Identifies and analyses the most recent trends and issues in outsourcing clinical R&D.
• Describes where clinical trials will be conducted in the future.
• Explores the complexities and the costs of outsourcing R&D to different world regions.
• Profiles the major international CRO players.
• Provides a detailed assessment of the current CRO market, including market share information and the size/growth of R&D spending.
Click Here for More Information |
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• Biotech Beach (Santa Barbara, California)
Johnson & Johnson Pharmaceutical Research & Development, LLC
Associate Director, Regulatory Affairs
The primary responsibility of the Associate Director, Regulatory Affairs is to serve as Regulatory lead for the Mentor Biologics group through delivery of CMC expertise, regulatory strategy, and detailed project planning for US and global regulatory submissions.
• Genetown (Home Base, Massachusetts)
PAREXEL International
Project Director
To deliver high quality, timely, and profitable projects. To provide overall project management of clinical trials or clinical programs.
• Pharm Country (New York, New York)
Autism Speaks
Psychometrician - Research
The selected individual must be experienced and able to perform duties that support the collection of phenotypic data for the Autism Genetic Resource Exchange (AGRE), a gene bank and data resource created in order to advance research in autism spectrum disorders.
• Biotech Bay (Sunnyvale, California)
Intuitive Surgical, Inc.
Medical Advisor
The Medical Advisor conducts early and pre-clinical scientific research and/or development. This position will investigate the feasibility of applying a wide variety of scientific principles and concepts to potential inventions, products and problems.
• BioCapital (Gaithersburg, Maryland)
The Vaccine Consortium
Senior Executive, Reimbursement/Eligibility Specialist
As a full time employee, you will provide expertise on reimbursement/eligibility and coding for payment for both pharmacy and medical benefits for injectables and pharmaceuticals.
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WEDDLE's Job Board Poll
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Plasma Protein Therapeutics Association
147 Old Solomons Island Road, Suite 100
Annapolis, Maryland 21401 U.S.A.
Phone: 202-789-3100 Fax: 410-263-2298
View Jobs
The Plasma Protein Therapeutics Association is the primary advocate for the world's leading source plasma collectors and producers of plasma-based and recombinant biological therapeutics.
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