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Wednesday, May 07, 2008 |
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DIA Annual Convention:
Join more than 8,000 attendees as they share information about the latest innovations in drug development and search for solutions to industry challenges.
Highlights of this year's event:
• Over 360 sessions across 26 content areas
• 40 preconference tutorials
• Over 1000 speakers, including representatives from FDA, EMEA, and other global regulatory agencies
• 500+ exhibiting companies
• Networking Reception at the Boston Museum of Science
Please click here for more information. |
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Drug Approval Trends at the FDA and EMEA
Process improvements, heightened scrutiny and industry response
• Delayed approvals. Regulators are requesting more data to validate or refute conclusions about product risks. This is creating a rise in the size and number of clinical trials as well as overall research budgets.
• Rising R&D costs. Drug developers are continually increasing their R&D expenditures to generate approvable drug applications, despite rising financial pressures in the industry. Emerging technologies such as stem cells, genomics and proteomics are among the most prevalent initiatives being used to identify appropriate drug candidates.
• US generics focus. The FDA is allocating resources to generic drug approvals in an attempt to speed these products to market. However, although Europe has recently developed a clear regulatory path for generic versions of biologicals, this is yet be achieved in the US.
• Regulatory process improvements. Regulators are enhancing their drug review processes with new technologies such as electronic drug applications and technology-based standards for drug review.
Click Here for More Information |
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• BioTechxus (Fort Worth, Texas) Hot Job of the Day:
Alcon Laboratories
Clinical Team Leader
Implement clinical pharmacology studies and project-related activities to support the clinical evaluation of Alcon lead candidates. Provide strong leadership to subordinates and facilitate and support their roles within the CP Unit.
• Biotech Beach (Irvine, California) Hot Job of the Day:
ClinAssure, Inc.
Senior Clinical Research Associate ( Senior CRA )
As a member of the clinical team under supervision, this position is responsible for performing clinical research activities related to all clinical research studies and projects according to Federal Regulations and ICH guidelines.
• Genetown (Cambridge, Massachusetts) Hot Job of the Day:
Clinical Brokers
Clinical Project Manager
The Study Manager manages and leads a cross-functional Study Team for the entire duration of the study.
The overall objective of the Study Manager is to manage the planning, implementation, analysis and reporting of assigned less complex global and local studies within the established timeframes and budget, with the quality and requirements necessary for global regulatory approvals.
• Pharm Country (Parsippany, New Jersey) Hot Job of the Day:
Daiichi-Sankyo
Study Manager, Clinical Pharmacology
The incumbent will be responsible for the implementation and day-to-day coordination of TMCP studies conducted in North America and Europe. Drug candidates under investigation may belong to any therapeutic area.
• Biotech Bay (Berkeley, California) Hot Job of the Day:
University of California, Berkeley (CAL)
Teaching Lab Research Associate III
The Teaching Lab Research Associate will work in the Instructional Lab Support Unit and is responsible for the organization and preparation of the undergraduate Immunology Laboratory course (MCB 150L).
Get Noticed! Add your resume to the BioSpace Career Center!
See more than 5,000 job postings in the BioSpace Career Center! |
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BioSpace.com is pleased to present the Boehringer Ingelheim Career Fair on Thursday, May 8th at The Sheraton Boston Hotel in Boston, Massachusetts from 11:00 a.m. to 4:00 p.m. You must pre-register in order to attend this event.
For this event, Boehringer Ingelheim is ONLY interviewing candidates with the following backgrounds:
• Immunology/Inflammatory Disease Research - Scientists with BS, MS, and/or PhD
• Medicinal Chemistry - Scientists and Principal Scientists with MS or PhD
• Cardiovascular Disease Research - Scientists and Principal Scientists with MS or PhD
• Translational Sciences - Director level with PhD experience in Systems Biology and/or Electronic Biology
• Biologics/Biomolecular Sciences - Scientists and Principal Scientists with BS, MS, or Ph.D. and experience in Antibody/protein engineering
• Animal Resources - Facility Managers with BS and GLP experience
• Clinical Trial Support - Scientists with BS or MS degree in related field
We look forward to seeing you at the Boehringer Ingelheim Career Fair!
• Boehringer Ingelheim Career Fair, May 8, 2008
• Pharm Country Career Fair, June 5, 2008
• DDT - BioSpace 2008 Career Fair, August 6, 2008
• DeviceSpace Career Fair, September 8, 2008
• BioCapital Career Fair, September 30, 2008
• Biotech Bay Career Fair, October 14, 2008
More information about BioSpace's Career Fairs |
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Drug Development Clearly Explained
• Clear text explaining all aspects of global development, from laboratory to market hyperlinked to relevant guidelines
• Suitable for scientists, developers, business people wanting a clear but comprehensive summary.
• 21 Chapters, with key points and questions/answers to insure understanding
• E-book/pdf format/secure download only
250 pages plus 1800 page appendix. $295/EUR190; corporate licences for multiple users available.
www.alladex.com |
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Hot Company
Vertex Pharmaceuticals Incorporated
11010 Torreyana Road
San Diego, California 92121 U.S.A.
Phone: 858-404-6600 Fax: 858-404-6726
View Jobs
Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company’s strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex’s product pipeline is focused on viral diseases, inflammation, autoimmune diseases, cancer, pain, cystic fibrosis and bacterial infection. Vertex co-discovered the HIV protease inhibitor, Lexiva, with GlaxoSmithKline. |
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ClinicaSpace NewsBeat Team
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Editorial & Production Staff:
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Lana Ho
ClinicaSpace.com - The Most Trusted Source for Daily Clinical News |
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• Please distribute this e-cast freely.
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Copyright 2008 ClinicaSpace http://www.clinicaspace.com
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