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Friday, May 09, 2008 |
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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.
• Pharm Country (Montville, New Jersey) Hot Job of the Day:
Bayer HealthCare Pharmaceuticals
Clinical Safety Associate/Senior Clinical Safety Associate
The incumbent will be responsible for prioritizing all U.S. serious and non-serious adverse events received from physicians, investigators, pharmacists, nurses, consumers, patients, CROs (Clinical Research Organizations), and sales representatives.
• Biotech Bay (South San Francisco, California) Hot Job of the Day:
Breightworth Recruiters
Associate Director Clinical Operations
Manages resources, timelines and budgets for clinical programs run globally and within the United States to meet clinical and corporate goals and metrics.
• 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.
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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New BioSpace White Paper!
Biotech Career Fairs For Job Seekers 101: Control Your Experience
By June Salvati, BioSpace Director of Events and Corporate Services
Read it Now!
We are pleased to present the BioSpace Career Fair in Pharm Country on Thursday, June 5, 2008 at the Hanover Marriott in Whippany, NJ.
BioSpace Career Fairs give job seekers the opportunity to meet face-to-face with the region's elite science industry employers while presenting the opportunity to interview for hundreds of specialized open positions.
CLICK Here to submit your resume for the Pharm Country Career Fair now!
Qualified candidates will receive their invitations and confirmation numbers via email 24 to 48 hours after their resumes have been submitted. Pre-screened and accepted candidates must bring a copy of their invitation with confirmation number to the event.
We look forward to seeing you at the Pharm Country Career Fair!
• 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
Resolvyx Pharmaceuticals, Inc.
6A Preston Court
Bedford, Massachusetts 01730 U.S.A.
Phone: 781-541-5045 Fax: 781-541-5046
View Jobs
Resolvyx is a biopharmaceutical company committed to the discovery and development of therapies based on the novel concept of inflammation resolution through activation of the body's own off-switch mechanisms. With their endogenous origin we believe the breakthrough concept of resolvins will provide a unique risk/benefit offering for the treatment of chronic inflammatory conditions. |
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Send questions and comments to the
ClinicaSpace NewsBeat Team
East Coast Office:
ClinicaSpace
Ramshorn Executive Centre
2399 Highway 34, Building A-5
Manasquan, New Jersey 08736-1528 U.S.A.
Phone: 732-528-3688
Fax: 732-528-3668
West Coast Office:
ClinicaSpace
90 New Montgomery Street, Suite 414
San Francisco, California 94105 U.S.A.
Phone: 877-277-7585
Fax: 415-576-9217
Editor & Publisher:
Editorial & Production Staff:
Annalyn Aquino
Suvarna Bhatt
Lana Ho
ClinicaSpace.com - The Most Trusted Source for Daily Clinical News |
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• ClinicaSpace is a registered trademark of BioSpace, Inc.
• Please distribute this e-cast freely.
• Credit any excerpts as follows:
Copyright 2008 ClinicaSpace http://www.clinicaspace.com
• While BioSpace and its agents used their best efforts in collecting and preparing
the information published herein, we do not assume, and hereby disclaim, any liability
for any loss or damage caused by errors or omissions, whether such errors or omissions
resulted from negligence, accident or other causes.
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