Date:
Fri, September 14, 2007 09:22:13 PMFrom:
PharmCast Dot Com
Subject:
PharmCast.com's Official Newsletter, September 16, 2007
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P H A R M C A S T D O T C O M
The www.PharmCast.com Official
Newsletter
--------- September 16 - 07 ---------
+++ PharmCast.com's Executive MBA Program Highlight+++
The University of Colorado Executive MBA Program in Health
Administration offers an option in Pharmaceutical Management that provides
pharmaceutical industry professionals with a Master of Business Administration
degree with an emphasis in health administration and pharmaceutical management
in 25 months. Professionals in the pharmaceutical industry are being faced
with management issues that are complex and involve other key players in the
health care industry. Students will learn about global issues in a
classroom environment that includes a wide variety of healthcare professionals.
http://www.pharmcast.com/BuyersGuide/UColorado/UColoradoMBAInfo.htm
+++ PharmCast.com's Conference Highlight
+++
1, Effective Document Management for the Pharmaceutical, Biotech, and Medical Device Industries, October 4-5, 2007, Malvern, PA. Organized by The Center for Professional Innovation & Education.
http://www.cfpie.com/showitem.aspx?productid=027&source=pharmcast
2. Web Seminar: Investigating Out-Of-Specification (OOS) Test Results for Pharmaceutical Production, September 20, 2007. Speaker: Lic. Johnny Guerra; President, Guerra Consulting Group Inc. Organized by BenAstrum, Inc. (Use promotional code PC0907 for 10% discount).
3. ePharma Summit 2008, January 28-30, 2008, Philadelphia, PA. Organized by the Institute for International Research.
4. 5th Annual World Health Care Congress (WHCC). April 21-23, 2008, Washington, DC. Organized by World Congress. ($300.00 discount to PharmCast.com's visitors; use code: MPR729)
http://www.worldcongress.com/events/HR08000/index.cfm?confCode=HR08000
5. 5th Annual Healthcare M&A & Corporate Development, September 24-25, 2007, Nashville, TN. Organized by Strategic Research Institute.
http://www.srinstitute.com/healthcarema
6. 3rd Annual Merging Electronic Health Records & eClinical Technologies, September 24-25, 2007, Annapolis , MD. Organized by ExL Pharma.
http://www.exlpharma.com/eventDetail.php?id=86
7. Pharmaceutical Co-Crystals, September 24-26, 2007, Amsterdam, Netherlands. Organized by IQPC.
http://www.iqpc.com/nl/cocrystals/pharmcast
8. FDA Boot Camp Chicago Basic Training for Products Liability and Patent Lawyers, September 25-26, 2007, Chicago, IL. Organized by American Conference Institute.
http://www.americanconference.com/Pharmaceuticals_Biotech_Life_Sciences/fdabootcampchi.htm
+++ PharmCast.com's Last Week
Pharmaceutical Patents +++
http://www.pharmcast.com/PatentToSubWeb/Yr2007/Aug2007/Home082807OG.htm
1. Live genetically attenuated malaria vaccine
2. Fusion protein construct and method for inducing HIV-specific serum IgG and secretory IgA antibodies in-vivo
3. Treatment for wounds
4. Kits containing rank polypeptides
5. Lactoferrin in the treatment of diabetes mellitus
6. Adenoviral vector with replication-dependent transgene expression
7. Antagonistic anti-hFAS ligand human antibodies and fragments thereof
8. Clostridial toxin derivatives and methods for treating pain
9. Modulation of immunostimulatory activity of immunostimulatory oligonucleotide analogs by positional chemical changes
10. Rapid and efficient capture of DNA from sample without using cell lysing reagent
11. 1-N-arylpyrazole derivatives in prevention of arthropod-borne and mosquito-borne diseases
12. Humanised antibodies
13. Method for antimicrobial susceptibility testing of microorganisms
14. Methods of treating Syndrome X with aliphatic polyamines
15. Immune responses against HPV antigens elicited by compositions comprising an HPV antigen and a stress protein or an expression vector capable of expression of these proteins
16. Method for producing a synthetic gene or other DNA sequence
17. Antibodies to cytokines in the prevention and treatment of inflammatory bowel disease
18. Disinfectant and method of making
19. Lipid emulsions in the treatment of systemic poisoning
20. Cell lines for the propagation of mutated herpes viruses
+++ PharmCast.com's Last Week Federal
Register +++
http://www.pharmcast.com/FederalRegistrar/FRHome.htm
September 14, 2007
Executive MBA in Pharmaceutical Management, U. Colorado
1. Notice: Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents: Frequently Asked Questions; Availability
September 13, 2007
1. Notice: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
September 12, 2007
1. Notice: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 018
2. Notice: National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Draft Performance Standards for the Murine Local Lymph Node Assay: Request for Comments
September 10, 2007
1. Final Rule: April 2007 Revision of Patent Cooperation Treaty Procedures
2. Notice: Prospective Grant of Exclusive License: Use of Lecithin-Cholesterol Acyltransferase (LCAT) To Reduce Accumulation of Cholesterol
+++ PharmCast.com's Last Week Recent FDA
Links +++
http://www.pharmcast.com/FDALinks/FDALinksLatest.htm
September 14, 2007
1. 12th Annual GMP by the Sea - 8/27/2007 (Posted
9/14/2007)
a. CBER Update (PDF - 211 KB) - Mary Malarkey
September 13, 2007
1. Guidance for Industry and FDA Staff: Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions (Posted 9/13/2007)
2. Fentora (fentanyl buccal tablet) - Cephalon issues two Dear Healthcare Professional Letters to inform prescribers and other healthcare providers of important safety information regarding Fentora (9/13/2007)
3. Guidance for Industry and FDA Staff: Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions (Posted 9/13/2007)
4. Influenza Virus Vaccine 2007/2008 Season Lot Release Status - Update (Posted 9/13/2007)
5. Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book (9/13/2007)
September 11, 2007
1. FDA issues an FDA Alert and Healthcare Professional sheet for Rocephin (ceftriaxone) clarifying concomitant use with calcium-containing products or solutions. Drug Information (9/11/2007)
2. SOPP 8795: Posting and Announcement of Premarket Approval Application Approvals and Denials (Posted: 9/11/2007)
September 10, 2007
1. CDER on CMC: 21st Century Pharmaceutical Manufacturing and Control Strategies – A Changing Paradigm, October 15-16, 2007 Bethesda North Marriott Hotel & Conference Center. Meeting information (9/10/2007)
2. Pfizer issues a Dear Healthcare Professional Letter to inform healthcare professionals of the presence of ethyl methanesulfonate in Viracept (nelfinavir mesylate). MedWatch Safety Information (9/10/2007)
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