Navigation Links
Barnett Releases IND Submissions: A Primer
Date:2/25/2009

Barnett International, a division of Cambridge Healthtech Institute, has announced the release of IND Submissions: A Primer, an in-depth guide to writing, editing, tracking, and submitting the original IND and applicable IND amendments. IND Submissions: A Primer is the only comprehensive IND manual of its kind.

Needham, MA (PRWEB) February 25, 2009 -- IND Submissions: A Primer provides a "hands-on" approach that teaches regulatory professionals - novice and veteran alike - to work with the regulations, guidance documents, content templates, contributing authors, and style guides necessary to write an IND. The book's writing tips show regulatory professionals how to produce a range of U.S. drug and biologics submissions that comply with the requirements and are also clear to read. Included with the book is a CD filled with electronic examples.

The 600-page, spiral-bound, hardcover book is easy to use, providing step-by-step instructions on how to plan, write, and submit regulatory documents. Each chapter (62 in total) is divided by easy-to-read tabs.

IND Submissions: A Primer is the ideal resource for new professionals entering the field, a useful training guide, and a valuable reference for the experienced professional. This comprehensive "how-to" guide contains:

  • Regulations and guidance document references
  • Overview and background of why the submission is required
  • Structure of the submission itself
  • Details on who should contribute to the submission
  • Where to pull, re-use, or start as a basis for information needed in a submission
  • Tips and lessons learned from the author's experience
  • Different perspectives on how a submission can be approached
  • Applicable FDA Form 1571
    '/>"/>

Source: PRWeb
Copyright©2009 Vocus, Inc.
All rights reserved

Page: 1 2 3 4

Related medicine news :

1. Dr. Henry Barnett becomes first person outside Europe to receive Karolinska Stroke Award
2. Barnett Releases Reference Guide on Form FDA 1572--Statement of Investigator
3. pMDsoft Releases Charge Capture Software for BlackBerry Storm
4. Teva Releases Second Video in Year of Affordable Healthcare Campaign
5. DaVita Releases Top Clinical Priorities for 2009
6. Carestream Molecular Imaging Releases Western Blot Kits For Added Convenience, Better Performance
7. Moet & Chandon Releases Grand Vintage 1929 Magnum Commemorating First-Ever Academy Awards(R) To Benefit Motion Picture & Television Fund
8. PA DEP Releases Quarterly Mammography Inspections
9. Thomson Reuters Releases 2009 Patent Focus Report
10. Lumension Releases Annual Cybersecurity Report in Tandem with "Optimal Security" Blog Launch
11. Golden Meditech Releases FY2008/09 Q3 Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/28/2015)... Today the National Resident Matching Program (NRMP®) ... Main Residency Match®. A record-number 30,212 positions were ... the matching algorithm was processed. Of the 1,306 ... Week Supplemental Offer and Acceptance Program® (SOAP®) leading up ... the outcome of the 2015 Main Residency Match. A ...
(Date:5/28/2015)... 28, 2015 The Clinical Data ... that the International Organization for Standardization (ISO) now ... (BRIDG) Model version 3.2 as a published, Final ... with healthcare. This standard, which had previously passed ... was unanimously approved on 24 April for publication ...
(Date:5/28/2015)... The Boys & Girls Club of Atlantic City ... Blue Shield of New Jersey (Horizon BCBSNJ) and through the ... receive much more support as play begins for the 2015 ... & Girls Club member and volunteer with the organization as ... accepted the Horizon Blue Cross Blue Shield of New Jersey ...
(Date:5/28/2015)... 2015 Are policies that spell out ... stay triggering financial pain for seniors? That’s what a ... Managed Care set to figure out, and its findings ... change. , The study, “Observation Encounters and Subsequent Nursing ... MPH, examined how Medicare policies that distinguish between an ...
(Date:5/28/2015)... (PRWEB) May 28, 2015 ISMETT , ... Palermo, Italy, boosted the Sicilian economy by €132.5 million in ... net benefit of more than €73 million by retaining patients ... according to a new study by the Battelle Memorial Institute. ... to research, training and advanced health care management that is ...
Breaking Medicine News(10 mins):Health News:NRMP Releases Results and Data: 2015 Residency Match: Record Number of Positions Filled 2Health News:NRMP Releases Results and Data: 2015 Residency Match: Record Number of Positions Filled 3Health News:CDISC Announces BRIDG Model for Research as Final ISO Standard 2Health News:CDISC Announces BRIDG Model for Research as Final ISO Standard 3Health News:Golf Pro Natalie Gulbis to Chip in with Horizon Blue Cross Blue Shield of New Jersey to Support Boys & Girls Club of Atlantic City 2Health News:Golf Pro Natalie Gulbis to Chip in with Horizon Blue Cross Blue Shield of New Jersey to Support Boys & Girls Club of Atlantic City 3Health News:AJMC Study Examines Effect of Medicare Rules on Care After Hospital Observation 2Health News:AJMC Study Examines Effect of Medicare Rules on Care After Hospital Observation 3Health News:UPMC-Managed Transplant Hospital Drives Major Economic Benefits for Sicily, Study Finds 2Health News:UPMC-Managed Transplant Hospital Drives Major Economic Benefits for Sicily, Study Finds 3
... , This release is available in French ... group AGR 206 at the University of Granada ... "Jose Matix", coordinated by professor Margarita Snchez Campos , ... health. The regular consumption of goat milk by individuals ...
... 17, 2011 Columbia University,s Mailman School of Public Health ... public healththe Frank A. Calderone Prizeto Harvey V. Fineberg, MD, ... of the National Academy of Sciences. The Frank A. Calderone ... presented to an individual who has made a transformational contribution ...
... A Wednesday morning session will explore the ... to Iraq and Afghanistan. Presenters will review current ... toxicology studies, and clinical lung findings in U.S. ... Southwest Asia. D6 "Occupational Lung Diseases in ...
... , WEDNESDAY, May 18 (HealthDay News) -- Voter registration cards ... and cherish than personality or appearance, new research suggests. ... own, according to a study from Rice University and the ... the Journal of Politics , examined the physical, personality ...
... PLoS Medicine , Groesbeck Parham from the Centre ... their Cervical Cancer Prevention Program, which has provided services ... The authors share lessons learned from the program,s implementation ... help other cervical cancer prevention initiatives succeed in the ...
... By Jenifer Goodwin HealthDay Reporter , TUESDAY, ... Drug Administration advisory committees plan to meet Tuesday and ... instructions on the labels of medicines containing acetaminophen need ... of 2 against possible liver failure and even death. ...
Cached Medicine News:Health News:Scientific study proves that goat milk can be considered as functional food 2Health News:Highest prize in public health awarded to Dr. Harvey V. Fineberg 2Health News:Highest prize in public health awarded to Dr. Harvey V. Fineberg 3Health News:Occupational lung diseases in Iraq and Afghanistan veterans 2Health News:Politics May Trump Looks, Personality in Matters of the Heart 2Health News:FDA Panels to Weigh Dosing Labels for Kids' OTC Fever Relievers 2Health News:FDA Panels to Weigh Dosing Labels for Kids' OTC Fever Relievers 3Health News:FDA Panels to Weigh Dosing Labels for Kids' OTC Fever Relievers 4
(Date:5/28/2015)... , May 28, 2015  IRIDEX Corporation (NASDAQ: IRIX ... Officer James H. Mackaness is scheduled to present ... at 9:00 am PT in Los Angeles ... may be accessed on the Event Calendar of the Investors ... of the webcast will be available shortly after the conclusion ...
(Date:5/28/2015)... 2015 This report analyzes the worldwide markets for ... following Segments: Standard Intraocular Lenses, and Premium Intraocular Lenses. The ... Canada , Japan , ... Latin America , and Rest of World. Annual estimates ... Also, a seven-year historic analysis is provided for these markets. ...
(Date:5/28/2015)... Calif. , May 28, 2015 Isis ... webcast:What: , Akcea Therapeutics WebcastWhen: , Thursday, June 4 ... www.isispharm.com How: , Live on the Internet.  Simply ... unable to participate during the live event, a replay ... time at www.isispharm.com . ABOUT ISIS ...
Breaking Medicine Technology:World Intraocular Lenses Industry 2World Intraocular Lenses Industry 3World Intraocular Lenses Industry 4World Intraocular Lenses Industry 5World Intraocular Lenses Industry 6World Intraocular Lenses Industry 7World Intraocular Lenses Industry 8World Intraocular Lenses Industry 9World Intraocular Lenses Industry 10World Intraocular Lenses Industry 11World Intraocular Lenses Industry 12World Intraocular Lenses Industry 13World Intraocular Lenses Industry 14World Intraocular Lenses Industry 15World Intraocular Lenses Industry 16World Intraocular Lenses Industry 17World Intraocular Lenses Industry 18World Intraocular Lenses Industry 19World Intraocular Lenses Industry 20World Intraocular Lenses Industry 21World Intraocular Lenses Industry 22World Intraocular Lenses Industry 23World Intraocular Lenses Industry 24World Intraocular Lenses Industry 25World Intraocular Lenses Industry 26Webcast Alert: Akcea Therapeutics Conference Call 2Webcast Alert: Akcea Therapeutics Conference Call 3
... Ind., May 27, 2011 Hill-Rom Holdings, Inc., (NYSE: ... presentation at the Goldman Sachs 32nd Annual Health Care Conference ... EDT. You are invited to listen to the ... or access it directly at http://cc.talkpoint.com/gold006/060711a_lr/?entity=37_TJC531W .  A recorded ...
... Express Scripts, Inc. (Nasdaq: ESRX ) ... repurchase, or ASR, transactions with Morgan Stanley to purchase ... purchase price of $1,750 million.  Under the terms of ... million shares of its stock.  At the end of ...
Cached Medicine Technology:Express Scripts Announces Accelerated Share Repurchase Transactions 2
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
Medicine Products: