Resources
 

Pharmaceutical Industry Organizations

Medical Device Industry Organizations

U.S. Regulatory Sites

Clinical Research Sites

International Regulatory / Advisory Sites

Miscellaneous New Drug, Biologics or Device Sites

RegulatoryPro Presentations


Pharmaceutical Industry Organizations


http://www.aapspharmaceutica.com/

American Association of Pharmaceutical Scientists (AAPS)

 

http://www.chpa-info.org/

Consumer Healthcare Products Association (CHPA)

        

http://www.gphaonline.org/

Generic Pharmaceutical Association (GphA)

 

http://www.pda.org/

Parenteral Drug Association (PDA)

 

http://www.phrma.org/

Pharmaceutical Research and Manufacturers of America (PhRMA)

 

http://diahome.org

Drug Information Association

 

http://www.ispe.org/

International Society for Pharmaceutical Engineering

 

http://www.ipecamericas.org/

International Pharmaceutical Excipients Council of the Americas

 

http://www.fdli.org/

Food and Drug Law Institute

 

http://www.pqri.org

Product Quality Research Institute

 

http://www.pharmweb.net/

Pharmweb - pharmaceutical web

 

http://www.bio.org

Biotechnology Industry Organization (BIO)

 


Medical Device Industry Organizations


http://www.regsource.com/

Regsource

 

 http://www.devicelink.com/

Medical Devicelink

 

Association for the Advancement of Medical Instrumentation (AAMI)

 

The GMP Institute

 

Health Industry Manufacturers Association (HIMA)

 

Medical Device Manufacturers Association (MDMA)

 

Massachusetts Medical Device Industry Council (MassMEDIC)

 

Medical Device Link

 

Regulatory Affairs Information Homepage-

 

The Medical Device Forum

 


U.S. Regulatory Sites


http://www.fda.gov/

U.S. Food and Drug Administration

 

http://www.fda.gov/cder

U.S. FDA, Center for Drug Evaluation and Research

 

http://www.fda.gov/cber/

U.S. FDA, Center for Biologics Evaluation and Research

 

http://www.fda.gov/cdrh/

U.S. FDA, Center for Devices and Radiological Heath

 

http://www.access.gpo.gov/ecfr/

U.S. Government Printing Office, Electronic Code of Federal Regulations

 

http://www.access.gpo.gov/su_docs/regulatory.html

Regulatory resourses on the Government Printing Office Access site

 

http://www.regulations.gov/

U.S. Federal documents open for comment and published in the Federal Register, the Government’s legal newspaper

 


Clinical Research Sites


 

http://www.acrpnet.org/

Association of Clinical Research Professionals (ACRP)

 


International Regulatory / Advisory Sites


 

http://www.who.int/en/

World Health Organization

 


Miscellaneous New Drug, Biologics or Device Sites


 

Tufts Center for Drug Development/Tufts University

http://csdd.tufts.edu/

 

Search the Federal Register

http://www.gpoaccess.gov/fr/index.html

 


RegulatoryPro Presentations


 


   July 2005 Meeting Presentation

Regulatory Affairs for the Non-regulatory Medical Device Professional  Presentation formats:   (Powerpoint)     (Acrobat PDF)


 

Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach

 

Powerpoint format                                         Portable Document format