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AGENCY WEBSITES
STANDARDS ORGANIZATIONS
INDUSTRY
ASSOCIATIONS
 | PDA:
Advances pharmaceutical and biopharmaceutical technology
internationally by promoting scientifically sound and practical
technical information and education for industry and regulatory
agencies. Publishes PDA
Letter and PDA
Journal. |
| PharmWeb
- PharmWeb Discussion Forum:
A
PDA sponsored online forum that serves as a platform for
exchanging practical, and sometimes theoretical, ideas within
the context of some of the most challenging issues confronting
the pharmaceutical industry.
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| R3Nordic:
Nordic Association for Contamination Control and Clean Rooms (Sweden,
Denmark, Norway and Finland). Interests encompass
contamination control and other systems targeted at achieving
low levels of contamination and high levels of performance
assurance for the protection of personnel and products, and
including issues relating to maintenance of systems and
operating procedures. |
| American
Association of Pharmaceutical Scientists: A
professional, scientific society of more than 10,000 members
employed in academia, industry, government and other research
institutes worldwide. Aims to advance science through the open
exchange of scientific knowledge, serve as an information
resource, and contribute to human health through pharmaceutical
research and development. |
| Drug
Information Association (DIA): A neutral, global
forum, completely independent from the influence of any one
organization or authority, in which you can learn about
advances, issues, regulations, and trends from the perspective
of healthcare companies, academic institutions, and governmental
regulatory agencies alike. |
| International
Federation of Pharmaceutical Manufacturers Association (IFPMA):
A non-profit, non-governmental Organization (NGO) representing,
through our member associations, the worldwide research-based
pharmaceutical industry and manufacturers of prescribed
medicines. Three primary tasks: Develop global position
statements on matters of health care policy. Encourage the
global exchange of information within our industry. Work closely
with international organizations dedicated to health and
trade-related issues. |
| Institute
of Validation Technology (IVT): Dedicated to expanding
the global knowledge base for validation and compliance
professionals in FDA-regulated industries through educational
publications, timely conferences, and other informational
products. |
| Pharmaceutical
Research and Manufacturers of America (PhRMA): Represents
the country's leading research-based pharmaceutical and
biotechnology companies. Conducts advocacy for public
policies that encourage discovery of important new medicines for
patients by pharmaceutical/biotechnology research companies. |
| The
Parenteral Society: Information concerning all aspects
of parenteral technology and parenteral administration.
Education and training of personnel in the fields of parenteral
technology and administration. |
OTHER INDUSTRY LINKS
| RMC
Pharmaceutical Solutions Inc.: RMC Pharmaceutical
Solutions (RMCPS), is ready to help you conquer your
challenges during pharmaceutical, biotech and combination
(drug/device) product development and commercialization
activities. The RMCPS team offers expertise in quality and
compliance systems, validation and calibration controls,
product/process development and validation, strategic planning,
due diligence, and project management. The foundation and scope
of this team expertise has been obtained through nearly 60 years
of collective experience across start-up, development and
commercial-stage organizations. |
| Biopharm
International: BioPharm provides a peer-reviewed forum
for its readers to exchange practical, hands-on information for
developing and manufacturing pharmaceutical products through
biotechnology; and it provides a supportive, authoritative voice
in the evolving business, regulatory, scientific, and technical
areas of the biopharmaceutical industry.
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| Pharmaceutical
Engineering: Feature articles provide practical
application and specification information on the design,
construction, supervision, and maintenance of process equipment,
plant systems, instrumentation, and facilities.
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| Dickinson's
FDA Webview: Interactive Web site that watches
the U.S. Food and Drug Administration all day long. From the
leading publisher of FDA-content business newsletters since
1984, you can monitor regulatory, legal, policy and scientific
news affecting all FDA-regulated healthcare products and their
marketing activities. Also has links to its print
newsletters.
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| fdainfo.com:
How to find FDA documents and other regulatory news and
information. Links and info for several newsletters and
reports.
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| foi
online: Freedom of Information documents available
on-line, anonymously.
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| Pharmaceutical
Online: Links to products and suppliers, relevant
content and industry news. Serves the needs of pharmaceutical
professionals working on pharmaceutical scale-up, pharmaceutical
contract manufacturing, pharmaceutical clinical trials,
production, processing, manufacturing, engineering, and related
regulatory and policy issues.
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| FDA
News.com: Exclusive news and analysis on drugs,
medical devices and biologics.
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| The
Gold Sheet: Designed for manufacturing and quality control
managers concerned with quality control procedures and FDA
regulatory and enforcement activities in the pharmaceutical and
biological industries. The publication covers developments in
FDA regulations and policies governing the manufacture and
processing of healthcare products and state-of-the-art
production and quality techniques.
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FDA
on Harmonization |
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Forces
Shaping Biological and Biotechnology Products in the
21st Century:
... Global
Market: International Harmonization and
Competition
Chris
Joneckis, Ph.D., FDA
March 2003
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