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ORGANIZATIONS

Association of the British Pharmaceutical Industry
www.abpi.org.uk
This site provides information and statistics on the pharmaceutical industry,
ABPI publications, as well as education, training, and career resources.

Association of Clinical Research Organizations
http://www.acrohealth.org
The ACRO site highlights the key issues for CROs and also provides market
trends. In addition, it also acts as a resource for pharma and biotech sponsors,
patients, and patient advocates.

Association of Clinical Research Professionals
http://www.acrpnet.org
Beyond its extensive training and education resources, ACRP is a one-stop
source for public policy updates. Also available to its members is an online
community, including eForums, a member directory, and a resource library.

Biotechnology Industry Organization
http://www.bio.org
BIO's site provides information regarding national, state, and local issues of
industry. Users can also find BIO news, blogs, and podcasts through this site.

CDISC, Clinical Data Interchange Standards Consortium
http://www.cdisc.org
Provides free downloadable CDISC standards, news on the latest initiatives, an
active discussion board, links to regulatory documents and published articles,
and a CDISC Glossary of clinical research terms, acronyms, and abbreviations.

CISCRP, Center for Information & Study on Clinical Research Participation
www.ciscrp.org
Visitors can find a wealth of information and resources—facts, figures, Web
sites—and have the chance to connect with patients, caregivers, and families
by joining the Clinical Research Volunteers Community.

Clinical Trials Transformation Initiative
https://www.trialstransformation.org
Laying out the background, scope, and principles of this initiative, the site also
provides an area for any interested party to submit a project idea, information
on becoming a member, as well as a breakdown of the members behind CTTI.

Drug Information Association
http://www.diahome.org
Find out about upcoming DIA events, webinars, training, internships, and
certification programs. DIA's online community is for members only, but
non-members are still able to access the job bank and view resumes.

EFGCP: Impact on Clinical Research of European Legislation
http://www.efgcp.be/ICREL/
A report that aims to measure and analyse the direct and indirect impact of the
Clinical Trials Directive2001/20/EC and related legislations in the EU.

EPEMED: European Personalized Medicine Association
http://www.epemed.org/
A not-for-profit organization bringing together global forces in personalized medicine.

EUCROF: The European CRO Federation
http://www.eucrof.eu/
An orgaization that aims to promote clinical research of high quality in Europe in general and in the European Union in particular.

HL7, Health Level 7
http://www.hl7.org
Six main categories make up this standards developing organization's site:
About HL7, Events, Members Only, Membership, Resources, and Work
Groups. Most resources are accesible to nonmembers, including the bookstore.

Pharmaceutical Research and Manufacturers of America
http://www.phrma.org
Visitors can find PDFs on topics like cancer and women's health, instructional
videos, helpful links, a database that lists drugs currently in clinical trials or
at FDA for review, and reports on medicines in development.

Regulatory Affairs Professionals Society
http://www.raps.org
Visitiors can make use of professional advancement opportunities, pick up
a Title 21 CFR Pocket Guide at the bookstore, scan for a new job or
employee, check out upcoming meetings, or peruse the available coureses.

Society for Clinical Data Management
www.scdm.org
An educational portal leads to SCDM's upcoming webinars as well as
numerous resources for the clinical data manager certification exam,
which SCDM offers. The site also features a job postings section.

Society of Clinical Research Associates
www.socra.org
Find upcoming meetings, conferences, and in-person courses. Make use of
instructions for submitting articles for the SoCRA Source journal, a classified
section for clinical research jobs, and information on certification programs.

Society of Quality Assurance
www.sqa.org
The purpose of this site is to serve the needs of members,
and to inform prospective members and the general public about SQA, what
opportunities it offers and what its members do.

FDA SITES

FDA Home Page
www.fda.gov
Providing information for consumers, industry, and health professionals,
this site covers current science and research, regulations and laws, background
information about the FDA, new drug approvals, and drug safety information.

FDA Electronic Submissions Gateway
http://www.fda.gov/esg
Enabling the submission of regulatory information for review, this is the
FDA's Agency-wide solution for accepting electronic regulatory submissions.

FDA–European Union
http://www.fda.gov/oia/EC_EMEA.htm
This site covers the international activities taking place between the FDA
and Euoropean Union's European Agency for the Evaluation of Medicinal
Products and European Commisson.

FDAAA Implementation Chart
http://www.fda.gov/oc/initiatives/advance/fdaaa/implementation_chart.html
A chart overviewing the implementation of the FDA Amendments Act of
2007, including the effected section of the Agency, a description of necessary
actions, a target date, the actions completed, and an agency contact for each.

Current Guidances
http://www.fda.gov/opacom/morechoices/industry/guidedc.htm
This site provides all guidance documents set out by the FDA, organized
by the Agency's different centers and also including those from the
Office of the Commissioner.

The Center for Biologics Evaluation and Research (CBER)
http://www.fda.gov/cber/guidelines.htm
Find information regarding the different types of products CBER regulates,
read documents frequently requested by the Freedom of Information Act,
and learn about training programs, meetings, and research in this area.

The Manual of Regulatory Standard Operating Procedures and Policies
http://www.fda.gov/cber/regsopp/regsopp.htm
This manual covers the procedures and policies that are in place for
operations that take place within the FDA.

The Center for Drug Evaluation and Research (CDER)
http://www.fda.gov/cder/
The official site for the drug branch of the FDA, which includes news,
general safety and side effects information, new drug approvals,
and alerts and warnings for approved drugs. Visitors can also find details
on
guidances developed by the agency and enforcement information.

Sign up for E-mail to the CDER Web site
http://www.fda.gov/cder/cdernew/listserv.html
All available CDER mailing lists.

Questions and Answers on Current Good Manufacturing Practices (cGMPs) for Drugs
http://www.fda.gov/cder/guidance/cGMPs/default.htm
CDER's question and answer resource on the meaning and application
of cGMPs for drugs.

The Data Standards Manual
http://www.fda.gov/cder/dsm/index.htm
This manual compiles all of the standardized nomenclature monographs
that have been reviewed and approved by the FDA Data Standards Council.

Guidance documents specific to CDER
http://www.fda.gov/cder/guidance/index.htm
A record of guidance documents arranged by subject, as well as links to
additional information about guidances, including updated lists of ones that
are new, revised, or withdrawn.

The CDER Handbook
http://www.fda.gov/cder/handbook/index.htm
Users can find information on all of the review and approval processes
CDER is responsible for, contact details for people within the Center, as
well as a search option for FDA acronyms and abbreviations.

CDER's regulatory guidance section
http://www.fda.gov/cder/regulatory
A comprehensive list of CDER's guidances and enforcement information.

The Office of Regulatory Affairs (ORA)
http://www.fda.gov/ora
A resourceful site that includes compliance, inspectional, and science references,
a list of popularly requested documents, recent ORA publications, and hot
topics, such as training courses, GLP and AIP lists, and ORA events.

FDA and ORA site
http://www.fda.gov/ora/compliance%5Fref
Find links to all content related to Compliance References used by FDA personnel.

The Compliance Policy Guide
http://www.fda.gov/ora/compliance%5Fref/cpg
Revisions and updates to ORA's Compliance Policy Guides Manual,
dating from 1998 to present.

Guide to Inspections
http://www.fda.gov/ora/inspect_ref/igs/iglist.html
This site provides reference materials for investigators and FDA personnel
for inspections.

The Guide to Inspection of Quality Systems
http://www.fda.gov/ora/inspect_ref/igs/qsit/qsitguide.htm
A document providing guidance to FDA field staff on a new inspectional
process, the Quality System Inspection Technique
.

ADDITIONAL GOVERNMENT SITES

Centers for Medicare & Medicaid Services
http://www.cms.hhs.gov
This site provides a listing of different CMS programs and detailed
information for each, an up-to-date newsroom, the top 10 links on the
site, as well as numerous links related to research, statistics, and data.

Children and Clinical Studies
http://www.nhlbi.nih.gov/childrenandclinicalstudies/index.php
The National Heart Lung and Blood Institute here offers an entire site
dedicated to the practice of clinical research in children.

European Medicines Agency
http://www.emea.europa.eu
The official EMEA site includes basic Agency information, including its
committees, events, meetings, job opportunities, and press releases. Beyond
this, there's information on products, EU legislation, and emerging science.

National Institutes of Health
http://www.nih.gov
Along with a detailed overview of the Agency, the site provides an A-Z
index of health topics, grant information, current industry news, research
results, and a listing of the institutes, centers, and offices that make up the NIH.

Agency for Healthcare Research and Quality (AHRQ)
http://www.ahrq.gov
AHRQ supplies a variety of clinical information ranging from scientific
reviews, treatment and research findings, comparative clinical effectiveness,
and technology reviews to current and archived clinical practice guidelines.

BLOGS

Applied Clinical Trials Blog
blog.appliedclinicaltrialsonline.com
The Applied Clinical Trials blog offers area of discussion on news and
analysis of the business and trends in the clinical trials industry.

BioClinica Trial Blazers Blog
http://info.bioclinica.com/blog
BioClinica's Trial Blazers blog covers the latest news on clinical trials direct from industry experts.

Carl's Blog on FDA Stuff
http://carl1anderson.wordpress.com/
Carl Anderson, a regulatory affairs and quality assurance consultant, provides
current information about issues pertaining to the FDA. The blog also has links
to organizations and relevant articles.

ClinPage
www.clinpage.com
Offers a broad range of industry news, events, statistics, and trends.
Users can also find podcasts of interviews with clinical trials professionals.

Drug and Device Law
http://druganddevicelaw.blogspot.com
This blog is devoted to discussing topics related to pharmaceutical and
medical device product liability litigation.

EyeOnFDA
http://www.eyeonfda.com
This blog covers the regulatory aspects of medical products. Users can
also find FDA links, industry news updates, and links to relevant videos
on YouTube.

In the Pipeline
http://pipeline.corante.com
Authored by an organic chemist, this blog focuses on the science side of
drug discovery. With daily posts it touches upon topics in the news and
issues arising in industry keeping readers in touch with what's happening.

The In Vivo Blog
http://invivoblog.blogspot.com
Here readers can find daily commentary on recent developments in bio-
pharmaceutical business development, drug development, finance,
marketing, and policy.

Medical Translation Blog
http://blog.fxtrans.com/
Created by Foreign Exchange Translations, a medical translation company,
this blog provides content on regulatory issues, technology, and of course,
topics of medical translation.

Pharmaceutical Executive
http://blog.pharmexec.com/
Discourse, dialogue, and discussion about global pharma matters.

Pharmalot
http://www.pharmalot.com/
Information on all topics of concern to professionals in the drug development
industry as well as an up-to-date listing of news.

PRIM&R's Amp&rsand
http://primr.blogspot.com
Public Responsibility in Medicine and Research (PRIM&R) provides
through its blog, discussions on ethic-related topics.

Wall Street Journal's Health Blog
http://blogs.wsj.com/health
Covering health and the business of health, WSJ's health blog presents
analysis of the latest news in industry.

TOOLS

Applied Clinical Trial's Professional Associations Listing
http://appliedclinicaltrialsonline.findpharma.com/Associations2011
Interdisciplinary networking, publications, and conferences are a few of the
benefits of society membership.

Applied Clinical Trial's Training and Education Directory
http://appliedclinicaltrialsonline.findpharma.com/Training2011
Organizations offering courses and classes designed to broaden your
clinical trials knowledge base.

Canada Trials
http://canadatrials.com
Both patients and researchers can find here clinical trials information in
Canada. Along with finding medical news, patients can find support groups,
researchers can post a trial, and sponsors can search center profiles.

CDISC Acronyms, Abbreviations, and Initials
http://www.appliedclinicaltrialsonline.com/Abbrev2009
These translations help make sense of initials commonly used by clinical
researchers around the world.

CDISC Clinical Research Glossary
http://appliedclinicaltrialsonline.findpharma.com/Glossary
A newly updated glossary that includes even more terms relevant to clinical
trials professionals.

CenterWatch Clinical Trials Listing Service
www.centerwatch.com
Beyond being a global news source for clinical research professionals and
patients, CenterWatch offers directories, analysis, and market research.

Clinicaltrials.gov
http://www.clinicaltrials.gov
As a service of the U.S. National Institutes of Health this is a registry of
federally and privately supported clinical trials conducted globally.

The Federal Register
http://www.gpoaccess.gov/fr/index.html
A Web-based filing of the rules, proposed rules, and notices of Federal
agencies and organizations, as well as executive orders and other presidential
documents, which are provided from the year 2000 and on.

PhRMA Clinical Study Results Database
www.clinicalstudyresults.org
A Web-based repository for clinical study results presented in a reader-
friendly, standardized format.

Practical Considerations for Clinical Trial Sites Using Electronic Health Records Certified for Clinical Research
www.eclinicalforum.org/Default.aspx?id=75&tabid=54
This paper from the EHRCR Project addresses regulatory considerations regarding clinical trial sites using electronic health records.

WHO International Clinical Trials Registry Platform (ICTRP)
www.who.int/ictrp/en
This site facilitates access to worldwide information about controlled trials
and their results, trial registration, datasets, and news.

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